ROCKVILLE, Md.-Rezulin, a relatively new drug used to treat diabetes mellitus type 2, has been withdrawn from the market amid reports that the drug is toxic to the liver.
On March 21, the Food and Drug Administration (FDA) asked Warner-Lambert/Parke-Davis to take its drug off the market, and the manufacturer agreed.
Reports of liver toxicity, leading to the need for liver transplantation in some patients, have surrounded Rezulin (troglitazone) since it came on the market in 1997. Labeling of the drug has been strengthened several times since then, but Rezulin reportedly has been associated with at least 60 deaths and about 90 cases of liver failure.
The Department of Health and Human Services (HHS) said in a press release on March 21 that the drugs Avandia (rosiglitazone) and Actos (pioglitazone), both of which were approved within the past year, "offer the same benefits as Rezulin without the same risk." Data indicate "that continued use of Rezulin now poses an unacceptable risk to patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in the statement.
"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," HHS said.
In a statement about the discontinuation of Rezulin, "Warner-Lambert, of Morris Plains, N.J., said that "the company continues to believe that the benefits of the drug outweigh its associated risks."
For Your Information:
See www.warnerlambert.com and www.fda.gov/bbs/topics/NEWS/NEW00721.html. The group Public Citizen posts a letter to HHS regarding Rezulin at www.publiccitizen.org/hrg/PUBLICATIONS/1516.htm.
Please be aware that medical advice, diagnoses and physician references cannot be obtained from this site.