Mevacor Cannot Become Over-the-counter Medicine, FDA Advisory Panel Recommends

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Main Category: Statins
Also Included In: Regulatory Affairs / Drug Approvals;  Cholesterol;  Cardiovascular / Cardiology
Article Date: 14 Dec 2007 - 13:00 PDT

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Mevacor, a drug used for treating high cholesterol (a statin drug), should not change status from prescription only to over-the-counter (OTC), a Food and Drug Administration (FDA) panel recommended today. The Panel believes patients may not know how to use the drug correctly.

This is the third time that Mevacor makers, Merck & Co, apply for OTC status. This time round the Panel voted 10-2 against the move. Even though the Panel's decision is not binding, the FDA usually does what it recommends. The FDA will have the final say on 26th January, 2008.

Statins are the most commonly prescribed medications in the USA. In 2006 15 million Mevacor and generic versions of it were prescribed. According to the Panel, patients really do need to see a doctor who can decide whether their cholesterol levels are such that Mevacor should be used, and what the dosage should be.

Merck believes that by allowing people to buy the drug over-the-counter - without needing to get a prescription - millions of Americans with high cholesterol who are not being treated for it would benefit. The AMA (American Medical Association) does not agree that Mevacor should change status. There is concern that people who do not need statins might buy and consume Mevacor and suffer side-effects, such as muscle weakness and liver damage. There is also a risk that those whose cholesterol levels are slightly up may overmedicate themselves, while others whose cholesterol levels are very high may not be taking adequate doses.

On Merck's website, they made the following statement "We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription MEVACOR 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider," (statement made by - Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs, Merck & Co).

Sonia Caprio, a member of the Panel, said "I'm concerned we are going to have excess people who do not need the medication. There is going to be abuse.''

Mevacor - Full Prescribing Information (PDF)

Written by - Christian Nordqvist


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