Safety Alerts & Recalls

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FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and the Risk of Heart Attack, Sudden Death, and Stroke
The Food and Drug Administration (FDA) has issued an update in follow-up to the "FDA Drug Safety Communication: Ongoing Safety Review of Benicar (olmesartan) and Cardiovascular Events" announced in June 2010. This safety review looked at two research studies called, ROADMAP and ORIENT, in which patients with type 2 diabetes taking the blood pressure medication Benicar (olmesartan) had a higher rate of death from the heart-related events of heart attack, sudden death, or stroke compared to patients taking a placebo (inactive sugar pill). Other controlled clinical studies evaluating Benicar and medicines like it had not suggested an increased risk of death from heart attack, sudden death, or stroke. After reviewing the results of these two studies, the FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure as described in the prescribing information. Daiichi Sankyo, the makers of Benicar, have agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the heart-related risks and benefits of Benicar in different types of patients. FDA will update the public when new information is available. Benicar is an angiotensin II receptor blocker (ARB) used to treat high blood pressure. It contains the active ingredient olmesartan. Benicar is also sold in combination with hydrocholorothiazide as Benicar HCT and in combination with amolodipine (Norvasc) under the brand name Azor. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm251268.htm
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New Study: Too High a Dose of Thyroid Drug Raises Fracture Risk in Older Adults
In a study published in the British Medical Journal, researchers found that older people on medium to high doses of the thyroid medication levothyroxine were more likely to suffer a fracture than those on a low dose. This study looked at people aged 70 and over who had received at least one prescription for levothyroxine - the synthetic version of thyroxine - between 2002 and 2007. People with an underactive thyroid, or hypothyroidism, are usually prescribed levothyroxine, a synthetic form of the hormone thyroxine that is naturally secreted by the thyroid gland. Levothyroxine is sold under the brand names Levo-T, Levoxyl, Levothroid, Synthroid, Tirosint, and Unithroid. Natural thyroid hormone replacements are also available under the brand names Armour Thyroid, Nature-Throid, and Westhroid. For more information, please visit: http://www.bmj.com/content/342/bmj.d2238
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Date Published Title Drug Source
2011-04-29 FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and the Risk of Heart Attack, Sudden Death, and Stroke Olmesartan and Hydrochlorothiazide FDA
2011-04-29 New Study: Too High a Dose of Thyroid Drug Raises Fracture Risk in Older Adults Levothyroxine MediGuard CRT
2011-04-26 More Research Needed to Confirm Recent Study Results Showing That Anti-inflammatory Pain Medicines May Dampen Effect of Selective Serotonin Re-uptake Inhibitors (SSRIs) Paroxetine MediGuard CRT
2011-04-25 Mylan Pharmaceuticals Inc. Recalls Several Lots of Metformin Metformin FDA
2011-04-25 GlaxoSmithKline Inc. Recalls Select Lots of DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg Isradipine FDA
2011-04-25 Teva Pharmaceuticals USA, Inc. Recalls Select Lots of Topiramate Tablets, 25 mg Topiramate FDA
2011-04-25 Abbott Laboratories Recalls Several Lots of CREON (pancrelipase) Delayed Release Capsules, 6000 USP units Creon 20 FDA
2011-04-25 Lupin Pharmaceuticals Recalls Single Lot of Lisinopril Tablets, 30 mg Lisinopril FDA
2011-04-25 Centocor Ortho Biotech Recalls Single Lot of Simponi (golimumab), 50 mg/0.5 mL Golimumab FDA
2011-04-25 Teva Pharmaceuticals Recalls Single Lot of Gemfibrozil tablets, 600 mg Gemfibrozil FDA
2011-04-25 Novartis Pharmaceuticals Recalls Single Lot of Diovan (Valsartan) 160 mg Valsartan FDA
2011-04-25 Teva Pharmaceuticals Recalls Single Lot of Carvedilol Tablets, 12.5 mg Carvedilol FDA
2011-04-25 Teva Pharmaceuticals Recalls Three Lots of Pravastatin Sodium Tablets 20 mg and 40 mg Pravastatin FDA
2011-04-25 Teva Pharmaceuticals Recalls Single Lot of Zolpidem Tartrate tablets Zolpidem FDA
2011-04-25 Clot Risk May Be Higher With Newer Birth Control Pills Drospirenone with Ethinyl Estradiol MediGuard CRT
2011-04-25 FDA Issues Update on the Risk Of Progressive Multifocal Leukoencephalopathy With Tysabri Natalizumab FDA
2011-04-20 FDA Announces New Program for Long-Acting and Extended-Release Opioids Methadone FDA
2011-04-19 Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Can Clog, Block Oral Syringes and Feeding Tubes Lansoprazole FDA
2011-04-19 FDA Requires Manufacturers to Conduct Safety Studies for Long-Acting Beta-Agonists (LABAs) Mometasone and Formoterol FDA
2011-04-15 FDA Continues to Receive Reports of Rare Cancer in Patients Treated With TNF Blockers, Azathioprine, and/or Mercaptopurine Etanercept FDA