Drug Recalls and Alerts - 2004
 
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12/23/2004

FDA Issues Public Health Advisory Summarizing NSAID Risks

The United States Food and Drug Administration (FDA) has issued a Public Health Advisory summarizing recent recommendations concerning the use of nonsteroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. This advisory was issued because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events, such as heart attack or stroke (see eMedicine Recalls and Alerts 9/30/2004, 8/27/2004, 12/9/2004, and 12/17/2004).

Additionally, release of preliminary results from a long-term clinical trial which suggested that long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular risk compared to placebo (see eMedicine Recalls and Alerts 12/20/2004). The public health advisory is a temporary precaution, pending further review by the FDA of data that continue to be collected.

Find more information at FDA MedWatch.
 
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12/22/2004

Liver Toxicity Warning Added to Infliximab (Remicade) Prescribing Information

A new warning describing rare reports of liver toxicity associated with infliximab (Remicade, by Centocor). The liver toxicity may include acute liver failure, jaundice (yellowing of the skin and whites of eyes), hepatitis, and cholestasis. Some of these cases have caused death or required liver transplantation. Additionally, autoimmune hepatitis has been diagnosed in some of these cases. The onset of the liver toxicity typically occurred between two weeks to more than a year after infliximab initiation. Liver toxicity has been reported in approximately 3 patients in controlled clinical trials and 35 patients in voluntary postmarketing reported events. Approximately 576,000 patients have been treated with infliximab worldwide.

Patients should contact their physician immediately if signs or symptoms of liver toxicity appear. Signs and symptoms of liver toxicity may include the following:
  • Jaundice (yellowing of the skin or whites of the eyes)
  • Nausea
  • Vomiting
  • Abdominal pain
  • Elevated liver enzymes


Find more information at FDA MedWatch.
 
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12/20/2004

Study Halted Following Evidence of Increased Heart Risks with Naproxen (Aleve)

The National Institutes of Health (NIH) halted a clinical trial involving the nonsteroidal anti-inflammatory drug (NSAID) naproxen (Aleve, Naprosyn) due to preliminary information showing evidence of increased risk of cardiovascular events, such as heart attack or stroke.

The trial is known as the Alzheimer Disease Anti-Inflammatory Prevention Trial (ADAPT). The NIH has been studying the effects of naproxen (220 mg twice daily), celecoxib (Celebrex, 200 mg twice daily) and placebo (sugar pills) to assess the potential benefits to decrease the risk of developing Alzheimer Disease. The study specifically included people 70 years or older who were considered to be at increased risk because of family history, but did not have symptoms of the disease.

Although no significant increase in risk for celecoxib was found in this trial, the use of these drugs in the study was suspended in part because of findings reported last week from a National Cancer Institute (NCI) trial to test the effectiveness of celecoxib in preventing colon cancer (see eMedicine Alert 12/17/04). In addition, however, data from the ADAPT trial indicated an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen when compared with those on placebo.

The NIH and FDA will further review of the scientific data and advises patients currently taking naproxen to carefully follow the instructions on the label and not exceed the recommended dose (220 mg twice daily) and do not take for longer than 10 days, unless directed by your physician.

Find more information at FDA MedWatch.
For additional information:http://www.nih.gov/news/pr/dec2004/od-20.htm
 
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12/17/2004

Celecoxib (Celebrex) Investigational Trial Stopped Due to Increased Heart Attack Risk

A National Cancer Institute trial involving the COX-2 inhibitor celecoxib (Celebrex) has been halted after confirming an approximately 2.5- to 3.4-fold increase in fatal and nonfatal cardiac adverse events compared to individuals in the trial taking placebo (sugar pills). Patients in the trial taking 400 mg twice daily had a 3.4 times greater risk of cardiovascular events compared to placebo, whereas those taking 200 mg twice daily, the risk was 2.5 times greater. The investigational trial was examining the ability of celecoxib to prevent adenomas (tumors that grow from glandular tissue).

A similar study comparing celecoxib 400 mg once daily versus placebo has not shown an increased risk.

Other COX-2 inhibitors have been associated with increased cardiovascular events including myocardial infarction (heart attacks), including Vioxx which was removed from the worldwide market this fall (see Recalls and Alerts from September 30, 2004). More recently, the COX-2 inhibitor valdecoxib (Bextra) has strengthened warnings on not using the drug following heart vessel bypass surgery due to increased risk of heart attack and stroke (see Recalls and Alerts from December 9, 2004).

Find more information at FDA MedWatch.
 
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12/17/2004

New Warning for Liver Toxicity with Atomoxetine (Strattera)

Atomoxetine (Strattera), a drug indicated for attention deficit Hyperactivity disorder (ADHD) in adults and children, now carries a warning about the potential for severe liver injury. The labeling information is being updated with a bolded warning following two reports of patients who had been treated with atomoxetine for several months, and developed severe liver injury. Both patients recovered from the liver toxicity. The actual number of liver toxicity cases with atomoxetine is unknown because of under-reporting of post-marketing adverse events. The drug has been on the market since 2002 and has been used in more than 2 million people. In clinical trials of 6000 patients, no signs of liver injury occurred.

The warning describes the possibility that severe liver toxicity may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients.

Individuals taking atomoxetine who develop the following signs and symptoms of liver toxicity should contact their doctor immediately.
  • Jaundice (yellowing of the skin or whites of the eyes)
  • Pruritus (itchy skin)
  • Dark urine
  • Upper right-sided abdominal tenderness
  • Unexplained "flu-like" symptoms


Find more information at FDA MedWatch.
 
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12/17/2004

Gefitinib (Iressa) Shows No Survival Benefit for Lung Cancer

A large clinical trial comparing gefitinib (Iressa, by AstraZeneca) with placebo (sugar pills) showed no advantage in survival for non-small cell lung cancer. Patients currently taking gefitinib should consult with their doctor as soon as possible to determine an alternative therapy.

The United States Food and Drug Administration (FDA) approved gefitinib on May 2, 2003, under the accelerated approval program to treat nonsmall cell lung cancer who had failed two or more courses of chemotherapy. The accelerated approval regulations allow the FDA to approve a drug for marketing based on an effect that is considered reasonably likely to predict clinical benefit (improved symptoms or survival). Gefitinib was approved based on data from clinical trials showing tumor shrinkage in about 10 percent of patients, and improvement in symptoms in another 40%.

