FDA mulls availability of drug for cholesterol

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A Food and Drug Administration advisory panel is scheduled to recommend today whether a drug aimed at treating high cholesterol should be sold from store shelves like common remedies for headaches, colds and allergies.

Merck & Co. and Johnson & Johnson, in a joint venture, have asked the FDA to let them sell a low-dose version of cholesterol-lowering Mevacor directly to consumers.

During the first day of a two-day hearing yesterday at a Bethesda, Md., hotel, FDA drug advisers questioned whether the pharmaceutical companies compiled enough evidence of Mevacor's safety, such as for pregnant women.

"It seems to me the risk in humans has not been demonstrated," said Alastair Wood, chairman of the advisory committee.

He noted that some of the toxicity tests were performed on rats. In human trials, there were "several cases of adverse pregnancy," Dr. Wood said.

Potential problems include birth defects, he said.

Drug company officials said the risks were exaggerated at the 20 milligram dose that would be used for over-the-counter sales.

"We don't believe there's a significant risk at all," said Edwin Hemwall, vice president for Johnson & Johnson/Merck.

Nevertheless, the companies agreed to label the drug containers with warnings against use by pregnant women, high-risk heart patients, small children and people with liver disease.

They also said they would do "post-marketing surveillance" to monitor any adverse reactions from over-the-counter sales.