Dr. von Eschenbach, the Commissioner of the U.S. Food and Drug Administration, defends the FDA's handling of emerging safety data on potential heart risks associated with the diabetes drug Avandia.
Our policy, which we followed with Avandia, is to inform the public about potential risks at the earliest appropriate time, even if our investigation is not complete.
This week, we announced the possible cardiac risk because we wanted to inform patients and physicians, note that the data indicating the possible effects on the heart are complex and contradictory, and point out that we are seeking additional data to decide whether any regulatory action is needed.
What has FDA been doing? About a year ago, we warned about this possible risk in Avandia's labeling. Since receiving additional information from Avandia's maker last August, FDA has been analyzing data from 42 previous studies in detail, expanding on the work done by the drugmaker. We have been working to obtain and analyze data from other studies, some of which appear to contradict the findings of the earlier 42 studies.
Some have questioned why FDA did not speak out on this issue sooner. We are constantly acquiring information on drugs, and any FDA comment about the safety of a drug must do more than simply raise alarm. This is especially true in the case of a diabetes drug, such as Avandia (rosiglitazone). For diabetic patients, an abrupt and unjustified change in medication can have serious health consequences. We will continue to inform the public about FDA's review of the benefits and risks of taking Avandia.