When accelerated approval occurs, the manufacturer is required to study the drug further after approval to verify the expected clinical benefit. After the 2003 approval of gefitinib, AstraZeneca conducted a study in 1700 patients to determine if the drug would indeed prolong survival. The study results indicate that the drug did not significantly prolong survival.

Find more information at FDA MedWatch.
 
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12/14/2004

Cardiac Reader System by Roche Recalled

Roche Diagnostics announced a recall for its Cardiac Reader System due to the potential for falsely decreased or false negative troponin T results and falsely decreased myoglobin results. The errors observed happened when the system would start the measuring process before the user applied the sample.

These tests are used as part of the diagnostic process for myocardial infarction (heart attack). Less than 100 health care facilities in the United States currently use the Cardiac Reader System. Roche Diagnostics is working with these facilities to determine the best alternative to measure troponin T and myoglobin results.

Find more information at FDA MedWatch.
 
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12/10/2004

Ventilator Recall Still Persists Due to Nonfunctioning Adaptor

The universal cable adaptor intended to correct an earlier Class I recall of LTV series ventilators is not functioning as intended (see previous eMedicine Recall from September 30, 2004). The adaptor may not allow the ventilator to be powered up again if the internal battery has been depleted or not securely attached to the pigtail connector on the ventilator. Over 1,000 adaptors have been distributed. The manufacturer has asked customers to remove the adaptors according to instructions provided to them and return the adaptors to the company. The ventilator manufacturer, Pulmonetic Systems, Inc. will replace the power circuit board for all affected LTV Series Ventilators.

A class I recall is issued when a drug or device may pose serious health risks to some users.

Find more information at FDA MedWatch.
 
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12/9/2004

Skin and Cardiovascular Risks Emphasized for Valdecoxib (Bextra)

Important new information on side effects associated with valdecoxib (Bextra, by Pfizer, Inc.), a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) has been announced by the United States Food and Drug Administration (FDA). Valdecoxib is indicated to treat osteoarthritis, rheumatoid arthritis, and dysmenorrhea (menstrual pain). A "boxed, bolded" warning has been added to the package insert emphasizing previous warnings about life-threatening skin reactions and contraindicating valdecoxib use for individuals who are undergoing coronary (heart) artery bypass graft (CABG) surgery.

Boxed and bolded warnings provide healthcare professionals and patients with important information on drugs that may be associated with serious side effects in order to maximize benefits and minimize drug risks.

Serious, potentially fatal skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. These reactions are most likely to occur in the first two weeks of treatment, but can occur any time during therapy. Valdecoxib should be discontinued at the first sign of skin rash, sores inside the mouth, or any sign of allergic reaction, such as swelling, itching, or shortness of breath. Other COX-2 (Vioxx, Celebrex) and traditional NSAIDs (Aleve, Motrin, Naprosyn) also have a risk for these rare, serious skin reactions, but the reported rate of the reactions appears to be greater for valdecoxib.

New data regarding cardiovascular risks is also highlighted that includes data from over 1500 patients treated after CABG. The patients treated with valdecoxib showed an increased cardiovascular risk compared to placebo. Observed cardiovascular events included myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (Blood clots in the leg), and pulmonary embolism (blood clots in the lungs).

Pfizer submitted the final report of the new CABG study to FDA on November 5, 2004. The report confirms the risk of the intravenous form (about 2 percent of patients had such an adverse event) and also shows that oral Bextra is associated with a lower, but some risk (about 1 percent of patients) immediately following CABG surgery. In the placebo group, about 0.5 percent of patients had an adverse cardiovascular event.

Find more information at FDA MedWatch.
 
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12/9/2004

Canadian Lithium (Carbolith) Recalled

The United States Food and Drug Association advised consumers about a Canadian recall of Carbolith (lithium carbonate) 150 mg capsules distributed in Canada by Valeant Canada Limited. Although Carbolith is not an FDA-approved product, several Internet websites exist that advertise Carbolith for sale to US consumers. Carbolith 150 mg capsules are used in the treatment of manic-depressive illness. Recent testing by the manufacturer concluded that Carbolith may not deliver adequate amounts of the drug to ensure effective treatment. Consumers who have taken Carbolith could experience poor control of their manic-depressive illness that is associated with lowered blood lithium levels. Consumers should contact their physician for further assessment and advice.

Find more information at FDA MedWatch.
 
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12/8/2004

Dose and Hemoglobin Target Levels Changed for Epoetin (Procrit)

Important changes have been made to the recommended monitoring and dosing of epoetin (Procrit, by Ortho Biotech Products). Changes to hemoglobin rate of rise and target. The goal of treatment (hemoglobin target level) should be individually determined for each patient. The dose should be interrupted and modified if hemoglobin increases at a rate exceeding 1 gram per deciliter over a 2-week period. The new prescribing information recommends that the target hemoglobin should not exceed 12 grams per deciliter for men or women.

The new recommendations result from recent investigational studies, some with erythropoietin products other than Procrit, and conducted outside of the US, where patients with cancer were treated to high hemoglobin target levels, beyond the correction of anemia. These studies permitted or required dosing to achieve hemoglobin levels of greater than 12 grams per deciliter. An increased frequency of adverse patient outcomes including increased mortality and thrombotic vascular events was reported in these studies.

Dosing recommendations for weekly administration are now FDA-approved. Previously, the only dosing regimen for cancer chemotherapy was 150 IU per kilogram subcutaneously (SC) three times per week. The revised dose allows for 40,000 IU SC once per week with the option for dosage adjustment after 4 weeks of treatment.

Find more information at FDA MedWatch.
 
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12/3/2004

Tosoh Bioscience Laboratory Software Recalled

The United States Food and Drug Administration (FDA) and Tosoh Bioscience, Inc. have issued a Class I recall of the Tosoh Bioscience AIA-600 II Enzyme Immunoassay Analyzer, software version 3.02. This laboratory analyzer is used by laboratory professionals to measure thyroid hormones, cardiac markers including troponin (an enzyme measure when a heart attack is suspected), tumor markers, as well as several other assays. The recall was prompted due to false positive and negative results. Erroneous laboratory results could lead to an improper diagnosis, a poorly controlled clinical conditions, treatment delays, and potentially death.

A class I recall is issued when a drug or device poses serious health risks or death to some users.

Find more information at FDA MedWatch.
 
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11/30/2004

Bicillin L-A for Syphilis Treatment

Penicillin G benzathine (Bicillin L-A) is the only currently approved penicillin G benzathine product indicated for the treatment of early syphilis. Other penicillin G benzathine products, such as Bicillin C-R (consisting of penicillin G benzathine combined with penicillin G procaine) is not considered appropriate treatment according to the Centers for Disease Control Sexually Transmitted Disease Guidelines and should not be administered in place of Bicillin L-A. Syphilis treated with Bicillin C-R instead of Bicillin L-A may result in inadequate treatment.

