After the FDA approval of Rezulin on January 29, 1997 for a fast track to market, a complete clinical trial to determine possible heart damage had not yet been completed. However, officials had negotiated a nonbonding pledge from Warner-Lambert, the drugs' maker, to start a new study to assess Rezulin's effect on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed.

Rezulin patients did die of heart failure, but doctors claimed many of these patients had preexisting heart problems. Guston Turner, a pharmacist from the FDA's scientific investigations division, felt that the FDA "should have delayed approval of Rezulin until all the questions were addressed."

If you or a loved one has suffered a serious injury while taking Rezulin, please submit the accompanying form. You may be entitled to monetary awards for your injury!