Avandia Causes Problems it’s Supposed to Prevent, FDA Concludes
The FDA recently came to the conclusion that many drugs are actually causing the problems that they claim to prevent. One such drug is Avandia.
Used to treat type 2 diabetes, Avandia recently has been under fire for increasing user risks of having heart attacks and strokes. Since two-thirds of all diabetics die of heart complications, it seems almost ridiculous to prescribe a diabetic drug that causes the heart problems that it is meant to protect these diabetics from.
It was for these reasons and a few others that Europe took the drug off the market — and why the FDA eventually issued a severe restriction that prevents Avandia from being widely available in the United States. So many Americans currently are battling chronic diseases, and the fact that they’re taking a wide variety of drugs to combat them has FDA officials increasingly careful about drug safety. So far it isn't clear what the nation should do in regards to the overwhelming use of prescription drugs that are taken to combat all of these chronic diseases, but safety restrictions have to be taken into account.
The hard part is trying to figure out the best way to assess the safety of drugs that a patient will be using for decades. This is difficult because the clinical trials that are being used right now only chronicle the use of the drugs for a couple of years at most. Drugs are shipped out to the market before they have been tested properly through clinical trials to assess just how risky they are. By the time anyone figures how significant the risks are, the lawsuits are already pending.
Right now, all that is done to test drugs like Avandia is to ask doctors to report adverse reactions and rely on researchers to look at patient experiences through different databases, such as checking the records of large health plans.
“There has to be a better system,” says Dr. Clifford J Rosen, director of the Maine Center for Osteoporosis Research. “The basic underlying theme is that we don’t have good, long-term safety indices for common chronic diseases that we are treating with major drugs.”
Not only does Rosen study osteoporosis, he also served on an FDA advisory committee that checked the proof that Avandia had links to heart risks. The current system of assessing these drugs clearly doesn't work. While Congress recently gave the FDA the ability to require studies even after drug approval, the agency hasn't done so except in rare cases.