To assist healthcare professionals in distinguishing between the two types of Bicillin, the package for Bicillin C-R has been changed and includes a reminder statement on the package stating "NOT FOR THE TREATMENT OF SYPHILIS".

Additionally, a black box warning has been added to the prescribing information of both Bicillin products to call attention proper administration of these products by deep intramuscular (IM) injection. Penicillin G benzathine has caused cardiorespiratory arrest (heart attack) and death when inadvertently administered intravenous (IV).

Find more information at FDA MedWatch.
For additional information:http://www.cdc.gov/std/treatment/default.htm
 
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11/19/2004

Depo-Provera Injection for Birth Control and Bone Density

A "black box" warning will be added to the labeling of medroxyprogesterone (Depo-Provera Contraceptive Injection) that highlights the association between decreased bone density and prolonged use. The bone density loss may not be completely reversible after stopping Depo-Provera and is more likely with prolonged use (eg, greater than 2 years). Prolonged use should only be considered if other birth control methods are inadequate or contraindicated.

Bone mineral density should be evaluated when long-term Depo-Provera Contraception Injection is necessary. Loss of bone density during adolescence and early adulthood is a particular concern during this critical period of bone development. It is currently unknown if use during adolescence and early adulthood will reduce peak bone density and increase the risk for osteoporosis in later life.

Find more information at FDA MedWatch.
 
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11/19/2004

Class 1 Recall of Automatic External Defibrillator

A Class 1 recall has been issued for Access CardioSystems Automated External Defibrillators (AEDs). The Access AED is widely used to treat cardiac arrest (heart attack) by hospitals, fire departments and emergency medical services. An estimated10,000 devices are currently in service.

Serial numbers for the Access AEDs include:
  • 075690 to 077140, or
  • 175180 to 084760
The following described the problems reported with the Access AED:
  1. The AED may have a faulty circuit board that causes failure to deliver a shock
  2. The defibrillator may unexpectedly turn on, thereby causing the "on/off" switch to not operate properly and the AED unable to defibrillate
Customers should immediately stop using the recalled AEDs and replace the Access AEDs.

A class I recall is issued when a drug or device poses serious health risks or death to some users.

Find more information at FDA MedWatch.
 
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11/15/2004

Mifepristone (Mifeprex, RU-486) Warnings Strengthened for Serious Infections and Bleeding

Mifepristone (Mifeprex) is used to end early pregnancy (49 days or less since the onset of the menstrual cycle). Serious and sometimes fatal infections and bleeding occurs very rarely following spontaneous (miscarriage), surgical, and medical abortions, including following mifepristone use.

The new information reminds health care providers that serious bacterial infection and sepsis may occur without the usual signs of infection, such as fever and tenderness on examination. Health care providers should be aware that prolonged, heavy bleeding may warrant surgical interventions. It is also important for health care providers to consider the possibility of undiagnosed ectopic pregnancies (tubal pregnancies) as this condition may be missed by physical examination and ultrasound. Some of the symptoms of an ectopic pregnancy may mimic the expected symptoms of a medical termination of pregnancy, such as cramping, bleeding, dizziness, back pain, or nausea.

Patients should be advised to take their MEDICATION GUIDE with them if they visit an emergency room or another health care provider who did not prescribe Mifeprex, so that provider will be aware that the patient is undergoing a medical abortion.

Find more information at FDA MedWatch.
 
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11/8/2004

Revised Warnings for Adalimumab (Humira)

The United States Food and Drug Administration and Abbott Pharmaceuticals have notified healthcare professionals regarding revised warnings in the prescribing information for adalimumab (Humira). Adalimumab is a TNF-blocking drug indicated to treat rheumatoid arthritis.

The warnings include an increased risk of serious infection when combined with anakinra (Kineret), another TNF-blocking drug. The combination of adalimumab with other TNF-blocking drugs is not recommended.

Following the market release of adalimumab, reports have emerged describing anaphylaxis (serious allergic reaction) and blood adverse effects, such as pancytopenia, aplastic anemia, thrombocytopenia, and leukopenia.

Find more information at FDA MedWatch.
 
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11/4/2004

FDA Finds More Dietary Supplements Containing Sildenafil (Viagra)

The United States Food and Drug Administration (FDA) has issued a warning to consumers not to purchase or consume Actra-Rx or Yilishen. These products are promoted and offered for sale on Web sites as dietary supplements for erectile dysfunction and sexual enhancement in men and have been found to contain the prescription drug sildenafil (Viagra). The FDA has also issued an alert to stop importation of these products.

Sildenafil is the active ingredient of the prescription drug Viagra that is approved in the United States to treat erectile dysfunction. The FDA confirmed the chemical analysis of a study published that found each capsule of Actra-Rx contained prescription strength quantities of sildenafil.

Sildenafil is contraindicated with the use of organic nitrates in any form. The interaction may result in profound and life-threatening hypotension (low blood pressure) and increases myocardial infarction (heart attack) risk. Erectile dysfunction often occurs in patients with diabetes, hypertension, hyperlipidemia (high cholesterol), smokers, or ischemic heart disease. Nitrates may be prescribed to control the hyperlipidemia associated with the aforementioned conditions; thus, the risk for the serious drug interaction with sildenafil is probable.

Other dietary supplements have previously been found to contain sildenafil (see Recalls and Alerts 4/9/2003 and 5/23/2003).

Find more information at FDA MedWatch.
 
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10/26/2004

Medication Errors Reported with "Sound-alike" Names Reminyl and Amaryl

Confusion between similar sounding drug names may lead to miscommunication and errors. Recent reports describe confusing Reminyl (galantamine is the generic name), a drug used to treat Alzheimer disease, with Amaryl (glimepiride is the generic name), which is used to lower blood sugar in diabetes mellitus. These reports include instances in which Reminyl was prescribed, but Amaryl was incorrectly dispensed and administered instead, leading to various side effects including severe hypoglycemia (low blood sugar) and one death.

Spontaneous reports submitted to the United States Food and Drug Administration (FDA) and the United States Pharmacopoeia (USP) describe prescriptions that have been incorrectly written, interpreted, labeled, and/or filled due to the similar names. Adding to potential confusion, each product has an overlapping strength (4 mg) and both are available as tablets. The products also have generic names (galantamine, glimepiride) that may lead to alphabetical storage in close proximity.

