FDA Drug Safety Podcast for Healthcare Professionals: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On June 8, 2011, the Food and Drug Administration issued a Drug Safety Communication recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of myopathy. Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug. In addition to these new limitations, FDA is requiring changes to the simvastatin label to add new contraindications and dose limitations for using simvastatin with certain medicines.
Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. Patients with myopathy generally have muscle pain, tenderness or weakness, and an elevation of creatine kinase in the blood. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. Rhabdomyolysis is rare; hospitalized rhabdomyolysis occurs in 4.9 people out of every 100,000 people exposed to simvastatin for one full year. The average incidence for hospitalized rhabdomyolysis for atorvastatin, pravastatin, or simvastatin is 4.4 people out of every 100,000 people.
FDA has revised the drug labels for simvastatin and Vytorin to include the new dosing restriction for the 80-mg dose. The labels for simvastatin, Vytorin, and Simcor were also revised to include new dosing recommendations when these drugs are used with certain medicines that interact with simvastatin to increase the level of simvastatin in the body. Increasing the levels of simvastatin in the body can increase the risk for myopathy.
In March 2010, FDA announced it was reviewing the safety of simvastatin in the Agency's Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury.
At this time, FDA recommends that healthcare professionals should:
- Maintain patients on simvastatin 80 mg only if they have been taking this dose for 12 or more months without evidence of muscle toxicity.
- Not start new patients on simvastatin 80 mg.
- Place patients who do not meet their LDL cholesterol, or LDL-C, goal on simvastatin 40 mg on an alternative LDL-C lowering treatment that provides greater LDL-C lowering.
- Follow the recommendations in the simvastatin-containing medicines labels regarding drugs that may increase the risk for muscle injury when used with simvastatin.
- Switch patients who need to be initiated on a drug that interacts with simvastatin to an alternative statin with less potential for the drug-drug interaction.
- Report adverse events involving simvastatin-containing medicines to the FDA MedWatch program at www.fda.gov/medwatch.
Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Please read the Drug Safety Communication for the complete data summary and background information detailing this communication. A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety. If you have drug questions, you can reach us at email@example.com.
FDA Drug Safety Podcast for Healthcare Professionals: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury - mp3(MP3 - 7.6MB) [ARCHIVED] FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
FDA: Limit Use of 80 mg Simvastatin
FDA announces new safety recommendations for high-dose simvastatin[ARCHIVED]