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1-05-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program GlaxoSmithKline and FDA notified healthcare professionals about post-marketing reports of new onset and worsening diabetic macular edema for patients receiving rosiglitazone. In the majority of these cases, the patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved following discontinuation of therapy and in one case, macular edema resolved after dose reduction.
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1-06-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Cangene, Baxter Healthcare and FDA notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information to address two important safety concerns. 1] Postmarketing safety surveillance has shown rare, but severe and sometimes fatal, intravascular hemolysis and potentially serious complications, including disseminated intravascular coagulation in patients with ITP. 2] Maltose in IVIG products, such as the liquid formulation of WinRho SDF, has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving this product.
1-10-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Ortho-Clinical Diagnostics and FDA notified healthcare professionals and clincal laboratory staff of a class 1 recall of the HBsAg Confirmatory Kit due to an unknown component in the diluting solution used to test blood and serum samples that may produce 'Not Confirmed' results for samples found to be positive with the initial test. This can cause some results to be classified as false negatives. False negative results may prevent some patients infected with or carrying the hepatitis B virus from receiving necessary treatment. This is especially true for pregnant women whose tests show false negative results. The company recommends that previously reported results be reviewed.
1-13-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novartis and FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, CONTRAINDICATIONS, PRECAUTIONS (Information for Patients and Pharmacokinetic-Related Interactions subsections), and ADVERSE REACTIONS (Postmarketing Clinical Experience subsection) sections of the prescribing information for Clozaril (clozapine) tablets. Recommendations from the FDA's Psychopharmacological Drugs Advisory Committee regarding the white blood cell monitoring schedule, required for all clozapine users, has resulted in modification in the monitoring schedule. Additional labeling changes address safety issues related to dementia-related psychosis, parlytic ileus, hypercholesterolemia and pharmacokinetic interaction with citalopram.
1-13-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA warned consumers not to use two unapproved drug products that are being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement may contain several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury. They contain chlordiazepoxide HCl (the active ingredient in Librium), and fluoxetine HCl (the active ingredient in Prozac). Emagrece Sim and Herbathin were also found to contain Fenproporex, a stimulant that is not approved for marketing in the United States. Consumers are advised not to use the Emagrece Sim and Herbathin products and to return them to the suppliers. There may be other manufacturers or suppliers of imported Emagrece Sim and Herbathin, and consumers should exercise caution in using any of these imported products.
1-19-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Roche Diagnostics and FDA notified healthcare professionals of a worldwide voluntary recall of specific ACCU-CHEK Aviva Meters, used to measure blood sugar levels, because of the potential for an electronic malfunction which can cause the meter to report an erroneous result or shut down and no longer be used. The recall includes U.S. serial numbers 52500000000 through 52510999999. This recall does not apply to meters with U.S. serial numbers 52511000000 and higher or ACCU-CHEK Aviva test strips.
1-20-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The Food and Drug Administration announced the approval of updated labeling for two topical eczema drugs, Elidel Cream (pimecrolimus)and Protopic Ointment(tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.
1-20-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases were also reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. As a part of this, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.
1-30-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Vapotherm, Inc. and FDA notified healthcare professionals about the class 1 recall of the Vapotherm 2000i and 2000h products, which deliver moisture to and warm breathing gases through a flexible nasal tube for patients receiving supplemental oxygen in home, hospital or sub-acute institutional settings. FDA received reports of Vapotherm units becoming contaminated with Ralstonia spp and other bacteria. Exposure to these bacteria may cause patients to develop tracheitis, sepsis, pneumonia, or other serious infections. There is a reasonable probability that immunocompromised patients or premature newborms could develop pneumonia or sepsis. FDA recommends the use of alternative devices until the source of the contamination has been identified. Patients who have been exposed to the Vapotherm system should be monitored for signs and symptoms that may suggest infection and clinicians may want to consider Ralstonia infection in the differential diagnosis of symptomatic patients even if the organism has not been isolated.
1-30-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The First Years and FDA notified consumers and healthcare professionals of the voluntary recall of liquid-filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain pseudomonas aeruginosa and pseudomonas putida which can cause serious illness in children if the teether is punctured and the liquid from the teether is ingested. The teethers were sold nationwide including major retailers, grocery, drug and specialty stores from July 2005 to January 2006. This recall is for 6 different styles of liquid-filled teethers for infants (3+ months old) to soothe gums. Consumers should stop using the recalled products immediately. No illnesses have been reported to date in connection with this problem.
