SERIOUS WARNING ABOUT SIMVASTATIN (ZOCOR)

June 9, 2011

Here’s an important alert for patients taking the cholesterol-lowering drug simvastatin and for the people who care about them:

The 80-milligram (mg) dose of simvastatin is unsafe to use.

WorstPills.org has just classified this dose of simvastatin as a DO NOT USE medication.

But do not discontinue use of any medication without talking to your doctor first.

On June 8, 2011, the Food and Drug Administration (FDA) issued a safety announcement to health care professionals and consumers stating that patients taking a daily 80-mg dose of simvastatin have an increased risk of muscle injury (myopathy). In some patients, the myopathy progresses to a more serious disorder called rhabdomyolysis, which can damage the kidneys and lead to kidney failure and death.

We disagree with some of the FDA recommendations.

All doses of simvastatin, as well as all other statin drugs, carry a risk of myopathy, but this risk is particularly high with the 80-mg dose of simvastatin.

Symptoms of myopathy include weakness, muscle pain or tenderness, and fatigue. If the myopathy progresses to rhabdomyolysis, it can cause dark or red-colored urine.

Simvastatin is available as a single ingredient in generic form and under the brand name Zocor in doses of 10 mg, 20 mg, 40 mg and 80 mg. Simvastatin also is available in combination with other drugs under the brand names Vytorin (containing simvastatin in doses of up to 80 mg combined with ezetimibe) and Simcor (containing simvastatin in doses of up to 40 mg combined with extended-release niacin). The FDA has revised the labels for all these drugs.

The FDA has advised that health care professionals should:

• Maintain patients on 80-mg doses of simvastatin only if they have been taking this dose for 12 or more months without evidence of muscle injury;
• Refrain from starting new patients on 80-mg doses of simvastatin; and
• Place patients on a different drug if they do not meet their LDL-cholesterol goal using 40-mg doses of simvastatin.

We think this does not go far enough and that no patient should continue taking simvastatin at the 80-mg dose and that the FDA should ban this dose of simvastatin.

The FDA’s safety announcement also provides important new information about other drugs that can interact with simvastatin and increase the risk of myopathy and rhabdomyolysis, even at doses of 40 mg or lower. Patients should not take any dose of simvastatin while taking certain drugs, such as erythromycin, clarithromycin and ketoconazole. (See the complete table of contraindicated drugs near the end of the FDA safety announcement.)

Also, patients should not take more than the 10-mg dose of simvastatin while taking amiodarone, verapamil or diltiazem, and patients should not take more than the 20-mg dose while taking amlodipine or ranolazine.

Read the full FDA safety announcement.

What You Can Do
If you are currently taking simvastatin at an 80-mg dose, you should contact your health care provider as soon as possible to discuss changing to a lower dose of simvastatin or to a different drug. Do not switch to rosuvastatin (Crestor) because it also has an increased risk of rhabdomyolysis.

If you are taking simvastatin at any dose (or any other statin), contact your health care provider immediately if you develop muscle pain, tenderness or weakness, dark or red-colored urine, or unexplained tiredness.

If you are taking simvastatin at any dose, you should review your entire list of medications with your health care provider to assess whether you are taking other drugs that could increase your risk of myopathy because of adverse interactions with simvastatin.

Do not discontinue use of any medication without consulting your doctor first.

Report any adverse effects related to simvastatin to the FDA MedWatch program.