Safety Alerts & Recalls

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Risk of Progressive Multifocal Leukoencephalopathy (PML) Increases with the Number of Tysabri (Natalizumab) Infusions Received
The FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. PML is a rare but serious brain infection associated with the use of Tysabri (natalizumab) and other medicines that control the immune system response. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Information about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who have developed PML and then stopped Tysabri has also been added to the drug label. IRIS is a rare condition that can occur after stopping immunosuppressant medications. During immune system recovery, patients can experience a severe inflammatory response to an infection and their symptoms can get worse, sometimes after a period of improvement. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199965.htm and http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199872.htm
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Voluntary Recall of Additional Lots of Sanofi Pasteur H1N1 Vaccine
Sanofi Pasteur is voluntarily recalling five lots of pediatric H1N1 influenza vaccine and one lot of H1N1 influenza vaccine for older children and adults given to prevent H1N1 influenza (often called "swine flu") because of a slight decrease in their potency that was detected during regular follow up testing. These vaccines were within potency specifications at the time of distribution. The recalled lots are UT023AA, UT023BA, UT023CA, UT023EA, UT023FA, packaged as 0.25 mL prefilled syringes in packs of 10 each and UT037AA, packaged as 0.5 mL prefilled syringes in 25-packs. These lots were shipped to healthcare providers between November 2009 and January 2010, according to CDC. The FDA and CDC have no concerns about the safety of these lots. This recall involves different lots than those recalled in December 2009. For more information, please visit: http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00306 In addition to the recalls, 14 previously distributed lots of 0.25-mL prefilled syringes containing Sanofi's H1N1 vaccine have been issued a shorter expiration period than indicated on the label. For more information about these lots with shortened expiration dates, please visit: http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00307
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Date Published Title Drug Source
2010-02-05 Risk of Progressive Multifocal Leukoencephalopathy (PML) Increases with the Number of Tysabri (Natalizumab) Infusions Received Natalizumab FDA
2010-02-03 Voluntary Recall of Additional Lots of Sanofi Pasteur H1N1 Vaccine Manufacturer
2010-02-02 Lilly Changes Zyprexa Prescribing Information for Indication for Use in Adolescents (Ages 13 to 17) Fluoxetine with Olanzapine Manufacturer
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