2-06-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients about a Public Health Notification on continued risk of bacterial meningitis in children with cochlear implants. The notification provides new information about the risk of meningitis in children with cochlear implants with positioner beyond twenty-four months post-implantation. This new information is based on a CDC study that published in this month's issue of Pediatrics and updates previous FDA notifications from 2002 and 2003.
2-08-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a public health advisory and other advisory information to notify both healthcare professionals and consumers of recently published studies of serious renal and cardiovascular toxicity following Trasylol administration to patients undergoing coronary artery bypass grafting surgery (CABG). An observational study published in The New England Journal of Medicine reported that Trasylol may be associated with increased risk of myocardial infarction, stroke and renal dysfunction. Another publication (Transfusion, on-line edition, January 20, 2006) has reported that Trasylol administration may increase the risk for renal toxicity.
2-13-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia, associated with the use of benzocaine sprays used in the mouth and throat. Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways. On February 8, 2006, the Veterans Health Administration (VA) announced the decision to stop using benzocaine sprays for these purposes. The FDA is aware of the reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market. The FDA is highlighting safety information previously addressed by the Agency (see link below), has provided other information for the consideration of clinicians in the PHA and will make further announcements or take action as warranted by the ongoing review.
2-14-06
MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients of the request for recall of all brands and sizes of Balanced Salt Solution (BSS) manufactured by Cytosol Laboratories, Inc. because product lots were found to have elevated and dangerous levels of endotoxin. BSS is a drug used by health professionals to irrigate a patient's eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery. FDA has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome (TASS) which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction. FDA has also received complaints relating to injuries in over 300 patients who were given BSS manufactured by Cytosol Laboratories The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels: "AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.; "Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and "Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.
2-15-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Bayer and FDA notified healthcare professionals of changes to the prescribing information for nimodipine (Nimotop), including a boxed warning to notify prescribers about medication administration errors. Nimodipine is approved for oral administration to improve neurological outcome after subarachnoid hemorrhage. When administered intravenously or parenterally, it can cause serious adverse events, including death. Nimodipine must not be administered intravenously or by any parenteral route.
2-22-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Mead Johnson and FDA notified consumers and healthcare professionals of a recall of one lot, lot # BMJ19, of GENTLEASE powdered infant formula, found to contain metal particles up to 2.7 millimeter in size. If an infant were to inhale the infant formula into the lungs, the presence of these particles could present a serious risk to the infant's respiratory system and throat. There were approximately 41,464 24-ounce cans of this lot of recalled product distributed, beginning on December 16, 2005, through many major retail stores across the country, so the consumer should concentrate on the code on the can rather than on the place of purchase. The affected products can be identified by the lot number and expiration/use by date embossed on the bottom of the can of BMJ19, use by 1 Jul 07. Consumers who have a can of this batch of GENTLEASE powdered infant formula should not use the product and should contact Mead Johnson at 888-587-7275 immediately.
3-01-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Hanford Pharmaceuticals and FDA notified healthcare professionals about the recall of four lots (379,975 vials) of Cefazolin for Injection, USP, 1 g/10 mL vials, an antibiotic used in a hospital environment to treat skin and skin structure, respiratory and other infections.The product was distributed by Sandoz, Inc. of Broomfield, CO and Watson Pharmaceuticals, Inc. of Corona, CA. Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus) which may pose a serious or life-threatening risk for some patients. Hospitals, clinics, and users should stop using the affected lots immediately.
3-02-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA has issued an update to its August 2005 preliminary public health notification for the Gambro Prisma(r) Continuous Renal Replacement Therapy (CRRT) device, used for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Approximately 1,900 units have been distributed to hospitals in the United States. This device has caused or contributed to a number of serious adverse events by removing excessive amounts of fluid from patients undergoing CRRT. FDA is aware of 9 deaths and 11 serious injuries associated with the excessive fluid removal problem. Special caution must be used and caregivers must adhere strictly to the labeled operating instructions, including the Manufacturer's Instructions for Use, Operator's Manual, and the User Interface on the Prisma(r) System control panel.
3-02-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Actelion and FDA notified healthcare professionals of changes to the Tracleer(bosentan) prescribing information based on cases of hepatotoxity reported. Tracleer is indicated for the treatment of pulmonary arterial hypertension. The notification underscored the need to continue monthly liver function monitoring for the duration of Tracleer treatment and the need to adhere to the recommended dosage adjustment and monitoring guidelines described in the product labeling.
