March 22, 2000Severe Liver Toxicity Prompts
Withdrawal of Rezulin from the Market
Houston, TX (SafetyAlerts) - Parke-Davis owner of
Warner-Lambert has agreed to a request by the FDA to remove Rezulin (troglitazone)
a drug used to treat type 2 diabetes mellitus from the market.
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.
Severe liver toxicity has been known to occur with
Rezulin since 1997.
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.
In March 1999, FDAs 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.
Notice of this product warning was sent via email
to SafeMail subscribers March 22,
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.