FDA Reviews When Bayer Revealed Drug Risks (Baycol)

[Khephra]

WASHINGTON -- In a move that could lead to a criminal investigation, the government is checking its records to determine if drug maker Bayer AG was forthcoming about safety concerns with its cholesterol-lowering Baycol drug that surfaced within months of it hitting the market.

If this week's allegations prove true that the company knew but was slow to inform the government that its drug was riskier than comparable drugs, the Food and Drug Administration could begin a criminal investigation, one official said this week.

Bayer internal company records now in the public domain indicated that by May 28, 1998, three months after the drug went on the market, people who took the drug with gemfibrozil, another cholesterol-lowering drug, had elevated levels of an enzyme that accompanies muscle injury or had developed a rare muscle-wasting disorder. Bayer did not warn doctors and patients not to take the two drugs together until December 1999, four scientists wrote in a Journal of the American Medical Association paper released this week.

In addition Bayer scientists knew in late 1999 and early 2000 that using Baycol alone "substantially increased the risk" of people getting a rare muscle-wasting condition, compared with a rival drug, but they did not immediately alert physicians or patients. FDA rules require speedy notification of serious side effects linked to drugs.

http://www.newsday.com/news/health/wire/sns-ap-fda-cholesterol-drug,0,7719979.story?coll=sns-ap-health-headlines

[Ima]

1. It's really upsetting

what Bayer, and other large Pharma, get away with. They are killing people.

[Lizzie Borden]

2. Bayer ...the company that brought you

Hitler's "jew" gas. You shouuld be already boycotting this copany as well as Volkswagon.