Merck will be presenting to an FDA advisory committee tomorrow in an effort to get their Statin drug Mevacor approved for over-the-counter. This is not the first time Merck has tried to get the drug approved for OTC.
From the Chicago Tribune:
Although other newer cholesterol drugs such as Lipitor, generic Zocor and others are considered more effective at lowering LDL, particularly those at high risk for a heart attack or stroke, Merck said Mevacor would be targeted for men and women at moderate risk of strokes and heart attacks. The company believes there are 20 million Americans who are at such moderate risk but only six million are currently being treated with statins.
But FDA panels have balked at an over-the-counter version of Mevacor in the past, worried that young people who dont need the drugs might take them under the influence of advertising. In addition, the drugs contain rare but still serious side effects such as muscle damage and liver toxicity side effects common to all statins.
A couple of big issues with this: A blood test and a doctor’s interpretation of a blood test are needed to properly diagnose good and bad cholesterol. A doctor also needs to take into account a person’s medical history and health status. And this move could also push patients to choose the “quick fix” route by taking a pill, instead of focusing on dietary or lifestyle changes, which could help to bring down their cholesterol.
The FDA rejected over the counter status for Mevacor back in 2005, so what’s changed?