3-02-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of an update to the October 26, 2005 information paper on human tissues recoved by BioMedical Tissue Services (BTS). The tissue, including human bone, skin, and tendons, was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. As part of its ongoing investigation, FDA has become aware of additional information regarding the reliability of donor blood samples that is important for health care providers to consider. FDA strongly recommends that health care providers inform their patients who received tissue implants prepared from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing. While FDA believes the risks from these tissues are low because the tissues were routinely processed using methods to help to reduce the risk of infectious disease, the actual infectious risk is unknown.
3-03-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Bard/Davol and FDA notified healthcare professionals of a class 1 recall of Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
3-10-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The Food and Drug Administration (FDA) warned several manufacturers and distributors of unapproved drugs containing steroids that are marketed as dietary supplements and promoted for building muscle and increasing strength that the products may cause serious long-term adverse health consequences in men, women, and children. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, and short stature in children. Anabolic steroids are also associated with causing adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.
Consumers who have any of the following products should stop taking them and return them to their place of purchase:
3-30-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Valeant Pharmaceuticals and FDA notified healthcare professionals of complaints the company received concerning small cracks at the base of the plastic tip of the applicators with resulting leakage of the medication when the plunger is depressed, preventing full dosing and potentially resulting in a sub-optimal therapeutic response. Diastat is indicated for rectal administration in the management of selected refractory patients with epilepsy on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity. Healthcare professionals should advise patients using the product of this issue and to return any product with a cracked tip to their pharmacy for immediate replacement. Pharmacists should inspect all product on their shelves and contact Rx Hope at 1-800-511-2120 for replacement product.
4-01-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Ossur and FDA notified healthcare professionals of a voluntary worldwide recall of the 1100, 1900, 2000 and 2100 models of its Total Knee prosthetic device. The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. At this time, there have been no incidents or injuries resulting from this situation that have been reported to the company.
4--01-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Bard/Davol and FDA notified healthcare professionals of an expanded class 1 recall of Bard Composix Kugel Mesh Patch, used to repair ventral hernias caused by thinning or stretching of scar tissue that forms after surgery. The recall now includes Oval, Large Oval and Large Circle Kugel mesh patches. The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break and lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). Bard also issued letters to hospitals and health care professionals providing updated Instructions for Use, clarifying the proper insertion technique and offering supplemental patient management information.
4-04-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Disetronic Medical Systems, Inc. announced a voluntary nationwide recall of all ACCU-CHEK Ultraflex Infusion Sets because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event a full or partial separation occurs, insulin may leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia. The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain. Patients experiencing these symptoms are advised to check their blood glucose to ensure that the blood glucose level is within an acceptable range as defined by the patient's healthcare team and follow the medical advice given by the healthcare professional or contact their physician. Under this recall, customers have the option of replacing their ACCU-CHECK Ultraflex infusion sets, or using the ACCU-CHEK Tender or ACCU-CHEK Rapid-D infusion sets. For additional customer advice regarding this recall, please see the Disetronic Medical Systems, Inc. recall notice.
4-07-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Pfizer Pharmaceuticals notified healthcare professionals of important changes in the approved product labeling for Macugen (pegaptanib sodium injection), including changes to the CONTRAINDICATIONS, PRECAUTIONS, ADVERSE EVENTS Post-Marketing, and DOSAGE and ADMINISTRATION sections. Rare reports of anaphylaxis/anaphylactoid reactions, including angioedema following the administration of Macugen along with various medications administered as part of the injection preparation, were described. Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration, and is administered once every six weeks by intravitreous injection. Healthcare professionals should evaluate the patient's medical history for hypersensitivity reactions to Macugen prior to using this product.
4-11-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Fungal Keratitis Infections Related to Contact Lens Use Audience: Ophthalmologists, Optometrists, pharmacists, other healthcare practitioners, and consumers The FDA and CDC notified all healthcare practitioners and consumers of an increase in the number of reports in the United States of a rare but serious fungal infection of the eye in soft contact lens wearers. The infection, a fungal keratitis caused by the Fusarium fungus, may cause vision loss requiring corneal transplants. Both the FDA and CDC are investigating these occurrences. The CDC received reports of 109 cases of suspected fungal keratitis in 17 different States. Twenty-eight of the 30 cases reported wearing soft contact lenses. The majority of the individuals (26) reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection. Healthcare practitioners should refer patients presenting with a microbial keratitis immediately to an ophthalmologist for immediate treatment and report cases of fungal keratitis in contact lens wearers to FDA. Contact lens wearers should use good hygiene practices, e.g., wash hands with soap and water, and dry (lint free method) before handling lenses; wear and replace lenses according to the prescribed schedule; follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer; keep the contact lens case clean and replace every 3-6 months; and remove lens immediately if the wearer experiences symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.
