Ottmers finally stopped taking the drug after discovering on the Internet that the medicine could cause rare but life-threatening liver damage. But her health continued to decline, and 16 months after she began taking the drug she was forced to undergo a liver transplant. She has since sued Warner-Lambert, the company that makes the drug, Rezulin.

Critics point out that the FDA's lead reviewer of Rezulin, John Gueriguian, opposed its approval and was removed from considering the application. Gueriguian said he found the company's safety testing inadequate and its claims of efficacy unconvincing. Even more, he said, his review of animal studies and clinical trials that revealed rare signs of jaundice signaled that the drug had hidden dangers. Nevertheless, the FDA approved the drug in March 1997 with exceptional speed because it offered a new way to control diabetes.

As large numbers of patients began taking Rezulin, the liver damage reports started to come into the agency's system for monitoring drug side effects. As evidence mounted that some patients could be harmed or even killed by the drug, the agency changed the labeling on the drug -- not once but three times -- to require more extensive testing of patient liver function. Since that time, confirmed reports of damage linked to Rezulin have dropped, but unconfirmed reports of liver damage continue to come into the agency. A Washington-based consumer advocacy organization, Public Citizen's Health Research Group, has filed a petition demanding that the agency remove Rezulin from the market.