Looks like another player in Big Pharma is taking heat for being slow to withdaw a medication that wasn’t safe. (AP):
This time it’s Baycol, a cholesterol-lowering medicine that Bayer AG withdrew in 2001 after some people who took it developed a severe and sometimes fatal muscle disorder. A new study found that the risks were far greater than had been believed.
The study concludes that today’s top-selling cholesterol-lowering drugs, called statins, are very safe, but could be risky when taken with other drugs called fibrates by older people with diabetes. It also reveals that fibrates alone can be dangerous. These drugs lower triglycerides and often are taken by diabetics.
Six papers on the issue were released Monday and will be published Dec. 1 in the Journal of the American Medical Association. Its editors call for a new, independent office separate from the FDA to monitor drugs after they’re on the market.
“It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong,” they write.
FDA officials did not return phone calls seeking comment Monday.