The FDA held a hearing in 1999 in response to growing concern over the drug's potential to cause liver dysfunction and, as a result, death. At that time, there were reports of forty-three cases of liver failure, twenty-eight of which had resulted in death. The FDA hearing was well attended by diabetes patients, doctors, drug-company representatives, and consumer advocates. The hearing process concluded with a decision to allow Rezulin to remain on the market, provided that the drug's label contain warnings about possible liver dysfunction associated with Rezulin use, and a statement that patients must undergo regular blood tests to determine liver function.

On March 21, 2000, the FDA advised Rezulin's manufacturer to withdraw the drug from the market, citing ninety cases of reported liver failure, sixty-three of which had resulted in death. The FDA also noted that two newer drugs, Avandia and Actos, that act in a similar manner to Rezulin have appeared on the market and that these drugs seem to be safer alternatives to Rezulin. Rezulin was withdrawn from the market immediately after the FDA advised Warner-Lambert to remove it.

Possible Concealment of Data by Drug's Manufacturer

Recently, medical experts have criticized the drug's manufacturer and the FDA for allowing the drug to be marketed despite the knowledge that the drug is linked to liver failure. In fact, the principal researcher in a study of Rezulin sponsored by the drug's manufacturer, Warner-Lambert, has stated that she reported to the manufacturer that two of her twenty patients taking Rezulin suffered liver dysfunction, but Warner-Lambert pressured her to downplay the problems with the drug. Moreover, the researcher has stated that Warner-Lambert failed to adequately report those instances of liver dysfunction in reports it submitted to the FDA when Warner-Lambert was seeking FDA-approval of Rezulin.

Rezulin's Mechanism of Action

Rezulin is what is known as a "thiazolidinedione antidiabetic agent" which lowers blood glucose levels by improving the cells' response to insulin. In effect, Rezulin is thought to help diabetics use insulin more effectively. Its mode of action, therefore, necessitates the presence of insulin in the body for the drug to work properly.

Rezulin's Manufacturer

Rezulin is manufactured by Parke-Davis, a division of the Warner-Lambert Company, located in Morris Plains, New Jersey. Warner-Lambert manufactures prescription drugs, but also over-the-counter drugs, breath mints, and chewing gum. In 1998, Warner-Lambert reported net sales totaling over ten billion dollars.

Individuals who have questions regarding Rezulin should contact Warner-Lambert at 1-877-798-7398. The phone number for the company's Medical Affairs Department is 1 -800-223-0432. For more information about Warner-Lambert, you can visit its Web site at www.warner-lambert.com

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