Safety Alerts & Recalls

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Latest Alerts

Early Research Results About Possible Safety Issue With Insulin Glargine (Lantus)
Diabetologia, the journal of the European Association for the Study of Diabetes (EASD), has just published a series of research papers that have examined a possible link between insulin glargine (Lantus) and the risk of being diagnosed with cancer. The results of the studies varied with some showing a link between insulin glargine (Lantus) and cancer, and some showing no link between insulin glargine (Lantus) and cancer. The authors concluded that additional research needs to be conducted on the issue. Insulin glargine, also known as Lantus insulin, is a member of the new class of insulin analogues used in the treatment of diabetes. It has a very similar structure to human insulin and provides a long-acting source of insulin to lower blood glucose in patients with diabetes. For more information, please visit: http://www.diabetologia-journal.org/cancer.html#info
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FDA Early Communication About Safety of Lantus (Insulin Glargine)
Following on from the Lantus (insulin glargine) safety alert we sent yesterday, today the FDA issued a Medwatch Alert in response to the use of Lantus and the possible risk for cancer in patients with diabetes. FDA is currently reviewing many sources of safety data for Lantus to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between the FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. The FDA will communicate the results for its ongoing review to the public as the review continues. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm169722.htm
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Date Published Title Drug Source
2009-06-30 Early Research Results About Possible Safety Issue With Insulin Glargine (Lantus) Insulin Glargine MediGuard CRT
2009-07-01 FDA Early Communication About Safety of Lantus (Insulin Glargine) Insulin Glargine FDA
2009-08-26 Recall of Two Lots of Accusure Insulin Syringes Insulin Glargine FDA
2009-10-28 Recall of All Accusure Insulin Syringes Insulin Glargine FDA
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Glargine Manufacturer
2011-01-16 The FDA Issues Drug Safety Communication: Update to Ongoing Safety Review of Lantus (Insulin Glargine) and Possible Risk of Cancer Insulin Glargine FDA
2012-02-02 Sanofi-aventis US, Inc. Recalls Several Lots of Lantus Insulin Glargine FDA
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Glulisine Manufacturer
2010-10-28 Sanofi-Aventis Recalls Single Lot of Apidra SoloStar Insulin Glulisine FDA
2011-10-20 Sanofi-Aventis Announces Shortage of Apidra SoloSTAR Pens Insulin Glulisine Manufacturer
2009-03-20 Insulin Pens and Insulin Cartridges Must Not Be Shared Insulin Lispro FDA
2009-08-26 Recall of Two Lots of Accusure Insulin Syringes Insulin Lispro FDA
2009-10-28 Recall of All Accusure Insulin Syringes Insulin Lispro FDA
2010-01-26 Recall of GlucoPro Insulin Syringes Insulin Lispro Manufacturer
2010-11-03 Discontinuation of Original Prefilled Pens for Humalog and Humalog Mix Insulin Lispro and Insulin Lispro Protamine Manufacturer
2013-04-19 One Touch Verio IQ and FreeStyle lnsulinx Blood Glucose Meters Recalled Insulin Lispro and Insulin Lispro Protamine FDA
2012-05-11 FDA Warns on Dangers of Unproven Treatment for Multiple Sclerosis Interferon Beta-1A FDA
2011-01-21 Bayer Informs Customers of Important Information About Alcohol Prep Pads in Betaseron Kits Interferon Beta-1B FDA
2011-02-01 Novartis Informs Customers of Important Information About Alcohol Prep Pads Packaged With Extavia Interferon beta-1b Kit FDA
2008-11-10 New Safety Information about Long-term Use of Ipratropium (Atrovent) for COPD Ipratropium MediGuard CRT
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