4-17-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Boca Medical Products and FDA notified consumers and healthcare professionals of a recall of Ultilet Insulin Syringe 30g 1/2cc (Lot # - 5GEXI, NDC # - 08326-3002-50) because of possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR. For any question related to the case consumers should call 1-800-354-8460.
4-17-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Blackstone Medical, Inc. and FDA notified healthcare professionals about a recall of its ICON Modular Fixation System, a collection of components that allows the surgeon to assemble a construct including screws, connectors and rods. The construct is implanted in and near the patient's spine, and is intended to immobilize and stabilize spinal segments at the site of spine surgery. The recall was initiated because components in the system may fail after the devices have been implanted. The potential for injury due to failure of the implant will depend on the specific condition being treated, and the degree of postoperative healing. There may be potential for serious injury in specific patients. Blackstone Medical, Inc. is requesting that hospitals and surgeons review their records to identify patients who have the recalled products, and to contact these patients. Patients who may have concerns regarding their ICON fixation devices should contact the physician who is providing postoperative care.
4-18-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Ortho-Clinical Diagnostics and FDA notified healthcare professionals of a Class 1 recall of this reagent, a special chemical used with the VITROS Immunodiagnostic ECi/ECiQ System to screen patient samples and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B or C), thyroid disorders, HIV and pregnancy. A decreased signal in the reagent may produce inaccurate results in some cases, affecting the outcome of the diagnostic tests. Customers with the affected lot numbers should discontinue using any remaining reagent and should follow the enhanced Quality Control (QC) procedure provided by Ortho-Clinical Diagnostic for each pack in all lots of VITROS Signal Reagent until further notice. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results should discuss them with their physicians - cardiac disease, hepatitis (A,B, or C), thyroid disorders, HIV and pregnancy.
4-25-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and NIOSH (National Institute for Occupational Safety and Health) notified healthcare professionals that twelve incidents have been reported in which regulators used with oxygen cylinders have burned or exploded, in some cases injuring personnel. Some of the incidents occurred during emergency medical use or during routine equipment checks. FDA and NIOSH believe that improper use of gaskets/washers in these regulators was a major factor in both the ignition and severity of the fires, although there are likely other contributing factors. FDA and NIOSH recommend that plastic crush gaskets never be reused, as they may require additional torque to obtain the necessary seal with each subsequent use. This can deform the gasket, increasing the likelihood that oxygen will leak around the seal and ignite.
4-25-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor's advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.
4-28-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA is recommending that all healthcare providers take important safety steps when using the COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation. The COLLEAGUE pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for COLLEAGUE infusion pumps. In addition to the recommendations made by Baxter Healthcare Corporation when using the COLLEAGUE Volumetric Infusion Pump, FDA is strongly recommending the following measures: - Do not use the COLLEAGUE pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life threatening, if possible. - Have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available). - Monitor patients and check the pumps frequently. - Report any problems as soon as possible to Baxter and FDA. - Consider evaluating other options for infusion therapy if your facility relies primarily or entirely on COLLEAGUE Pumps. Other short-term options that may be appropriate for certain IV therapies include gravity drip and flow control devices (e.g., buretrol, volutrol, micro tubing, and flow control tubing devices). FDA is mindful of concerns about the availability of replacement units and is working with Baxter to resolve problems with the COLLEAGUE pump as quickly as possible.
4-28-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse Audience: Dentists, dental hygienists, and consumers Pascal Company, Inc. recalled all lots and all flavors of NeutraGard 0.05% Neutral Sodium Fluoride Anticavity Treatment Rinse and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse packaged in clear 160z plastic bottles. The products were recalled because they may be contaminated with Burkholderia cepacia and Pseudomonas aeruginosa bacteria. Burkholderia cepacia (B. cepacia) bacteria poses little medical risk to healthy people. However, the bacteria may affect individuals with certain health problems like a weakened immune system or chronic lung diseases, such as cystic fibrosis. The effects of B. cepacia range from no symptoms to serious respiratory infections, especially in patients with cystic fibrosis. Pseudomonas aeruginosa may cause urinary track infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients. Dental offices and consumers who have the product should discontinue use and destroy it or return the product to the place of purchase for further processing.
