Safety Alerts & Recalls

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FDA Limits Use of 80 mg Simvastatin
The Food and Drug Administration (FDA) is placing limits on the use of medicine containing 80 mg of simvastatin—the highest approved dose of the popular cholesterol-lowering statin—because of the risk of muscle injury. The FDA says this high dose should only be used by patients who currently have been taking simivastatin 80 mg for 12 months or longer and have not experienced any muscle toxicity. Simvastatin 80 mg should not be prescribed to new patients. There are also new contraindications and dose limitations for when simvastatin is taken with certain other medications. All statins, despite their proven benefit in lowering the risk of heart attacks and strokes, carry some risk of an muscle injury called myopathy, which causes symptoms of unexplained muscle tenderness, weakness or pain. A very rare form of myopathy, called rhabdomyolysis, can lead to kidney failure and other serious problems. The risk of myopathy is greater for patients who take the 80 mg dose of simvastatin, especially in the first year of treatment. These muscle problems can also be caused by interactions with other medications and some people have a genetic predisposition toward simvastatin-related myopathy. Simvastatin is sold under the brand name Zocor and as a single-ingredient generic drug. It is also sold in combination with ezetimibe as Vytorin, and niacin as Simcor. The FDA has revised the drug labels for simvastatin, Vytorin, and Simcor products to include the new dose restrictions and to include dosing recommendations when these drugs are used with medicines that can increase the level of simvastatin in the body, thus increasing the risk of myopathy. For more information and to view a list of medicines that interact with simvastatin, please visit:  and and
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New Study Suggests High-Dose Statins May Cause Diabetes
A new study published in the Journal of the American Medical Association (JAMA) suggests that taking higher doses (80mg) of two types of widely prescribed statins - simvastatin or atorvastatin - increases the chance of developing Type 2 diabetes over five years, compared to taking moderate dose statins (20mg or 40mg). The researchers remain unclear about how statins work to trigger diabetes in some individuals. It could be possibly related to how statins affect muscle or liver insulin activity. Another explanation for increased diabetes in patients on high dose statin therapy may be because more patients at risk for diabetes are surviving due to the benefits of statins. More research is needed to confirm this study's findings. Atorvastatin is available under the brand name Lipitor and in the combination product Caduet. Simvastatin is available as a generic product, under the brand name Zocor, and in the combination products Simcor and Vytorin. For more information, please visit:
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Date Published Title Drug Source
2011-06-08 FDA Limits Use of 80 mg Simvastatin Simvastatin FDA
2011-06-30 New Study Suggests High-Dose Statins May Cause Diabetes Simvastatin MediGuard CRT
2011-08-16 Dr. Reddy's Laboratories Inc. Recalls Simvastatin Tablets Due To Musty Smell Simvastatin FDA
2011-12-15 FDA Revises Dose Limitation for Zocor (simvastatin) When Taken with Amiodarone Simvastatin FDA
2009-06-11 New Safety Information About the Use of Sirolimus (Rapamune) in LIVER Transplant Patients Sirolimus FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Sirolimus FDA
2010-01-15 Updated Information on Monitoring of Rapamune (Sirolimus) Drug Levels Sirolimus FDA
2009-09-25 New Information About Reports of Acute Pancreatitis in Patients Using Sitagliptan (Januvia, Janumet) Sitagliptin FDA
2013-03-15 FDA Studies Possible Pancreatic Risk With Class of Diabetes Drugs Sitagliptin FDA
2015-08-28 FDA Warns About Possible Side Effect of DPP-4 Inhibitors Sitagliptin FDA
2013-09-30 Combo-Medicine Juvisync Production Discontinued Sitagliptin and Simvastatin FDA
2008-08-05 Generic Manufacturer Recalls Several Drug Products Sodium Fluoride Manufacturer
2009-01-29 Recall on All ETHEX Brand Ethedent Chewable Tablets Sodium Fluoride Manufacturer
2010-11-04 Medical Products Laboratories, Inc. Recalls Single Lot of NaFrinse Sodium Fluoride FDA
2012-03-05 New Jersey CVS Pharmacy Dispenses Breast Cancer Medicine Instead of Kids' Fluoride Tablets Sodium Fluoride MediGuard CRT
2012-12-02 Church & Dwight Col, Inc. Recalls Single Lot of Orajel Kids My Way! Anticavity Fluoride Toothpaste Sodium Fluoride FDA
2012-12-17 FDA Warns Against Use of Xyrem With Alcohol, Insomnia Medicines, and Others Sodium Oxybate FDA
2008-12-12 New Boxed Warning for Oral Sodium Phosphate Bowel Cleansing Products Sodium Phosphate and Sodium Biphosphate FDA
2008-08-05 Generic Manufacturer Recalls Several Drug Products Soma Compound with Codeine Manufacturer
2009-02-01 Recall of Single Lot of Soma Compound Soma Compound with Codeine FDA
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