Merck will be presenting to an FDA advising board tomorrow in an effort to get their Statin drug Mevacor approved for over the counter. This is not the very first time Merck has tried to get the medication approved for OTC.
From the Chicago Tribune:
Although other newer cholesterol medications such as Lipitor, common Zocor and others are considered much more efficient at decreasing LDL, specifically those at high danger for a heart attack or stroke, Merck said Mevacor would be targeted for men and women at moderate risk of strokes and also cardiac arrest. The firm believes there are 20 million Americans that are at such “modest risk” but just six million are currently being treated with statins.
But FDA panels have actually stopped at an over the counter variation of Mevacor in the past, stressed that youths who do not require the medications might take them under the influence of marketing. Additionally, the medications include unusual yet still significant side effects such as muscle damage as well as liver toxicity– side effects typical to all statins.
A number of big issues with this: A blood examination and also a medical professional’s analysis of a blood test are required to correctly detect excellent and also negative cholesterol. A doctor additionally needs to take into account a person’s case history and also health condition. And this action can additionally push patients to pick the “quick fix” course by taking a tablet, rather than focusing on nutritional or lifestyle changes, which might help to lower their cholesterol.
The FDA rejected nonprescription standing for Mevacor back in 2005, so what’s transformed?