FDA’s Statement on Report of Adverse Effects from Rezulin

1. The FDA is actively monitoring these adverse reaction reports. A key element in this process is careful analysis of each report to determine whether the drug is actually a significant cause of the injury or death or whether these problems can be attributed to other factors (e.g. underlying health problems, other drug interactions, etc.). Until this analysis is done, it is impossible to conclude that the drug caused the injury or death.

2. Drugs are removed when they pose an unacceptable risk to patients — when it is established that their potential risk outweighs their potential benefit. The number of raw adverse reaction reports filed cannot determine this. Again, careful medical analyses are essential in determining whether a drug is causing injuries. Such analyses may demonstrate that a large number of reports actually reveal no link between injuries and a drug; on the other hand, analysis of a small number of reports can reveal a clear disturbing pattern that would lead to a drug’s removal.

3. Since the safety of troglitazone was reviewed by the Metabolic and Endocrine Drugs Advisory Committee in March 1999, a total of nine cases of death due to liver failure that are possibly or probably related to troglitazone have occurred and have been reported to the FDA through MEDWATCH. The Agency is continuing to actively evaluate the risks and benefits of troglitazone as well as the risks and benefits of other members of this drug class that are marketed in the United States to determine whether any further regulatory actions are warranted.

Source: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Washington, DC.