Email this article to a friend

Printable Version

Articles Related to This Article: • Merck litigation strategy - destroy expert witnesses • Leaked documents show Merck knew of Vioxx dangers, yet hid them for years • Merck Caught in Massive Scientific Fraud as In-House Authors were Disguised as Independent Scientists (opinion) Support NaturalNews advertisers - Advertise with NaturalNews Nutrition Can Save America! FREE report by Mike Adams, the Health Ranger, reveals why nutritional deficiencies are destroying America's health and economy... and how to restore America's future with real food.

(NaturalNews) For the third time, Merck is seeking FDA approval for over-the-counter sale of its cholesterol-lowering statin medication lovastatin, marketed under the brand name Mevacor.

An FDA advisory panel voted against approving the drug for over-the-counter use on December 14, 2007. The recommendations of FDA advisory panels are not binding, but the agency usually follows them. After similar recommendations in 2000 and 2005, the FDA rejected Merck's applications to sell Mevacor over the counter.

In its December 14 decision, the FDA panel cited concerns that patients are not able to determine for themselves whether the cholesterol-lowering medication is right for them, the same concern cited in 2000 and 2005. The FDA has noted that high cholesterol is a chronic condition lacking overt symptoms, unlike other health problems that are currently treated over the counter.

"People can't, on their own, evaluate whether they are at sufficient enough risk that they could benefit from this drug," said physician Sidney Wolfe, who testified against the drug's approval to the FDA panel. Wolfe is the director of the Public Citizen Health Research Group.

At the FDA's recommendation, Merck added new warnings to the proposed labels for over-the-counter Mevacor since 2005. The labels say that the drug should not be used by men under the age of 45, women under the age of 55, pregnant or nursing women, or women who might become pregnant while taking the drug. According to Merck, recent studies indicated that the new labels helped consumers make better decisions about whether to take the drug. The FDA advisory panel disagreed.

The FDA is expected to decide on January 26 (2008?) whether to approve Merck's application. According to pharmaceutical industry consultant Steve Francesco, a decision to approve over-the-counter Mevacor "would be a real turning point" for the industry, paving the way for the approval of other over-the-counter medicines including more statins and drugs for allergy, dermatology and heartburn.

Share

Get articles like this delivered to you FREE in our popular email newsletter

Related CounterThink Cartoons:

Related Articles: • Merck litigation strategy - destroy expert witnesses • Leaked documents show Merck knew of Vioxx dangers, yet hid them for years • Merck Caught in Massive Scientific Fraud as In-House Authors were Disguised as Independent Scientists (opinion)	Take Action: Support NaturalNews.com Email this article to a friend Share this article on: NewsVine | digg | del.icio.us Permalink to this article: http://www.NaturalNews.com/023695_Merck_the_FDA_Mevacor.html Reprinting this article: Non-commercial use OK, cite NaturalNews.com with clickable link. Embed article link: (copy HTML code below): <a href = "http://www.NaturalNews.com/023695_Merck_the_FDA_Mevacor.html">Merck Pushing for Over-The-Counter Approval for Statin Drug Mevacor</a>