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Recalls & Warnings Antiviral Drug Labels Get Warnings for Neuropsychiatric Changes
Patients with influenza should be closely monitored for signs of abnormal behavior during treatment with Tamiflu and possibly also Relenza.
March 2008
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Recalls & Warnings FDA Cautions Against Swallowing Tiotropium and Formoterol Capsules
Tiotropium bromide (Spiriva) and formoterol fumarate (Foradil) capsules contain inhalation powder for delivery to the lungs and should only be administered through an inhalation device.
February 2008
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Recalls & Warnings Baxter Recalls All Remaining Heparin Vial Products
Baxter International is now recalling from the market all remaining lots and doses of its heparin sodium multidose and single-dose vials for injection and its heparin lock flush solutions.
February 2008
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Recalls & Warnings Natalizumab May Cause Significant Liver Injury
Natalizumab (Tysabri) should be discontinued in patients with jaundice or other signs of liver injury.
February 2008
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Recalls & Warnings Fold-Over Defect Causes Another Recall of Fentanyl Pain Patches
This time from Actavis, which has initiated a recall of 14 lots; direct exposure to fentanyl gel may lead to potentially fatal adverse events.
February 2008
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Recalls & Warnings Fentanyl Gel Patches Recalled Due to Manufacturing Defect
A cut edge in the drug reservoir may lead to direct exposure to fentanyl gel (Duragesic) resulting in potentially fatal adverse events.
February 2008
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Recalls & Warnings Problems With Baxter Heparin Still Unresolved
Because of continuing severe adverse reactions, Baxter has stopped manufacturing multiple-dose vials of heparin. The FDA is recommending that heparin manufactured by other companies or alternative anticoagulants be used if possible.
February 2008
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Recalls & Warnings Respiratory Compromise, Death May Be Linked to Botulinum Toxin
An ongoing FDA safety review of Botox, Botox Cosmetic (botulinum toxin type A), and Myobloc (botulinum toxin type B) has shown systemic adverse reactions resembling botulism.
February 2008
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Recalls & Warnings FDA Takes Action to Stop Marketing of Unapproved Colchicine Injection
The US Food and Drug Administration has received 50 reports of adverse events with colchicine injection, including 23 deaths, related to product use.
February 2008
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Recalls & Warnings Varenicline May Be Linked to Risk for Serious Neuropsychiatric Symptoms
Patients given varenicline should be monitored for strange thoughts/behaviors, depressed mood, and suicidality.
February 2008
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Recalls & Warnings Antiepileptic Drugs Linked to Increased Risk for Suicidality
Patients taking certain drugs for epilepsy or other indications should be carefully monitored for behavioral changes.
February 2008
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Recalls & Warnings NuCel Labs Issues Voluntary Recall for Eye Drops and Eye/Ear Washes
FDA testing reveals bacterial contamination and potential risk for eye infections.
January 2008
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Recalls & Warnings Pediatric Deaths From Influenza/MRSA Coinfection Spark CDC Advisory
Healthcare professionals should be aware of the increased rate of bacterial coinfection in influenza patients.
January 2008
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Recalls & Warnings Urgent CDC Bulletin Alerts Neurologists to Symptoms in Pork Workers
Prompted by reports of neurological symptoms among workers at 2 pork processing plants in the United States, the Centers for Disease Control and Prevention has dispatched an urgent bulletin to all US neurologists requesting information about any similar cases they may come across.
January 2008
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Recalls & Warnings Baxter Recalls Heparin
Nine lots of the antithrombin have been recalled because of a higher-than-expected rate of allergic reactions.
January 2008
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Recalls & Warnings Class 1 Recall for Cordis Fire Star, Dura Star Balloon Catheters
Cordis is recalling certain lots of its recently introduced Fire Star RX and Dura Star RX coronary balloon catheters due to a risk of slow or low deflation.
January 2008
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Recalls & Warnings Sargramostim Liquid Injection Withdrawn From US Market
The edetate disodium component of Leukine has been linked to increased reports of adverse reactions, including syncope.
January 2008
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Recalls & Warnings VTE Warning for Contraceptive Patch
The US FDA has updated the labeling for the Ortho Evra patch to include the results of a new study suggesting that it is associated with a higher risk of venous thromboembolism than oral contraceptive pills.
January 2008
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Recalls & Warnings Potential Contamination Prompts Urgent Recall of Heparin and Saline Flushes
Apparent lack of compliance with quality control regulations leads to expansion of former recall.
January 2008
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Recalls & Warnings FDA Warns Against Use of OTC Cough/Cold Products in Young Children
Over-the-counter cough and cold products have not been shown to be safe or effective in children younger than age 2 years, the agency says.
January 2008