It is important to note that Reminyl has a starting dosage of 4 mg twice a day, whereas Amaryl is initially dosed at 1-2 mg once a day, with a maximum starting dosage of 2 mg.

Although medication errors have multiple system causes, the following suggestions are intended to help decrease error potential:
  • For phone prescriptions, prescribers should spell out the name of the medication
  • For written prescriptions, prescribers should clearly print the name of the medication and add the intended indication
  • Pharmacists should place Amaryl and Reminyl apart from one another on the shelf and display "shelf talkers" (a visual description and warning regarding the similar names) for each drug at the storage locations
  • Pharmacists should confirm the brand name with the prescriber if unclear
  • Health care providers should counsel patients about the brand name, indication, and proper use of each drug


Find more information at FDA MedWatch.
 
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10/13/2004

Lymphoma Added to Infliximab (Remicade) Risks

Revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for the TNF alpha-blocking agent infliximab (Remicade) now include the risk for lymphoma. In controlled studies for TNF alpha-blockers, including infliximab, more cases of lymphoma have been observed in patients receiving TNF alpha-blockers than the control group. Infliximab is indicated to treat Crohn disease or rheumatoid arthritis. For patients with highly active disease and/or long-term exposure to immunosuppressant therapies, the risk of developing cancer may be higher, up to several times, that of the general population.

Find more information at FDA MedWatch.
 
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10/8/2004

Hepatitis B Virus Reactivation Associated with Rituximab

New information has been added to the WARNINGS section of the package insert for rituximab (Rituxan). Hepatitis B (HBV) virus reactivation presenting with fulminant hepatitis, hepatic failure, and death have been reported in some patients taking rituximab for hematologic malignancies. Screening individuals at high risk of HBV is needed before starting rituximab. HBV carriers should be closely monitored for clinical and laboratory signs of active HBV infection and hepatitis during and for several months following rituximab treatment.

If viral hepatitis develops, rituximab and any other chemotherapy should be discontinued and appropriate treatment, including antiviral therapy initiated.

Find more information at FDA MedWatch.
 
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10/6/2004

High Risk Patients Given Priority for Flu Shots Due to Anticipated Shortage

The remaining influenza vaccine supply (Fluzone, by Aventis Pasteur, Inc.) in the US is estimated to provide 54 million doses. Additionally, approximately 1.1 million doses of intranasal flu vaccine (FluMist, by MedImmune) will be available. However, the intranasal vaccine may only be administered to healthy persons 5-49 years of age and are not pregnant, including persons caring for children less than 6 months old, and health-care workers (with the exception of those who care for severely immune compromised patients in special care units, such as cancer units).

Because of the urgency of the situation, the CDC has issued the following recommendations to assure individuals at high risk of influenza complications have priority to receive the vaccine. In an average year, the flu causes 36,000 deaths (mostly in individuals 65 years or older) and 200,000 hospitalizations. Groups receiving priority include:

  • All children 6-23 months old
  • Adults 65 years or older
  • Individuals 2-65 years old with chronic medical conditions, such as heart disease, lung disease (including asthma), cancer, diabetes, kidney disease, anemias, or are immunosuppressed (including immune suppression causes by medications or AIDS)
  • Women who will be pregnant during the influenza season
  • Nursing home or long-term care facility residents
  • Children ages 6 months to 18 years on chronic aspirin therapy
  • Health-care workers involved in direct patient care
  • Home caregivers and household contacts of children younger than 6 months
Individuals not at high risk are asked to not receive the flu vaccine this season unless more vaccine becomes available.

For additional information:
http://www.hhs.gov/news/press/2004pres/20041005b.html
http://www.dhhs.gov/news/press/2004pres/20041005.html
 
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10/4/2004

Levoxyl May Cause Choking If Not Taken With Water

A warning regarding levothyroxine tablets (Levoxyl, by Jones Pharma Inc.) has been issued to remind patients to swallow the tablets with a full glass of water. Episodes of choking, gagging or the tablet becoming stuck in the throat have been reported. The reports have occurred predominately when Levoxyl tablets were not taken with water.

Levoxyl tablets may rapidly swell and begin to dissolve if taken without water or insufficient amounts of water. Most of the problems reported when swallowing the tablet disappeared when Levoxyl is taken with a full glass of water.

Find more information at FDA MedWatch.
 
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9/30/2004

Rofecoxib (Vioxx) Withdrawn from United States and Worldwide Market

Merck & Co., Inc. has announced that rofecoxib (Vioxx) will be withdrawn from the United States and worldwide market due to the association of rofecoxib with increased cardiovascular events (including heart attack and stroke). Rofecoxib is a prescription COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID) that was approved by the United States Food and Drug Administration (FDA) in May 1999. Rofecoxib is indicated to relieve symptoms of osteoarthritis, acute pain in adults, menstrual pain and symptoms, and to manage pain of rheumatoid arthritis in adults and children.

The decision to withdraw rofecoxib from the market was made after halting a long-term study of the drug due to an increased risk of serious cardiovascular events, including heart attacks and strokes. The APPROVe (Adenomatous Polyp Prevention on VIOXX) trial examined the ability of rofecoxib to decrease the risk of developing recurrent colon polyps when compared to placebo.

In June 2000, Merck submitted data from a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that compared rofecoxib to naproxen to determine if rofecoxib decreased gastrointestinal adverse effects, such as ulceration. During the study, an increased risk of serious cardiovascular events, including heart attacks and strokes, was observed in patients taking rofecoxib compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.

Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.

People taking rofecoxib should contact their physician to discuss discontinuing use of rofecoxib and plan for alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.

In addition, patients and health care professionals may obtain information from the website links below, or may call (888) 36-VIOXX (1-888-368-4699).

Find more information at FDA MedWatch.
For additional information:http://www.merck.com
 http://www.vioxx.com
 
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9/30/2004

Class I Recall of LTV Ventilators

A Class I recall has been issued for LTV series ventilators, models 1000, 950, 900, and 800 by Pulmonetic Systems, Inc. These ventilators are designed to automatically switch power to an internal battery operation, allowing uninterrupted ventilation if an external power source is removed or unable to power the ventilator. The ventilators have been found to malfunction when switching to the internal battery, causing failure of the ventilator to breathe for the patient.

Approximately 10,300 devices have been distributed in the United States and internationally. A Safety Alert has been sent to customers and users of the ventilators that provide instructions to provide ventilation in the event of a product malfunction. Pulmonetic will provide a permanent solution to customers and users within 4-6 weeks.

