Controversy for Avandia: Calls to Have FDA Remove Avandia from Market
The popular drug Avandia (which is used to treat type 2 diabetes) has come under increased fire lately, with some calling on the FDA to order that the drug be taken off the market.
Avandia first was approved for treatment of type 2 diabetes in 1999. Even back then, concerns about Avandia's potential risks and side effects led to suggestions that Avandia be removed from the shelves. However, the FDA didn't even warn the public of its potentially fatal effects.
Then in 2007, a study conducted by the Cleveland Clinic and published in the New England Journal of Medicine reported that Avandia increases the risk of a heart attack by a staggering 43 percent. The same study concluded that Avandia increased the risks of cardiovascular death by an astonishing 64 percent.
The FDA's Role
The FDA originally based its decision not to remove Avandia from the shelves on recommendations that were made by an expert panel. The FDA instead issued a black box warning. Since the new concerns arrived, there are accusations that the drug's manufacturers, GlaxoSmithKline, withheld data that showed problems with Avandia. The accusations also claim that GlaxoSmithKline didn't properly warn the public and users of the drug of its potentially fatal side effects.
Currently there is evidence that proves that the FDA's internal staff also was warned but ignored the warnings. However, GlaxoSmithKline still maintains that the drug is safe for use and should not be removed from the shelves.
Critics of the FDA already have shown that their current procedure is a big factor that is preventing the agency from acting efficiently when a problem with a new drug has been found. The reason for the critics’ complaints is because the same department that is responsible for the initial investigation into a new drug's risks is also the department that decides if the drug will be approved. Most feel that this fact poses a sincere conflict of interest in the judging. Any information about risks that is discovered should be forwarded directly to the FDA commissioner so that proper action can be taken quickly, as opposed to transferring the information through the various levels of bureaucracy that the FDA currently uses, members of this camp argue.
With heart attacks being the leading cause of deaths in diabetics, this information should have been released to the public sooner. Had the FDA acted sooner and not ignored the initial warnings, chances are that many deaths could have been prevented. If you or someone you love thinks that they may have been hurt from using Avandia, contact an experienced attorney to learn more about your options.
