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Withdrawing Risky Drugs from the Market

With recent pushes to remove the once popular prescription drug Avandia from the market comes a greater awareness of the risks of prescription medication.

In July, a medical advisory panel for the U.S. Food and Drug Administration (FDA) reviewed claims about the serious, even fatal side effects caused by taking the diabetes medication Avandia, which used to be the world's leading drug for combating high blood-sugar levels. Among the risks of Avandia is an increased risk of heart attacks.

At the conclusion of the Avandia hearings, the majority of the 33-member advisory panel voted to withdraw the prescription drug from the market, narrowly outvoting 10 members of the panel who suggested restricting rather than banning Avandia sales. With such a split vote on the advisory panel, it is unclear how the FDA will respond to the panel's recommendations.

A similar diabetes medication, Rezulin, was withdrawn from the market in 2000 after the drug was linked to fatal liver damage.

Withdrawing a Drug From the Market

In considering whether a drug should be removed from the market, the FDA considers numerous factors, including:

  • The prevalence of a safer alternative
  • The severity of the possible harm
  • The seriousness of the illness treated by the drug compared to the harm
  • The magnitude of evidence against the use of the drug

In the cases of both Avandia and Rezulin, critics have argued that the initial trials lacked trustworthiness and were insufficient to demonstrate drug safety. The FDA is currently reviewing pre-market clinical trial standards to determine whether more rigorous standards exist that could improve trial quality.

Products Liability and Risky Prescription Drugs

Prescription-drug makers may be held responsible for serious side effects of harmful drugs. For more information on prescription drug reactions and product liability, contact an experienced personal injury attorney in your state if you or someone you know has been harmed by dangerous medication.

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