A class I recall is issued when a drug or device may pose serious health risks to some users.

Find more information at FDA MedWatch.
 
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9/30/2004

Zoledronic Acid (Zometa) Associated with Osteonecrosis of the Jaw

Cases of osteonecrosis (primarily involving the jaws) have been reported in patients treated with bisphosphonates including zoledronic acid (Zometa). The majority of the reported cases have been in patients undergoing dental procedures, such as tooth extraction, and also receiving cancer treatment including chemotherapy and corticosteroids. Osteonecrosis of the jaw (ONJ) has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies, such as chemotherapy, radiotherapy, and corticosteroids and additional conditions, such as anemia, blood clot disorders, infection, or pre-existing dental disease.

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with risk factors for osteonecrosis. While receiving treatment for cancer, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ.

Find more information at FDA MedWatch.
 
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9/3/2004

Class I Recall of Minerva Patient Lift

FDA and Medibo, Inc. notified healthcare professionals of a Class I recall of the Minerva Patient Lift (models ML-20 [49 units] and ML-30 [15 units]), a battery operated lift designed for lifting and transport of patients. The recall was issued because of three mechanical problems.
  1. The hanger bar may detach from the lift resulting in the patient falling to the ground because of a missing spring washer.
  2. A bolt in the foot pedal assembly may become loose causing the foot pedal assembly to fall off of the lift. This results in the lift becoming unstable and the patient possibly falling.
  3. Some units may have faulty actuator brackets on the mast assembly that can also cause the lift to become unstable.
Facilities should take the lifts out of service until they can be inspected by an authorized service engineer. A class I recall is issued when a drug or device poses serious health risks or death to some users.

Find more information at FDA MedWatch.
 
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8/27/2004

Expanded Evidence of Cardiac risk with Vioxx

A major Food and Drug Administration study of Vioxx have found that the risk of sudden cardiac death may increase up to three times among patients taking high doses of Vioxx, compared to that of patients who had not recently taken any form of pain killers. The report showed a 50% increase in heart attacks or sudden cardiac deaths among patients taking the standard starting dose of 12.5mg or 25mg of Vioxx compared to patients taking any dose of Celebrex. The report is the result of an analysis of medical records of 1.4 million people insured by Kaiser Permanente in Oakland California between 1999 and 2001. Note: Since the study is observational in nature, rather than randomized and controlled, it has limited implications.

 
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8/24/2004

Blood Abnormalities and Vasculitis Reported with Infliximab (Remicade)

Worldwide postmarketing reports describe infliximab (Remicade) causing blood dyscrasias (blood abnormalities) and vasculitis (an inflammation of the blood vessels). Cases of leukopenia (low white blood cells), neutropenia (low neutrophils, a particular type of white blood cells), thrombocytopenia (low platelets), and pancytopenia (decreased in many types of blood cells including red and white blood cells and platelets) have been reported. Some of the reports describe the toxicities resulting in death. Infliximab is a biological product indicated to treat rheumatoid arthritis and Crohn disease.

The blood abnormalities described above decrease the ability of the body to produce enough blood cells that help fight infections or help stop bleeding. Vasculitis may affect blood vessels in many parts of the body and results in changes in vision, weakness or arms and legs, and numbness or tingling in any part of the body. Individuals that develop symptoms of vasculitis (described above) or blood dyscrasias (a persistent fever, bruise or bleed very easily, or look very pale), should immediately seek medical care. Physicians should carefully determine whether infliximab treatment should be discontinued.

Find more information at FDA MedWatch.
 
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8/13/2004

Serious Thromboembolic Events Reported with Bevacizumab (Avastin)

The United States Food and Drug Administration (FDA) and Genentech, Inc. have issued a warning describing an increased risk of serious and fatal arterial thromboembolic events (ie, blood clots that develop in blood vessels) associated with bevacizumab (Avastin). The increased risk of thromboembolic events includes stroke, transient ischemic attacks (TIAs), angina (chest pain), and heart attack.

Risk of serious arterial thrombotic events was about twice as high (up to 5%) in patients receiving bevacizumab for colon or rectal cancer who also received 5-fluorouracil (5-FU).

Find more information at FDA MedWatch.
 
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7/21/2004

Troponin I Lab Test Recalled

A Class I recall has been issued for VITROS Troponin I Reagent Pack (by Ortho-Clinical Diagnostics). The test is used in the diagnosis of myocardial infarction to measure the cardiac enzyme troponin I in blood. Random occurrences of false positive test results have been observed, which may lead to unnecessary medical procedures.

Lots affected by the recall include: 1110, 1130, 2510, and 2530. Clinical laboratories should stop using the affected lots and contact health care providers who ordered the test.

A class I recall is issued when a drug or device poses serious health risks to some users.

Find more information at FDA MedWatch.
 
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7/14/2004

Paclitaxel-Eluting Coronary Stent (Taxus Express) Recalled

A Class I recall has been issued for a drug-eluting coronary stent (paclitaxel [Taxus Express]). Approximately 200 stents distributed nationwide with lot numbers 6294706 and 6365192 are affected. Stents in these two lots have failed to deflate causing impeded removal of the balloon after stent placement. Impeded balloon deflation may result in significant patient complications, including emergency coronary artery bypass graft surgery and death. Hospitals possessing affected lots should immediately discontinue use.

A class I recall is issued when a drug or device poses serious health risks to some users.

Find more information at FDA MedWatch.
 
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7/13/2004

Alenti Lift Hygiene Chair Recalled

A Class I recall has been issued for Alenti Lift Hygiene Chair (manufactured by Arjo, Inc.). The battery operated chair is designed to lift, move, and bath patients. In increased number of reports describe the lift tipping has resulted in serious injury. Lift instability on sloped floors, casters falling off during use, patients leaning of shifting, and not applying the brakes were cited as causes of the accidents.

Two models are affected by the recall: CDB8003-01 (without scale) and CDB8053-01 (with scale). This recall involves 885 Alenti patient lifts that have the potential to tip during use.

Additionally, the instructions do not properly state how to secure the patient while in the lift. Revised safety instructions have been provided to customers who have the chair. It is also advised to use the safety belt to secure the patient and provide better stability. Other patient lifts (see Recalls and Alerts March 11, 2004) have also been recently issued.

A class I recall is issued when a drug or device poses serious health risks to some users.

Find more information at FDA MedWatch.
 
