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Liver Toxicity Conference

The FDA recently held an international conference to discuss the problem of liver toxicity. The conference was held February 12-13, 2001 in Virginia. Details from the conference can be found at the FDA web site.

Warnings Ignored

New research indicates that warning labels and letters sent from the FDA did not deter doctors from improperly prescribing the diabetes drug Rezulin. Doctors failed to perform liver enzyme tests to measure liver toxicity even after the FDA sent four separate letters. Rezulin was recalled in March 2000 after being linked to approximately 94 reports of liver failure.

Rezulin Recalled

Rezulin was voluntarily pulled from the market in March 2000 at the request of the FDA. Rezulin had been linked to approximately 63 liver poisoning deaths. The manufacturer of the drug withdrew it from the market, but issued a statement outlining its continued confidence in the drug. The FDA has said that two other drugs on the market, Avandia and Actos, offer the same benefits as Rezulin but without the risks.

FDA Slow to Respond to Rezulin Dangers

Only eight months after the approval of Rezulin, reports of liver failure began to stream in to the FDA. Instead of immediately recalling the drug, the FDA decided to strengthen label warnings and send letters out to physicians informing them of the label changes. This was done four times. Shortly before Rezulin was withdrawn from the market, a scientist involved in the initial clinical trials wrote a letter to the FDA and members of Congress informing them that Warner Lambert had withheld information about two liver failures that occurred during the clinical studies. Finally, over two years after the first reports of liver failure reached the FDA, Rezulin was recalled.

If you or someone you know has suffered injuries as a result of Rezulin, contact an attorney to discuss your legal rights.

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