5-03-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and IVAX Pharmaceuticals, Inc. notified healthcare professionals of a recall of Goldline brand Extra Strength Genapap 500mg (Acetaminophen) Caplets and Tablets and Extra Strength Genebs 500mg (Acetaminophen) Caplets and Tablets due to a labeling error. Specifically, the product label should indicate that usage should not exceed 8 tablets or caplets in a 24 hour period. The erroneous label indicates not to exceed 12 tablets or caplets in a 24 hour period. In the event the maximum dosage of 8 tablets or caplets in a 24 hour period is exceeded, there may be an increased risk of acetaminophen toxicity to the liver, which may cause adverse health effects. There have been no reports of serious illness or injury relating to this labeling matter.
5-05-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers of reports of acute phosphate nephropathy, a type of acute renal failure, that is a rare, but serious adverse event associated with the use of oral sodium phosphates (OSP) for bowel cleansing. Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution (such as Fleet Phospho-soda or Fleet ACCU-PREP) and one patient who used OSP tablets (Visicol). Individuals at increased risk of acute phosphate nephropathy include: those of advanced age, those with kidney disease or decreased intravascular volume, and those using medicines that affect renal perfusion or function [diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly nonsteroidal anti-inflammatory drugs (NSAIDs)]. Recommendations were offered for providers and patients when choosing and using a bowel cleanser.
5-05-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Respironics and FDA notified healthcare professionals about the Class 1 recall of this device, a mechanical ventilator used to control or assist breathing. The ventilator is intended for home, institutional and portable settings and may be used for invasive as well as noninvasive ventilation. A design flaw can cause lead wires in the air flow valve to break during use. When this happens the ventilator stops providing mechanical ventilation. Customers should safely transition patients in their care from the PLV Continuum Ventilator onto other comparable patient support devices. If customers do not have a suitable ventilator to use for their patients, they should contact Respironics at 760-918-7328 to make suitable substitute arrangements.
5-12-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR. These labeling changes relate to adult patients, particularly those who are younger adults. A recent meta-analysis conducted of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24. It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.
5-19-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Spectrum Laboratory Products Tacrolimus Active Pharmaceutical Ingredient [API] Audience: Pharmacists and organ transplantation healthcare professionals Spectrum Laboratory Products and FDA notified healthcare professionals of the recall of the active pharmaceutical ingredient tacrolimus, an immunosuppressive drug used to prevent rejections of transplanted solid organs such as heart or kidney, after learning that some lots of the ingredient are subpotent. Spectrum tacrolimus API has been used by pharmacies for compounding purposes. The use of sub-potent tacrolimus in compounded drugs for transplant recipients may lead to sub-therapeutic tacrolimus blood levels and an unacceptable increased risk of solid organ transplant rejection. Patients receiving tacrolimus for solid organ transplant should not stop taking their medication, but rather should check with their physician or pharmacist. This recall does not apply to tacrolimus marketed in finished dosage form as Prograf(r) (Astellas Pharma, US) or to Prograf(r) oral capsules that have been used for compounding.
5-23-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Boca Medical Products and FDA notified consumers and healthcare professionals of an extension of an earlier recall of Ultilet insulin syringes and the additional recall of Closercare insulin syringes because of bacterial contamination with Paenibacillus. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. The recall includes Closercare Insulin Syringe 29g 1cc product lot number 5JCZ1 as displayed on the inner case and Ultilet Insulin Syringe 30g 1/2cc, product lot number 5KEO1 as displayed on the inner case. The earlier recall of Ultilet syringes included lot number 5GEXI. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR.
6-06-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of the resumed marketing, with a special restricted distribution program of Tysabri (natalizumab), a monoclonal antibody for the treatment of patients with relapsing forms of multiple sclerosis. Tysabri was initially approved by the FDA in November 2004, but was withdrawn by the manufacturer in February 2005 after three patients in the drug's clinical trials developed progressive multifocal leukoencephalopathy (PML), a serious viral infection of the brain. Tysabri will be available only through the Risk Management Plan, called the TOUCH Prescribing Program. In order to receive Tysabri, patients must talk to their doctor and understand the risks and benefits of Tysabri and agree to all of the instructions in the TOUCH Prescribing Program.
6-08-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. The FDA-approved labels recommends discontinuing the ACEI as soon as possible if a patient becomes pregnant. ACE inhibitor drugs are labeled pregnancy category C for the first trimester of pregnancy, and are labeled pregnancy category D during the second and third trimesters. Healthcare professionals should take these findings into consideration with other information about a patient's medical situation when prescribing ACE inhibitors. At this time, based on this one observational study, the FDA does not plan to change the pregnancy categories for ACE inhibitors. FDA will work with the Agency for Healthcare Quality and Research to identify other potential sources of data that will help determine the degree of risk associated with first trimester exposures to these drugs.
