DOCTOR'S VIEW ARCHIVE
Rezulin Withdrawn From Market Warning
Rezulin is the brand name for a drug called troglitazone and has been used in patients with type II diabetes to help lower and control blood sugars that are not controlled by insulin or by other oral anti-diabetic medications.
Because of increasing numbers of reports of patients who were taking Rezulin that developed serious liver toxicity, the Federal Drug Administration (FDA) has requested that the manufacturer, Parke-Davis/Warner-Lambert, withdraw the drug from the market. Parke-Davis/Warner-Lambert has agreed to implement an immediate withdrawal program.
The actual announcement by the FDA follows. Please note especially the last paragraph which reads "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."
-- Medical Editor, MedicineNet.com
March 21, 2000 WASHINGTON, D.C. --FDA today asked the manufacturer of Rezulin (troglitazone) - a drug used to treat type 2 diabetes mellitus - to remove the product from the market. The drug's manufacturer, Parke-Davis/Warner- Lambert, has agreed to FDA's request.
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.