Statin drug may be approved for over the counter Posted by Liz at 12/12/07 02:29 PM

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 don’t 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?

comments (2)

1 Posted by Don McRell at 12/20/07 08:24 PM

I have a friend who has been taken ill, he has lost significant muscle mass, feels weak, and has developed neurological difficulties.He has been told that it could be attributed to his taking statins,which were prescribed for control of cholesterol. Further, reports fould on Google describe similar side effects including an unexpected rise in incidence of ALS-type illnesses associated with statins I'm suspicious about statins now, and since some of the side effects described above are also reported in the literature that comes with the drugs,I have stopped taking my prescription of Vytorin. It occurs to me that the rage about cholesterol could be in part generated by the manufacturers, to promote the products.The side-effects notwithstanding. It also occurs to me that nature provides us with cholesterol for reasons other than to merely clog our arteries. Am I not throwing out the baby with the bathwater when I try to reduce my cholesterol when it is not at a dangerous level? 3159016

2 Posted by Andreea at 04/03/08 08:37 AM

Can a drug treatment influence the number of leukocytes?