6-08-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals and consumers that it is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan, a gadolinium-containing contrast agent, and took the MRA test.
6-13-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Hamilton Medical, Inc. and FDA notified healthcare professionals of a recall of certain RAPHAEL model ventilators with older generation software, due to a software algorithm designed to suppress false positive alarms that may preclude any alarm (no visible or audible alarms are triggered).
6-16-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program MRL, Inc. and FDA notified healthcare professionals of a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators. An intermittent electrical connection within the device may result in failure or unacceptable delay in analyzing the patient's ECG, failure to deliver appropriate therapy and failure to resuscitate the patient. FDA defines a Class I recall as one in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
6-20-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novartis Consumer Health and FDA notified patients, pharmacists and other healthcare professionals that the sponsor is conducting a nationwide voluntary recall of all Triaminic Vapor Patch products due to reports of serious adverse events associated with accidental ingestion by children. Triaminic Vapor Patch is labeled as a cough suppressant for children two (2) years of age and older and is sold over the counter at pharmacies and retail outlets nationwide. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. FDA is warning consumers not to use the Triaminic Vapor Patch and is also advising consumers who have used the product and have concerns or questions to contact their physician or health care practitioner.
6-20-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued a Public Health Notification regarding the proper cleaning and sterilizing of reusable ultrasound biopsy transducer assemblies (i.e., transducer device and associated accessories). If these devices are not correctly reprocessed between patients, residual material from a previous patient may contaminate the biopsy needle and needle guide when the system is reused for biopsies. This could lead to patient infections. Therefore, the biopsy needle and its containing guide must always be sterilized. This should apply even if a sterile barrier sheath is used on the transducer assemblies during a biopsy procedure, as the sheath is compromised by the penetration of the needle. The Public Health Notification also provides recommendations for cleaning the devices.
6-26-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Sage Products and FDA notified healthcare professionals of a recall of specific lots of Comfort Shield Perineal Care Washcloths . Burkholderia cepacia can cause serious infections including pneumonia and bacterial sepsis in immuno-compromised persons, persons with cystic fibrosis (CF), in hospitalized patients in general as well as certain other patient groups. The product was distributed to hospitals, medical centers and long-term care facilities in the U.S. and Canada. There was no known distribution through retail sales.
6- 26-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Guidant and FDA notified healthcare professionals and patients that a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers and implantable cardioverter defibrillators [ICDs] is associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry or premature battery depletion. Patients with affected ICDs may experience inappropriate sensing or premature battery depletion. Physicians are asked to perform an exam as soon as possible to assess device function for all patients with implanted devices from this subset.
6-30-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The Food and Drug Administration notified healthcare professionals and patients that it completed its safety assessment of Ketek (telithromycin), indicated for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. The drug has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug. FDA determined that additional warnings are required and the manufacturer is revising the drug labeling to address this safety concern. FDA is advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems. Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function.
8-21-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and GlaxoSmithKline notified healthcare professionals of changes to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the prescribing information for Dexedrine (dextroamphetamine sulfate), approved for the treatment of Attention-Deficit Hyperactivity Disorder and narcolepsy. The warnings describe reports of sudden death in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
8-25-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Luitpold Pharmaceuticals, Inc. and FDA notified healthcare professionals of a voluntary recall of additional lots of Hydralazine HCl Injection (20 mg/mL, 1 mL single dose vials) because the products may contain particulates.
8-30-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA informed consumers and healthcare professionals that all dietary supplements containing ephedrine alkaloids are illegal to market in the United States. Dietary supplements containing ephedrine alkaloids, regardless of the dosage, are considered adulterated and pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure. FDA conducted an exhaustive evaluation of relevant scientific data evidence on ephedrine alkaloids before issuing this decision in a final rule in 2004. On August 17, 2006, a Court of Appeals ruling upheld this final rule, reversing an earlier decision by the District Court of Utah.
8-30-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Alaris Products notified healthcare professionals of a recall of defective infusion pumps due to a design defect called "key bounce" that may cause potential over-infusion of medications and result in an infusion rate at least 10 times the intended infusion rate. Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed once on the pump registers twice and not detected during programming verification. The products included in this recall (model numbers 7130,7131, 7230, and 7231) are distributed by Cardinal Health Care 303 Inc. The manufacturer provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected. Healthcare facilities can continue to use pumps in their possession, guided by the company's instructions.
