Panel Votes Against Wider Use of Drug
An FDA advisory panel Friday rejected 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.
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 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 -- was between 130 and 170 and who had at least one other risk factor for heart disease.
Among evidence against the change in status for the drug were mock pharmacy studies conducted by Merck showing that as many as 99% of potential patients 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 been 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 coughs and colds.
The petition to change Mevacor’s status was submitted by a joint venture of Merck and Johnson & Johnson designed to market over-the-counter versions of prescription drugs whose patents had expired. Merck’s lovastatin patent expired in 2001.
The panel’s recommendation was released before the close of the stock market. Merck shares ended the day up 22 cents to $30.87 in trading on the New York Stock Exchange. Johnson & Johnson gained 73 cents to $62.70 in NYSE trading.
