Safety Alerts & Recalls

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Latest Alerts

New Boxed Warning For Bupropion (marketed as Zyban, Wellbutrin, and generics)
The FDA announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the drugs used for smoking cessation, including bupropion (marketed as Zyban, Wellbutrin, and generics) and varenicline (marketed as Chantix). Bupropion currently has a Boxed Warning relating to an increased risk of suicidal thoughts and behavior when used in children and adolescents with depression. The new warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts and behavior when taking these drugs for smoking cessation. The FDA is also requiring the manufacturers of bupropion to update the Medication Guide to highlight these risks. Bupropion is approved for use in the treatment of depression, seasonal affect disorder, and as an aid to smoking cessation treatment. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm and http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm170356.htm
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FDA Takes Actions on Pain Medications Containing Propoxyphene
Based on a review of data submitted and available to the FDA, the FDA is acting on concerns about an increased risk of fatal overdose in patients who use medications that contain propoxyphene, a medication used to treat mild to moderate pain. Propoxyphene is a widely prescribed medication of a group of drugs known as opioids and is an ingredient in Darvon, Darvocet and other brands. The FDA is requiring the manufacturers of propoxyphene-containing products to strengthen the label's boxed warning to address the risk of overdose with these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed. The FDA will continue to work with manufacturers and other government agencies (including Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs (VA)) to conduct additional studies regarding the safety of products that contain propoxyphene as compared to other commonly used pain medications. The FDA will communicate its findings and will take appropriate regulatory action if needed. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm171714.htm and http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm
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Date Published Title Drug Source
2009-07-01 New Boxed Warning For Bupropion (marketed as Zyban, Wellbutrin, and generics) Bupropion FDA
2009-07-07 FDA Takes Actions on Pain Medications Containing Propoxyphene Propoxyphene HCl and Acetaminophen FDA
2009-07-10 Recall of a Single Lot of Sotret Isotretinoin Capsules, 40 mg Isotretinoin FDA
2009-07-10 Recall of Two Lots of Citalopram: One Lot of 10 mg Tablets and One Lot of 40 mg Tablets Citalopram FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Sirolimus FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Cyclosporine FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Mycophenolate FDA
2009-07-14 FDA Takes Actions on Pain Medications Containing Propoxyphene FDA
2009-07-16 Omalizumab (marketed as Xolair): Early FDA Communication about an Ongoing Safety Review Omalizumab FDA
2009-07-31 New Safety Information for Colchicine Colchicine FDA
2009-08-02 Several Lots of Caraco Brand Allopurinol 100 mg Tablets Recalled Allopurinol FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Rimabotulinumtoxinb FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Onabotulinumtoxina FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Abobotulinumtoxina FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Etanercept FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Adalimumab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Infliximab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Certolizumab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Golimumab FDA
2009-08-10 Recall of Single Lot of Watson Brand FENTANYL 100 mcg/hr Transdermal System Patches Fentanyl FDA