Safety Alerts & Recalls

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Latest Alerts

Serious Liver Disorder Associated with the Use of Didanosine (Marketed as Videx and Videx EC)
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using didanosine (also marketed as Videx and Videx EC). Non-cirrhotic portal hypertension occurs when blood flow in the major vein in the liver (the portal vein) slows down. This slowed blood flow can lead to the development of severely enlarged veins in the gastrointestinal system which sometimes leads to serious bleeding complications. The FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to the FDA's Adverse Event Reporting System (AERS). Based on these reports, the FDA has revised the didanosine, Videx, and Videx EC drug labels to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug. Didanosine is a medication used along with other drugs to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes AIDS. The brand name Videx was the first approved didanosine medication. Videx EC is a delayed-release version of Videx. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199169.htm#_Ref252375507
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Biogen Idec Announces Monthly Update of Tysabri Monitoring Program
Biogen Idec Inc. announced a new plan to communicate with doctors once a month on the occurrence of new cases of Progressive Multifocal Leukoencephalopathy (PML) in patients using its multiple sclerosis treatment Tysabri. PML is a rare but life threatening disease of the brain and nervous system. Under the new plan, Biogen will update doctors midmonth and provide information through a password- protected Web site. It will include the number of PML cases, with an incidence rate broken down by duration of Tysabri use. Patient services will provide Tysabri patients with information upon request, although not with the level of detail given to doctors. The reason for the difference between how doctors and patients are updated is because of government regulations that restrict direct interactions between patients and drug companies. For more information, please visit: http://online.wsj.com/article/SB10001424052748703415804575023493628662602.html.html#articleTabs%3Darticle
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Date Published Title Drug Source
2010-01-29 Serious Liver Disorder Associated with the Use of Didanosine (Marketed as Videx and Videx EC) Didanosine FDA
2010-01-29 Biogen Idec Announces Monthly Update of Tysabri Monitoring Program Natalizumab Manufacturer
2010-01-28 Recall of Several Lots of Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL Etanercept FDA
2010-01-28 Additional Recall on Milk of Magnesia: Mint Flavor and Original Flavor FDA
2010-01-27 Change to Prescribing Information for VELCADE to Include Dosage Adjustment in Liver Impairment Manufacturer
2010-01-26 Update on FDA Warning About Counterfeit Alli Orlistat FDA
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Glargine Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes NPH Insulin Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Glulisine Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Aspart Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Lispro Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Detemir Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Manufacturer
2010-01-21 Follow Up to FDA Ongoing Safety Review of SIBUTRAMINE, Marketed as MERIDIA Sibutramine FDA
2010-01-20 Endo Discontinues Making Moban (molindone hydrochloride) Moban Manufacturer
2010-01-18 FDA Warns Consumers About Counterfeit Alli Orlistat FDA
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Aspirin Manufacturer
2010-01-15 Voluntary Recall of Certain Lots of McNeil Over-the-Counter Products Rolaids Multi-Symptom Manufacturer