FDA Panel says 'NO' to making Mavocor an OTC drug

Main Category: Statins
Article Date: 15 Jan 2005 - 10:00 PDT


An FDA advisory panel said 'no' to Merck's request that its statin, Mevacor, become an OTC (over-the-counter) drug. The panel voted 20 against and 3 in favour of the request. What the advisory panel recommends is usually accepted by the FDA.

Mevacor is a statin - a drug people take to lower their cholesterol levels. The drug is generally taken over the long term.

Merck wanted the drug to be available for people without a prescription.

The panel was concerned that some people may not take the drug in the correct doses, they were also concerned about pregnant women taking the statin. The drug does have side effects, even though they are rare (muscle damage).

The panel concluded that the manufacturer, Merck, had not convinced them that all of the general public would use the drug appropriately if it were available without a prescription.

The same request had been made in 2000 when it was also turned down.

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