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7/13/2004

Class I Recall Issued for VISULINK 532/U Eye Laser

VISULINK 532/U eye laser (manufactured by Carl Zeiss Meditec) is a medical device intended for use in laser treatment of diseases of the eye, particularly retinal detachments or retinal bleeding. The device has been recalled due to a faulty reflective coating of the mirror used to direct the laser treatment beam to the eye. The faulty mirror may misdirect the laser beam, potentially and cause damage to an unintended target, retinal bleeding, or burns.

A class I recall is issued when a drug or device poses serious health risks or death to some users.

Find more information at FDA MedWatch.
 
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6/28/2004

Antidepressant Use in Late Pregnancy Associated with Newborn Complications

Newborn infants exposed to certain types of antidepressants during the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications may be immediately apparent upon delivery.

The antidepressants associated with these adverse effects include serotonin/norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine (Effexor) or selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft).

Reported problems include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome.

Find more information at FDA MedWatch.
 
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6/22/2004

Close Monitoring of All Patients on Antidepressants Warranted

The United States Food and Drug Administration (FDA) encourages patients with depression and their families to watch for the onset of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsive behavior, akathisia (uncontrollable restlessness), mania, worsening of depression, or suicidal thoughts, especially early during antidepressant treatment. Any of these symptoms should be reported to the physician, especially if they are severe, abrupt in onset, or were not part of the depressive symptoms. Worsening of depressive symptoms and/or the emergence of suicidal thoughts or behavior may emerge whether or not they are taking antidepressant medications.

The following ten antidepressants have changed their package insert to reflect the need to carefully monitor patients (both adults and children) for worsening depression or suicidal behavior: fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), fluvoxamine (Luvox), citalopram (Celexa), escitalopram (Lexapro), bupropion (Wellbutrin), venlafaxine (Effexor), nefazodone (Serzone), and mirtazapine (Remeron).

Find more information at FDA MedWatch.
 
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6/10/2004

FDA Warns Against Domperidone Use While Breastfeeding

The United States Food and Drug Administration (FDA) warned healthcare professionals and breastfeeding women not to use the unapproved drug, domperidone, to increase milk production (lactation). The agency is concerned with the potential public health risks associated with domperidone, such as abnormal heart rhythms, heart attack, and sudden death. The FDA took these actions because it has become aware that some women are purchasing this drug from compounding pharmacies and from foreign sources. The FDA also issued letters to compounding pharmacies and suppliers of domperidone for use in compounding.

Although domperidone is approved in several countries outside the U.S. to treat certain gastric (stomach) disorders, it is not approved in any country, including the U.S., for enhancing breast milk production in lactating women and is also not approved in the U.S. for any indication.

Find more information at FDA MedWatch.
 
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6/9/2004

Muscle Toxicity Risk with Rosuvastatin (Crestor) Emphasized

The United States Food and Drug Administration (FDA) has issued an alert to remind patients taking the rosuvastatin (Crestor) to report myopathy (unexplained muscle pain and weakness) immediately to their doctor. Fever, dark urine, nausea, or vomiting may also occur with myopathy. The muscle pain or weakness could indicate a rare, but serious side effect called rhabdomyolysis. Rhabdomyolysis may cause kidney failure. Crestor is a prescription drug used to lower high cholesterol.

Individuals who are particularly at an increased risk include those 65 years or older, have decreased thyroid function, and/or kidney impairment. The risk for myopathy also increases with higher doses, especially at the highest approved dose of 40 mg per day. Increased rosuvastatin drug levels, which may increase toxicity risk are more common in Asians, or if the drugs cyclosporine (Sandimmune, Neoral) or gemfibrozil (Lopid) are also being taken.

Find more information at FDA MedWatch.
 
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5/20/2004

Paradigm Quick-Set Plus Insulin Administration Sets Recalled

The United States Food and Drug Administration (FDA) has issued a Class I recall for Paradigm Quick-Set Plus insulin infusion sets (manufactured by Medtronic MiniMed). Various device malfunctions causing insulin flow interruption to the patient prompted the recall. Complaints include bent cannulas, tubing occlusions, insertion site leaking, and infusion set dislodgement during removal. Adhesive failure, causing the device to detach from the skin has also been reported.

The recall applies to all Paradigm Quick-Set Plus models (MMT-359S6, MMT-359S9, MMT-359L6, and MMT-359L9) and all lot numbers.

Patients should discontinue using Paradigm Quick-Set Plus infusion sets as soon as they can obtain replacement units. Medtronics will provide free replacements via overnight delivery. Patients should call the 24-hour Help Line (Option 1) at 800-646-4633 (800 MINIMED) or contact the firm at www.minimed.com/QSP to exchange any unused infusion sets.

A class I recall is issued when a drug or device poses serious health risks to some users.

Find more information at FDA MedWatch.
For additional information:http://www.minimed.com/QSP/qsp.shtml
 
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5/12/2004

Adult Tylenol Capsules Found in Bottles of Motrin Grape Chewable Tablets

Bottles of Motrin Grape Chewable Tablets for children may contain adult strength Tylenol 8-Hour Extended-Release Geltabs. Use of the adult Tylenol product could provide more than the recommended dose (overdose) for children. Both products are manufactured by McNeil Pharmaceuticals.

The packaging error has been identified in Lot# JAM108 with an expiration date of January, 2006 (Exp 1/06). The manufacturing lot number and expiration date are embossed on the carton flap and printed on the bottle label.

The medications are visibly different. Motrin Grape Chewable Tablets are round, purple-colored, and have a line across the tablet with the letters MO and the number 50 on the tablet surface. The chewable tablets have a non-glossy finish and a grape smell. The Tylenol 8-Hour Geltabs are hard, round, gelatin coated and shiny. The geltabs are white on the one side, red on the other, with "8 Hour" printed in blue on either the red or the white side.

Anyone identifying a bottle included in this alert should contact the McNeil Consumer Relationship Center at 1-800-962-5357. If you suspect a child has taken Tylenol 8-Hour Geltabs, believing them to be Motrin Grape Chewable Tablets, contact their doctor or a poison control center immediately.

Find more information at FDA MedWatch.
 
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5/12/2004

Trazodone (Desyrel) Drug Interactions Revised

Information regarding drug interactions and the antidepressant drug trazodone (Desyrel) has been revised. When given with drugs that decrease trazodone metabolism, such as ketoconazole (Nizoral), ritonavir (Norvir), indinavir (Crixivan), a substantial increase in trazodone plasma concentrations may occur and result in toxicity.

