The FDA said today that it was informing the public about an increased risk for myopathy and rhabdomyolysis in patients taking simvastatin 80 mg. The warning is based on an ongoing review of the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial and other data.
Several items of note are also contained in the “Data Summary” section of the FDA Drug Safety Communication:
- Based on data from the HPS2 trial, the FDA recently approved a label change stating that “patients of Chinese descent should not receive simvastatin 80 mg with cholesterol-modifying doses of niacin-containing products. Further, the revised label recommends caution when such patients are treated with simvastatin 40 mg or less in combination with cholesterol-modifying doses of niacin-containing products. The interim HPS2 results showed that the incidence of myopathy was higher in patients of Chinese descent (0.43%) compared with patients not of Chinese descent (0.03%) taking 40 mg simvastatin plus cholesterol-modifying doses (≥1 g/day) of a niacin-containing product. It is not known if the increased risk for myopathy observed in these patients applies to other patients of Asian descent.”
- The FDA has requested a change in the simvastatin label “to instruct healthcare professionals to avoid prescribing simvastatin doses greater than 40 mg daily when patients are taking the medication diltiazem, due to an increased risk for myopathy.”
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” said Eric Colman, M.D., Deputy Director of FDA’s Division of Metabolism and Endocrinology Products (DMEP), in an FDA press release (below). “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”
The FDA listed the following limitations:
Do not use simvastatin with these medications:
- Itraconazole
- Ketoconazole
- Erythromycin
- Clarithromycin
- Telithromycin
- HIV protease inhibitors
- Nefazodone
Do not use more than 10mg of simvastatin with these medications:
- Gemfibrozil
- Cyclosporine
- Danazol
Do not use more than 20mg of simvastatin with these medications:
- Amiodarone
- Verapamil
Do not use more than 40mg of simvastatin with this medication:
- Diltiazem
Here is the FDA press release:
FDA NEWS RELEASE
For Immediate Release: March 19, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567; elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Warns about Increased Risk of Muscle Injury with Zocor
Highest approved dose of cholesterol-lowering medication could cause harm to muscles
The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. Although muscle injury (called myopathy) is a known side effect with all statins, today’s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug. Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” said Eric Colman, M.D., Deputy Director of FDA’s Division of Metabolism and Endocrinology Products (DMEP). “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”
Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Simcor.
FDA’s review of new information on the risk of muscle injury is derived from clinical trials, observational studies, adverse event reports, and prescription use data. The agency also is reviewing data from the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial, which evaluated major cardiovascular events, such as heart attack, revascularization and cardiovascular death, in patients taking 80 mg compared to 20 mg of simvastatin. SEARCH also included data on muscle injury in patients taking simvastatin.
FDA is committed to informing the public about its ongoing safety review of drugs and will update the public as soon as the review of simvastatin is complete.
For further information on this safety issue:
Ongoing Safety Review of High-dose Zocor (simvastatin) and Increased Risk of Muscle Injury
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