Considering the actual use study, most of the panel said that while they agreed that the 20-mg dose was safe and effective, the results did not support the conclusion that the dose could safely and effectively be used in an OTC setting because of self-selection issues and the behavior of users after starting treatment. A large proportion of people in that study relied on a physician's advice for correctly self-selecting or self-diagnosing their need for a 20-mg dose, and most of the panel said that once OTC lovastatin was available, they would not expect consumers would have this much interaction with health care professionals about using it.
Furthermore, panelists generally agreed that the warning on the proposed label stating that the drug should not be used if pregnant or breast-feeding was inadequate. In the actual use study, nearly 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, the FDA reviewer pointed out.
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.
Although lovastatin is available in generic form, if approved for OTC use, Merck would have exclusive rights to market it for 3 years. In December, Bristol-Myers Squibb announced plans to pursue approval of the 20-mg pravastatin (Pravachol) dose as an OTC treatment.
The vast majority of at-risk patients are receiving no therapy right now and should be, said panel chair Dr. Alastair Wood. James Reinaker