Conversely, drugs known to speed up trazodone metabolism, such as carbamazepine (Tegretol) or rifampin (Rifadin) may decrease trazodone plasma concentrations.

Trazodone dose adjustments may be necessary when adding or discontinuing drugs that affect trazodone metabolism. When taking trazodone, it is important to talk to your doctor or pharmacist before beginning to take a new drug or stopping a drug you are currently taking.

Find more information at FDA MedWatch.
 
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5/10/2004

Oxandrolone (Oxandrin) Increases Bleeding Risk with Warfarin

The synthetic testosterone, oxandrolone (Oxandrin, by Savient Pharmaceuticals, Inc.) has been shown to cause unexpected large increases in the International Normalized Ratio (INR) or protime (PT) when concurrently administered with warfarin. The warfarin dose may need to be adjusted to decrease bleeding risk and keep the INR and PT within the desired range.

Individuals on warfarin who experience any bleeding or excessive bruising should contact their doctor immediately.

Find more information at FDA MedWatch.
 
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4/29/2004

New Warnings for Tegaserod (Zelnorm)

Tegaserod (Zelnorm) is used for short-term treatment of women with irritable bowel syndrome (IBS), whose most common bowel problem is constipation. Diarrhea is a common side effect. In most situations, individuals reported only a single diarrhea episode that typically occurred during the first week of treatment. Occasionally, individuals may experience severe diarrhea or ischemic colitis that may cause one or more of the following symptoms:
  • Lightheadedness
  • Dizziness
  • Fainting
  • New or worsening stomach pain
  • Blood in your stools or bleeding from your rectum
If any of these symptoms occur, stop taking tegaserod and call your doctor immediately.

Find more information at FDA MedWatch.
 
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4/21/2004

Medtronic Implantable Cardioverter Defibrillators Recalled

The United States Food and Drug Administration (FDA) has issued a Class I recall of Medtronic implantable cardioverter defibrillators (ICDs). The ICDs affected by the recall are the Micro Jewell II Model 7223Cx and GEM DR Model 7271. ICDs are surgically implanted mechanical devices used to shock the heart into normal rhythm after sensing a dangerously rapid heart rhythm.

These ICD models may have defective high voltage capacitors. The defective capacitors take longer than normal to charge near the end of the battery service life and may delay or not deliver the shock therapy. A total of 6268 of the affected ICDs were manufactured, an estimated 1800 are thought to be still implanted in patients worldwide.

Individuals with these Medtronic ICD models should contact their doctors for an evaluation of the ICD.

Class I recalls are the most serious type of recall and involve situations when a drug or device poses serious health risks or death to some users.

Find more information at FDA MedWatch.
 
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4/15/2004

Consumers Warned Regarding "Street Drug Alternatives"

The United States Food and Drug Administration (FDA) has issued a warning to consumers not to purchase or consume products marketed as "street drug alternatives" by Cytotec Solutions, Inc., of Tampa, Florida. FDA analysis of the products found the drugs diphenhydramine, dextromethorphan, ephedrine, and controlled substances, such as gamma butyrolactone (GBL) and gamma hydroxybutyric acid (GHB). Cytotec products have been sold on the Internet and in stores as legal versions of illicit street drugs.

Product names include Green Hornet, Trip2Night, Invigorate II, Snuffadelic, Liquid Speed, Solar Water, Orange Butterfly, and Schoomz. Labeling for these products lists a variety of herbal and other ingredients, but does not provide either the name of the manufacturer or the presence of the previously mentioned drug products.

Find more information at FDA MedWatch.
 
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4/9/2004

More Fentanyl (Duragesic) Patches Recalled

Janssen Pharmaceutica has expanded the Class I recall for fentanyl patches (Duragesic Transdermal System) to include additional lots. One fentanyl patch lot (DURAGESIC 75 mcg/hour patches, control number 0327192) was recalled in February 2004 (see eMedicine Recalls and Alerts February 20, 2004) due to a small percentage of patches in this lot potentially leaking medication along one edge.

The recall affects the following patches:

Control Number 0327192 (expiration date October, 2005)
Control Number 0327193 (expiration date October, 2005)
Control Number 0327294 (expiration date November, 2005)
Control Number 0327295 (expiration date November, 2005)
Control Number 0330362 (expiration date December, 2005)

A class I recall is issued when a drug or device poses serious health risks to some users.

Find more information at FDA MedWatch.
 
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3/26/2004

VITEK GPS-107 Gram Positive Susceptibility Cards Recalled

A class I recall has been issued for VITEK GPS-107 gram positive susceptibility cards (bioMerieux, Inc.). These cards are used with the VITEK Lab System in clinical laboratories to determine which antibiotic is best to use for the bacteria causing an infection. Some cards were stamped with an incorrect code causing the system to read and report incorrect results. The miscoded cards pose potentially life-threatening consequences due to inaccurate test results.

The recall affects lot M58X, catalog #V4368. A class I recall is issued when a drug or device poses serious health risks to some users.

Find more information at FDA MedWatch.
 
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3/26/2004

Nasal Spray Recalled Due to Contamination

Major Twice-A-Day 12 Hour Nasal Spray (Propharma, Inc., distributed by Major Pharmaceuticals) has been recalled due to contamination with Burkholderia cepacia bacteria. Use of the contaminated product has the potential for serious or life-threatening infections to develop in individuals with weakened immune systems, particularly individuals with cystic fibrosis.

The active ingredient in the product is oxymetazoline HCl 0.05%. The recall affects Lot #K4496 with an expiration date of October, 2006. The entire lot has been distributed nationwide to wholesalers, pharmacies, hospitals, and retailers. The product should be returned to its original place of purchase for a full refund.

Find more information at FDA MedWatch.
 
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3/22/2004

Atypical Antipsychotics and Risk of High Blood Sugar and Diabetes

The United States Food and Drug Administration (FDA) has asked all pharmaceutical manufacturers of atypical antipsychotics to add a warning statement regarding the increased risk of high blood sugar and diabetes in individuals taking these medications. Atypical antipsychotics include:

  • Aripiprazole (Abilify)
  • Clozapine (Clozaril)
  • Olanzapine (Zyprexa)
  • Quetiapine (Seroquel)
  • Risperidone (Risperdal)
  • Ziprasidone (Geodon)
Individuals with an established diagnosis of diabetes mellitus who take atypical antipsychotics should be monitored regularly for worsening of blood sugar control. People with risk factors for diabetes mellitus, such as obesity or family history of diabetes, who are starting treatment with atypical antipsychotics, should undergo fasting blood sugar testing at the beginning of treatment and periodically during treatment. Anyone treated with atypical antipsychotics should be monitored for symptoms of high blood sugar, including frequent thirst, frequent urination, increased hunger, and weakness.

