Panel rejects OTC version of statin.(News)

BETHESDA, MD. -- Concerns about unintended pregnancy exposures and the ability of consumers to correctly select themselves for treatment without the advice of a health care professional were among those cited by Food and Drug Administration advisory panel members who voted against making low-dose lovastatin available over the counter.

At a joint meeting of the FDA's Nonprescription Drugs and Endocrinologic and Metabolic Drugs advisory committees last month, the panel voted 20-3 against recommending approval of the 20-mg dose of lovastatin for OTC use. Merck, which manufacturers lovastatin under the trade name Mevacor, has proposed that the daily 20-mg dose--at a retail price of about $1 per pill--be approved for OTC marketing for men aged 45 and older and women 55 and older who have a moderate risk for coronary heart disease (CHD), an LDL-cholesterol level of 130-170 mg/dL, and two risk factors.

Merck developed an OTC label to guide consumers in determining whether they are candidates for treatment, and conducted a large actual use study to simulate OTC use and a label comprehension study. This is the second time the company has requested an OTC switch for lovastatin: In 2000, the 10-mg dose was rejected by the advisory panels and FDA for OTC use because of safety and efficacy concerns.

One of the problems cited by panel members was that in the actual use study, about 41% of the users were women, but nearly 38% of these women were under age 55 and 22% were between the ages of 40 and 50 years, which includes women of childbearing potential. One panelist noted that with mass marketing, women younger than the target range would ultimately buy this medicine, and put themselves at risk. Most of the concern was with inadvertent exposure in the first trimester, in women who do not know they are pregnant.

Like all statins, lovastatin is labeled pregnancy category X because there are no well-controlled studies in pregnant women, and there have been some postmarketing reports of fetal adverse effects on live births in pregnancies with first-trimester exposure, as well as fetal and neonatal effects in animal studies, including skeletal anomalies at maternally toxic oral doses. This evidence would usually not result in a pregnancy contraindication for a drug, but because there is no benefit to temporarily treating hyperlipidemia during pregnancy, it is rated X.

The label proposed for OTC lovastatin includes a warning to pregnant or nursing women not to use the drug, but the panel generally agreed that this was inadequate. Merck officials at the meeting said they would be willing to work with the FDA to strengthen this message in the label.

The March of Dimes and the Organization of Teratology ...