(Circulation. 2000;101:e9027.)
© 2000 American Heart Association, Inc.
Drugs and Disease
An extract of the first 250 words of the full text is provided, because this article has no abstract. |
Two Drugs With Troubled Pasts Will No Longer Be Marketed in the United States
Two drugs that have required frequent changes in warning labels will not longer be sold, at least in the United States, according to their manufacturers. The manufacturers made their announcements in the same week in March.
On March 21, 2000, the US Food and Drug Administration (FDA) asked Parke-Davis/Warner-Lambert, the manufacturer of the type 2 diabetes drug Rezulin (troglitazone), to remove the drug from the market and the company agreed. After months of lobbying by various healthcare advocates such as Sidney Wolfe, MD, of the Health Research Group of the Public Citizen organization, the FDA took the action after comparing the safety data on Rezulin to those of 2 similar drugs, Avandia (rosglitazone) and Actos (pioglitazone), and finding that Rezulin was the most liver toxic. "When considered as a whole, the pre-marketing clinical data and post-marketing safety data from Rezulin as compared to similar, alternative diabetes drugs indicate that continued use of Rezulin now poses an unacceptable risk to patients," said Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. Now that patients have an alternative to Rezulin, she said the action to withdraw it was reasonable.
Parke-Davis had strengthened the warnings on the drug’s labeling
several times since the drug was approved, and the company had
recommended closely monitoring liver function in patients who take the
drug. In March 1999, an FDA advisory committee reviewed the safety data
and recommended that