Find more information at FDA MedWatch.
 
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3/11/2004

Faaborg Patient Lift Recalled Due to Bolt Failure

The United States Food and Drug Administration (FDA) issued a Class I recall of Faaborg battery operated patient lifts (distributed by Moving Solutions, Inc., Downers Grove, Illinois). Excessive wear and breakage of the main bolt that secures the lift arm to the lift frame may cause patients to fall resulting in injury or death. The FDA has received one report of death caused by failure of the main bolt. Facilities who utilize Faaborg patient lifts should stop using the lifts until the problem is corrected.

A class I recall is issued when a drug or device may pose serious health risks to some users.

Find more information at FDA MedWatch.
 
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2/20/2004

Fentanyl (Duragesic) Patches Recalled

The US Food and Drug Administration (FDA) has issued a class I recall for fentanyl transdermal system 75 mcg/h (Duragesic, by Janssen Pharmaceutica Products). The recall is due to the potential of the content leaking from the patch. Exposure to the leaked contents may cause an increased drug effect (eg, nausea, sedation, drowsiness, respiratory depression). Conversely, the leaked contents may result in inadequate pain control or withdrawal symptoms, such as sweating, insomnia, and stomach discomfort. If content leakage occurs, rinse exposed skin thoroughly with water only (do not use soap).

Patients or caregivers should immediately contact their physician or pharmacist for instructions about returning patches affected by this recall and obtaining a new supply.

The recall affects the following patches:
NDC #50458-035-05
Control number: 0327192; expiration date: October 2005

A class I recall is issued when a drug or device poses serious health risks to some users.

Find more information at FDA MedWatch.
 
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2/12/2004

More Foreign Websites Found Selling Counterfeit Birth Control Patches

The US Food and Drug Administration (FDA) has taken action against 3 more foreign Internet sites selling counterfeit contraceptive patches that contain no active ingredients. Refer to eMedicine Drug Recalls and Alerts 2/6/2004.

These counterfeit patches do not provide protection against pregnancy. To protect the public, the FDA has obtained the cooperation of the United States-based Internet service provider to discontinue service to these sites.

Consumers are encouraged to fill prescriptions at reputable pharmacies. Those seeking to buy safe and effective drugs via the Internet should only purchase from Internet sites bearing the Verified Internet Pharmacy Practice Sites (VIPPS) seal showing that they are in accordance with the National Boards of Pharmacy standards.

Find more information at FDA MedWatch.
 
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2/6/2004

Counterfeit Contraceptive Patches Discovered

An overseas Internet site has been selling counterfeit contraceptive patches promoted as Ortho Evra transdermal patches that contain no active ingredients.

The US Food and Drug Administration (FDA) and Johnson and Johnson Co. of Raritan, NJ (manufacturer of the FDA-approved Ortho Evra contraceptive patches) have issued a public warning that the counterfeit contraceptive patches provide no protection against pregnancy. Consumers who have any of these products should not use them, but instead contact their healthcare providers immediately.

More information regarding the Internet site that is selling the counterfeit patches is available atprovided in the link provided below to the official FDA Talk Paper.

Find more information at FDA MedWatch.
 
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2/2/2004

Risk for Liver Toxicity by Nevirapine (Viramune) Emphasized

Liver toxicity may occur with nevirapine (Viramune) treatment, particularly within the first 6 weeks of treatment. Although the greatest risk is within the first 6 weeks of initiating nevirapine, the risk continues beyond this time period.

Individuals must have blood drawn before Viramune is started and periodically while taking the drug to check for evidence of liver damage. Symptoms may include severe skin rash, fatigue, poor appetite, nausea, jaundice (yellow-tinged skin or eyes), liver tenderness or enlargement. If any of these symptoms occurs, immediate medical attention is necessary.

Women with higher CD4 counts (above 250 cells/mm3), including pregnant women receiving long-term treatment, are at a much higher risk (12-fold) to develop liver toxicity.

Find more information at FDA MedWatch.
 
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1/27/2004

Education Campaign Provides Safe Use Tips on OTC Drugs for Pain and Fever

A national education campaign to provide advice on the safe use of over-the-counter (OTC) pain and fever reducers has been initiated. The information focuses on drugs containing acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). Acetaminophen may cause liver toxicity when used for prolonged periods of time or at doses exceeding 4 grams per day. NSAIDs may cause gastrointestinal bleeding and kidney toxicity. The campaign is intended to raise consumer awareness regarding these safety issues and to inform healthcare providers about the role that they can play in preventing toxicity.

Find more information at FDA MedWatch.
 
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1/19/2004

Topiramate (Topamax) Causes Metabolic Acidosis

Topiramate (Topamax, by Ortho-McNeil) causes metabolic acidosis (decreased serum bicarbonate). Periodic blood measurement to check bicarbonate during topiramate treatment is recommended.

Metabolic acidosis may cause hyperventilation, as well as nonspecific symptoms, such as fatigue and anorexia. More severe adverse effects include abnormal heart rhythm or stupor (impaired reaction time and decreased consciousness). Chronic, untreated metabolic acidosis may increase the likelihood of kidney stones, osteomalacia (rickets in pediatric patients), or osteoporosis with an increased risk for bone fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates.

Find more information at FDA MedWatch.
 
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1/19/2004

Oseltamivir (Tamiflu) Not for Children Under 1 Year

Oseltamivir (Tamiflu, by Roche Pharmaceuticals) is a treatment given to individuals with influenza (seasonal flu) to shorten the duration and decrease the severity of flu symptoms. It is most effective in people who have experienced flu symptoms for less than 2 days. Oseltamivir has been well tolerated in treating children as young as 1-year-old; however, findings in young rats have raised possible concerns regarding the use of oseltamivir in infants less than 1 year of age.

Death resulted in 7-day-old rats following a single oseltamivir dose that equaled about 250 times the recommended dose in children. Further studies showed oseltamivir brain levels to be 1500 times those seen in adult animals. Studies showed no deaths or other significant effects in older rats given the same or higher doses. The significance of these findings to human infants is uncertain. Because of this uncertainty in predicting the exposures in infants, oseltamivir should not be administered to children younger than 1 year.

Find more information at FDA MedWatch.
 
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