8-31-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Steris and FDA notified hospital and long term care facility managers of a fire risk with use of Amsco Sonic Energy Cleaner and/or an Amsco Sonic Energy Console, used for cleaning reusable medical equipment. The affected products were manufactured from November 2000 until January 2005 bearing serial numbers 0432000018 to 0403105051. The location of the lid switch cable wiring harness in these units makes them susceptible to water damage to the electrical connections. If this occurs, it can cause overheating of the electrical system in the unit and lead to damage of the wiring harness(s) resulting in smoking, sparking, and fire. Healthcare professionals are instructed to follow proper safety precautions to prevent water from contacting the electrical wiring while using this device. A Steris technician will visit account holders to replace the wire harness and associated components of the affected units.
8-31-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals that human tissues recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. While no adverse reactions associated with these tissues have yet been reported, and subsequent processing should reduce the potential risks of infectious disease transmission, healthcare providers who were supplied with these tissues are being notified of the potentially increased risk for infectious disease transmission. FDA and the Centers for Disease Control and Prevention (CDC) are strongly recommending that healthcare providers inform their patients who received tissues initially recovered by DRS that they may have received tissue from donors for whom adequate donor eligibility determinations were not performed, and offer patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2, hepatitis B virus, hepatitis C virus, and syphilis. Further recommendations for testing are posted on the CDC website at: http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html. FDA will continue its investigation into this matter and will issue further public health updates, as needed.
9-07-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers of the seizure of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules distributed by Advantage Nutraceuticals, LLC, because the products, labeled as dietary supplements, are being promoted to treat serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia, and seizures. The products have not been shown to be safe and effective to treat these conditions and have not been approved by the FDA and are therefore in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act. FDA advises consumers who may be taking these products to consult their physicians.
9-20-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Ortho and FDA notified healthcare professionals and patients about revision to the prescribing information to inform them of the results of two separate epidemiology studies that evaluated the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different oral contraceptive. The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate. The second study found an approximate 2-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen. Although the results of the two studies differ, the results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women. Prescribing information for Ortho Evra continues to recommend that women with concerns or risk factors for thromboemboli disease talk with their healthcare professionals about using Ortho Evra versus other contraceptive options.
9-25-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Genentech and FDA notified healthcare professionals about revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information to inform healthcare professionals of 1] cases of a rare brain-capillary leak syndrome [reversible posterior leukoencephalopathy syndrome (RPLS)] and 2] postmarketing reports of nasal septum perforation. RPLS is a neurological disorder associated with hypertension, fluid retention and cytotoxic effects of immunosuppressive drugs on the vascular endothelium. The syndrome can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present, but is not necessary for diagnosis. The onset of symptoms has been reported to occur from 16 hours to 1 year after initiation of Avastin. Magnetic Resonance Imaging (MRI) is necessary to confirm the diagnosis of RPLS.
9-29-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA notified healthcare professionals and patients of new preliminary information from the North American Antiepileptic Drug Pregnancy Registry that suggests that babies exposed to Lamictal, indicated to treat seizures and bipolar disorder, during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. Women who are pregnant and taking Lamictal or who are thinking about taking this medication are urged to not start or stop taking the medication without first talking to their physician. More research is needed to be sure about the possibility of the increased chance of cleft lip or cleft palate developing in babies of pregnant women who take Lamictal.
9-29-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program [UPDATE 09/29/06 of original 2/8/06 alert] FDA held a public advisory committee meeting 9/21/06 to discuss the safety and overall risk-benefit profile for Trasylol. The committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database. On 9/27/06, Bayer told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. While FDA conducts its evaluation of this new safety study, it is recommended that physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks. Physicians should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report observed adverse event information to FDA's MedWatch program or Bayer.
10-06-2006 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential.
10-06-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Bristol-Myers Squibb notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a reorganization and highlighting of the current safety information to better inform providers and patients. The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.
10-14-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program LifeScan and FDA notified healthcare professionals and the public of counterfeit blood glucose test strips being sold in the United States for use with various models of the One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose. The counterfeit test strips potentially could give incorrect blood glucose values--either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death.
10-19-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Novartis and FDA notified healthcare professionals about revisions to the PRECAUTIONS section of the prescribing information, describing the occasional occurrence of severe congestive heart failure and left ventricular dysfunction in patients taking Gleevec. Most of the patients with reported cardiac events had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patients with signs or symptoms consistent with cardiac failure should be evaluated and treated.
