Friday, March 19, 2010

Zocor (simvastatin) has problems?

A few years ago, at an RWJ healthfair in Hamilton, New Jersey, a physician stated that statins should be placed in the water supply.

More recently, WebMD has a post titled FDA Warns of Zocor Risk to Muscles which includes the text:

A different study found that muscle damage was more common in patients taking Zocor doses of more than 20 milligrams a day who also took the heart rhythm drug amiodarone (brand names Cordarone, Pacerone). Patients taking another drug, verapamil (brand names Calan, Covera, Isoptin, Verelan), also should not take Zocor at doses higher than 20 milligrams .

And patients taking the angina/blood pressure drug diltiazem (brand names Cardizem, Cartia, Dilacor, Diltia, and Tiazac) were also at higher risk of muscle injury if they also took Zocor at doses higher than 40 milligrams a day.

New data also suggest that people of Chinese descent should not take Zocor at the 80 milligram dose -- and should be careful even when taking lower doses -- if they also take niacin-containing products.

You should never take Zocor at any dose if you are taking:

HIV protease inhibitors
You should never take more than the 10 milligram dose of Zocor if you are taking:


There was mention of warning symptoms:

Muscle Injury Symptoms Linked to Zocor, Other Statins
Symptoms of Zocor-related muscle damage include:

Muscle pain, tenderness, or weakness
Elevated blood levels of creatine kinase enzyme
Unexplained tiredness
Dark or red-colored urine

**from the FDA site:

In 2008, the agency alerted the public about an increased risk of developing rhabdomyolysis when doses greater than 20 mg of simvastatin are given with amiodarone. The agency also included information about this drug interaction in its Summer 2008 issue of the FDA Drug Safety Newsletter1 and in its November 2008 Patient Safety News broadcast2.

In March 2010, FDA approved a labeling revision for simvastatin based on interim results from an ongoing clinical trial – the Heart Protection Study 2 (HPS2). The revised label states 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.

Moreover, FDA has requested that the sponsor of simvastatin change the product labeling 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.

**The article did not mention the link between statins and transient global amnesia:

Do statins cause transient global amnesia?

**See also

Lipitor doesn't beat Zocor in heart attack study

The myth of the first-mover advantage

***UPDATE. August 2010-->

Bloomberg reports on a medical study arguing for a a justification for physicians NOT
to prescribe simvastatin (the ingredient of Merck's Zocor, which is now generic) over
Lipitor. There is no mention of "who" financed the study. From Bloomberg:

Researchers used a simulation to predict that 22 percent of patients taking a generic copy of Merck & Co.’s Zocor would develop heart disease during a 20-year period, compared to 20 percent of those on Lipitor, according an abstract of the study posted on the website of the European Society of Cardiology.

Doctors in the Netherlands have been required to justify prescribing brand-name cholesterol medicines since January 2009, the researchers from Pfizer and the University of Melbourne in Australia said. The study took into account that some patients were switched to the generic drug at a dose that wasn’t equivalent to the brand-name Pfizer cholesterol pill. Lipitor, the top-selling drug in the world, is set to lose patent protection next year.

Prescribing Lipitor is “sound from a health economic perspective,” the Dutch researchers said in the abstract.

The study will be presented at the European Society of Cardiology conference set to start next week in Stockholm.

See discussion in article by Slind-Flor: Merck, Pfizer, Apple, Madonna: Intellectual Property, which appears in a Bloomberg/BusinessWeek piece


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