Statin Drug Manufacturer Recommends Putting Prescribing In The Hands Of Consumers

Merck & Co., in association with Johnson & Johnson, recommended that the FDA approve the statin drug Mevacor for over-the-counter sale.  Statin drugs block cholesterol production in the body.  Sales of Mevacor (generic term: lovastatin) over the counter would mean that consumers would be charged with the responsibility of determining when and if they needed this medication. Consumers would also be charged with determining whether or not they have any conditions that would make the use of Mevacor inadvisable.

Lovastatin is only recommended for people with cholesterol levels that are too high. High cholesterol levels can only be determined through blood tests. Use of lovastatin is inadvisable for people with liver disease or dysfunction, for  regnant or nursing women as "Mevaor may cause fetal harm when administered to a pregnant woman." In fact, the supporting documents on Mevacor advise that "liver function tests be performed before the initiation of treatment, at 6 and 12 weeks after initiation of therapy...and periodically thereafter." One of the other side effects of lovastatin is the disintegration or dissolving of muscles.

To make matters worse, in one Merck & Co. study only one percent of people who read the instructions and said they could start Mevacor therapy were correct!

Wisely, the U.S. advisory panel voted 20-3 against allowing Mevacor to be sold over the counter at this time. Despite this rejection, Bristol-Myers Squibb Co. planned to make its own application to the FDA to sell its statin drug Pravachol over the counter. Merck and Johnson & Johnson said that they would continue to work with the FDA on moving Mevacor over the counter.

An approval for over-the-counter sales would allow drug companies to launch advertising to sell this drug directly to consumers.

SOURCE: Reuters; health.yahoo.com;  druginfonet.com