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FDA panel rejects OTC sale of drug

An FDA advisory panel rejected yesterday for the second time Merck & Co.'s bid to sell its cholesterol-lowering drug Mevacor to consumers without a prescription, citing the drug's risk of inducing birth defects and the need for patients to consult with a physician before embarking on a long-term drug regimen.

The Food and Drug Administration normally follows the recommendations of its advisory panels and seems likely to do so in this case, particularly since the vote among panel members was 20-3 against the drug.

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Mevacor, known generically as lovastatin, was the first member of the statin family to be approved and is generally considered one of the safest statins now available. Nonetheless, there is a substantial risk of birth defects if it is taken by a pregnant woman, a small risk of liver toxicity and an even smaller risk of muscle damage. When the drug is given by prescription, physicians normally order liver function tests to ensure that damage does not occur.

The proposed labeling for the over-the-counter drug would have said that it was meant for men over 45 and women over 55 whose level of low-density lipoprotein or LDL - the so-called bad cholesterol - is between 130 and 170 and who have at least one other risk factor for heart disease.

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One piece of evidence against the change in status for the drug was the mock pharmacy studies conducted by Merck showing that most potential patients - as many as 99 percent - who said they would buy and take the drug did not fit into those guidelines. Nineteen of the 24 panel members indicated that they found this disturbing.

The panel also concluded that patients taking any of the statin drugs should first undergo cholesterol screening and that they should have liver toxicity tests.

The risk to pregnant women or those who might become pregnant was also of great concern. Animal studies have shown a significant risk of birth defects, and at least seven deformed babies have been born to women taking the drug, the panel was told.

Had the change in status been approved, it would have marked the first time that a drug meant for long-term daily use had been given over-the-counter status. That status is now reserved for drugs used to treat short-term illnesses, such as colds.

The Los Angeles Times is a Tribune Publishing newspaper.


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