10-20-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Roche Diagnostics and FDA informed consumers and healthcare professionals of the recall of CoaguChek PT test strips used to determine blood clotting time of patients taking anti-coagulant medication to prevent blood clots. The recall was due to the potential for a test strip defect that may cause falsely elevated test results, resulting in an incorrect dose of anti-coagulant medication or unnecessary corrective measures being taken to reduce the effect of circulating anti-coagulants. Healthcare professionals who use CoaguChek PT test strips should institute 'duplicate testing', or use two strips with different lot numbers, on each patient to reduce the risk of bias. Home users of CoaguChek PT test strip should immediately discontinue use of the product and contact their healthcare provider.
10-23-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and CDC updated an October 2005 alert to consumers and health care providers regarding reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135, manufactured by Sanofi Pasteur. To date a total of 15 confirmed cases of GBS among individuals 11-19 years of age occurring within six weeks of vaccination with Menactra have been reported to the Vaccine Adverse Event Reporting System (VAERS). Two additional cases have been confirmed in persons 20 years of age and older. All individuals are reported to be recovering or have recovered. While the cases reported suggest a small increased risk of GBS following immunization with Menactra, the limitations in VAERS, and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. At this time, CDC and FDA cannot determine with certainty whether Menactra does increase the risk of GBS in persons who receive the vaccine and, if so, to what degree. At the present time, there are no changes in recommendations for vaccination and individuals should continue to follow their doctors' recommendations. FDA asks any persons with knowledge of possible cases of GBS occurring after receiving Menactra to report them to VAERS at http://www.vaers.hhs.gov or by phone at 1-800-822-7967.
10-25-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Wyeth and FDA notified healthcare professionals of revisions to the OVERDOSAGE/Human Experience section of the prescribing information for Effexor (venlafaxine HCl), indicated for treatment of major depressive disorder. In postmarketing experience, there have been reports of overdose with venlafaxine, occurring predominantly in combination with alcohol and/or other drugs. Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcome compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Healthcare professionals are advised to prescribe Effexor and Effexor XR in the smallest quantity of capsules consistent with good patient management to reduce the risk of overdose.
10-25-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Heartland Repack Services and FDA notified healthcare professionals of a voluntary recall of all products containing a lot number beginning with "K" (example: K12345). Drugs repackaged by Heartland Repack Services are distributed through their own pharmacy services to Omnicare nursing homes and other institutional facilities. Omnicare is responsible for 1.4 million nursing home and healthcare patients in 47 states and Canada. These product lots are distributed in 30, 60, 90 count size boxes and 250 count bags. Both the boxes and bags contain unit dose strips of five tablets per strip. This recall was initiated because there is the potential for mislabeling and packaging mix-up. Due to incomplete accounting of product subject to this recall, on October 20, 2006 Heartland Repack Services issued a follow-up notice of the July 2006 recall.
11-13-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu, indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis of influenza in patients 1 year and older. There have been postmarketing reports, mostly from Japan, of self-injury and delirium with the use of Tamiflu in patients with influenza. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior.
11-17-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of a newly published clinical study showing that patients treated with an erythropoiesis-stimulating agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL are at a significantly increased risk for serious and life threatening cardiovascular complications, as compared to use of the ESA to target a hemoglobin concentration of 11.3 g/dL. The "Correction of Hemoglobin and Outcomes in Renal Insufficiency" study, published November 16, 2006 in the New England Journal of Medicine, reports the adverse cardiovascular complications as a composite of the occurrence of one of the following events: death, myocardial infarction, hospitalization for congestive heart failure, or stroke.
11-22-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Advanced Medical Optics, Inc. informed healthcare professionals and consumers of a nationwide recall of 18 lots of Complete (R) MoisturePLUS multipurpose contact lens care solution and Active Packs distributed in the United States. Certain lots were found to have bacterial contamination which compromised sterility. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis. Contact lens users who have the recalled product should discontinue use immediately and individuals who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.
11-27-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone's cardiac toxicities (QT prolongation and Torsades de Pointes). The reports underscore the importance of knowing methadone's toxicities and unique pharmacologic properties, including dosing and monitoring recommendations.
12-08-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals and consumers about the serious public health risks related to compounded topical anesthetic creams. FDA issued warning letters to five firms to stop compounding and distributing standardized versions of topical anesthetic creams, marketed for general distribution. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures, irregular heartbeats and death. Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors' offices.
12-08-06 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Baxter notified healthcare professionals of revisions to the WARNINGS section of the prescribing information for Heparin to inform clinicians of the possibility of delayed onset of heparin-induced thrombocytopenia (HIT), a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia and thrombosis (HITT). Thrombotic events may be the initial presentation for HITT which can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.
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FDA-MedWatch - The Food and Drug Administration
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