FDA took this action after its review of recent
safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and
pioglitazone (Actos), showed that Rezulin is more toxic to the liver
than the other two drugs. Data to date show that Avandia and Actos, both
approved in the past year, offer the same benefits as Rezulin
without the same risk.
"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 FDA's Center for Drug Evaluation and Research.
"We are now confident that patients have safer alternatives in this
important class of diabetes drugs," she added.
Severe liver toxicity has been known to occur with
Rezulin since 1997. In consultation with FDA, Parke-Davis has strengthened
the drug ís labeling several times and has recommended close monitoring
of liver function in patients taking Rezulin.
In March 1999, FDA's Endocrine and Metabolic Drugs
Advisory Committee reviewed the status of Rezulin and its risk of liver
toxicity and recommended continued availability of this drug in a select
group of patients -- patients not well-controlled on other diabetes drugs.
Since then, FDA has continued to actively monitor
adverse events associated with Rezulin, as well as Avandia and Actos.
After up to nine months of marketing experience with these two newer
drugs, it has now become clear that these newer drugs have less risk of
severe liver toxicity than Rezulin.
Patients using Rezulin are urged to contact their
physicians for information about alternative treatments. Patients should
not discontinue taking Rezulin or other treatments for diabetes
without discussing alternative therapies with their physicians.
For more information about Rezulin , go to FDA's