Safety of Avandia to Be Reevaluated by FDA

One of the primary functions of the U.S. Food and Drug Administration (FDA) is to evaluate the safety of medications. Currently, the FDA will begin a reevaluation of Avandia (a drug used to treat Type 2 Diabetes).

In 2010, restrictions were placed on Avandia’s use after a study showed the potential to cause: 

  • congestive heart failure;
  • cardiac arrest; and
  • stroke.

The manufacturer, GlaxoSmithKline, was accused of knowing about these risks and failing to report them. At this time, it can only be prescribed after patients have signed a waiver which indicates that other medications have been tried and that a physician has explained the risks of using the drug.

An advisory panel comprised of outside experts will consider testimony on the drug. GlaxoSmithKline stands by its claims that it’s as safe any other drug prescribed for the treatment of diabetes, while some scientists for the FDA claim that adverse reactions to the drug were underreported.

Manufacturer Liability for Dangerous Drugs

When manufacturers know of potential serious risks with a drug, they must be reported to the FDA. Failing to do so could result in civil and/or criminal penalties. This was the case with GlaxoSmithKline who paid a $3 billion settlement that involved ten of its drugs.

But there are legal repercussions that could be faced when a patient is seriously or fatally injured by a dangerous drug. As a citizen, you are not expected to know extensive histories of drugs, their interactions, or their side effects unless a doctor tells you. It could lead to damages that address medical costs, lost wages, pain and suffering, wrongful death and more. Victims or their families should contact an attorney at Gacovino, Lake & Associates to learn if they have a case against a drug manufacturer for a dangerous drug that caused injuries.

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