Rezulin Withdrawn from Market
The United States Food and Drug Administration (FDA) has requested that the diabetes drug troglitazone, sold under the brand name Rezulin, be withdrawn from the market. The drug has been linked to 63 deaths and 90 confirmed cases of liver failure since entering the market in mid-1997.
Public Citizen, a Washington, DC consumer advocacy group has urged the FDA to conduct a criminal investigation of the maker of Rezulin, Warner-Lambert. Public Citizen says that the company failed to notify the FDA within the 15 day limit required by law when studies showed the drug resulted in liver toxicity. The group says that Warner-Lambert did not inform the FDA of the studies until after the drug was approved for sale.
Rezulin generated Warner-Lambert revenues of $625 million in 1997 and $748 million in 1998.
On September 8, 2003 the Mayo clinic found that diabetes drugs may cause heart failure and cause fluid buildup in some patients. The first drug in the newest class of diabetes drugs was Rezulin. In March 2000 regulators found the drug to pose such a great risk of adverse effects that a Rezulin recall was issued.
As disturbing as this recall is, in the August 15, 2001 issue of the Journal of the American Medical Association published a letter from Dr. David Graham and his colleagues at the U.S. Food and Drug Administration (FDA). The authors concluded that many doctors ignored FDA letters warning them of dangerous reactions to the recently banned diabetes drug Rezulin and continued to prescribe it to patients. Four separate letters, from the drug company that produced Rezulin, were sent to U.S. doctors at the request of the FDA warning them of dangerous liver damage that was occurring in patients taking the drug. The letters recommended continuous monitoring of liver enzymes to determine if liver damage was occurring. According to Dr. Graham, the letters and extensive publicity "did not result in sustained or meaningful improvement in the performance of liver enzyme testing of patients taking the drug."
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