Doctors See Easy Switch From Rezulin
Diabetes patients who were taking the pill Rezulin--which is being pulled from the market--should have no problem switching to an alternative drug, experts said Friday.
“It would be a relatively seamless transition because there are other choices,” said Dr. Norman Lavin, director of the Diabetes Center at Tarzana Medical Center in Los Angeles.
Rezulin was one of about a dozen drugs available for treatment of adult-onset Type 2 diabetes. The drug lowers blood-sugar levels in patients.
The Food and Drug Administration said that two drugs in the same chemical class as Rezulin, Avandia and Actos, “offer the same benefits as Rezulin without the same risk.” The FDA has linked Rezulin use to 90 liver failures, including 63 deaths and seven nonfatal organ transplants.
Doctors are advising Rezulin patients not to worry and are upbeat that alternative drugs are safer and carry fewer side effects.
“Go to your doctor, get a prescription for a new drug and they [patients] will do just as well, if not better,” said Dr. David S. H. Bell, a professor and diabetes specialist at the University of Alabama at Birmingham School of Medicine. “There is no reason to be nervous and have any fear.”
Bell, who has done extensive research on helping patients make the transition from Rezulin to alternative drugs, transferred all 150 of his Rezulin patients to Avandia or Actos last summer when the two drugs were approved for use. Bell conducts chemical trials for manufacturers of both drugs.
A Week’s Delay Before New Regimen Suggested
“There was no deterioration in control of diabetes--they had no side effects whatsoever,” said Bell, who suggests that patients wait one week before starting a different drug.
Dr. Riccardo Perfetti, director of the diabetes program at Cedars-Sinai Medical Center in Los Angeles, warned that Avandia and Actos appear to be less toxic than Rezulin but said that all medications can carry risks.
“Patients want to make sure there are no side effects. Unfortunately such a thing doesn’t exist,” Perfetti said. He said that patients making the switch should continue to undergo regular liver monitoring.
“Unfortunately, I have seen many patients who came to me on Rezulin that were not monitored at all,” Perfetti said. “There was big confusion and mismanagement of how the drug was administered to patients. It was so poorly done at all levels.”
Rezulin, which won “fast-track” government approval in January 1997, was first reported to be tied to liver failure and death in October of that year. Two months later, the drug was pulled from pharmacy shelves in Britain.
Lavin said that, because of the known risk of the drug, doctors at the Diabetes Center in Tarzana have moved about 20% of their thousands of patients who were taking Rezulin to Avandia or Actos. He said that those people “are doing fine.”
Drug ‘Under the Gun’ for Years, Doctor Says
“This did not come from left field,” he said. “It is well-known by endocrinologists and the public at large that Rezulin has been under the gun for a few years.”
Lavin said that his office has contacted patients still taking Rezulin about the recent FDA decision.
Before Tuesday’s announcement that the drug was being withdrawn, the FDA reported that about 500,000 people were using Rezulin. According to sales data provided by IMS Health, 300,000 prescriptions were written for Rezulin last month.
To date, the only advice given to patients by the FDA and Rezulin’s manufacturer, Warner-Lambert Co., is to contact their doctors before discontinuing the medicine. The American Diabetes Assn. is preparing a list of questions and answers for patients and doctors making the transition to new treatments. It is expected to be posted on the ADA Web site--www.diabetes.org--by the middle of next week.
Actos is distributed by Takeda Pharmaceuticals America Inc. and co-marketed with Eli Lilly and Co. The drug is taken once daily. There have been no linked cases of liver abnormalities associated with the drug. Since it was launched in August 1999, about 350,000 patients have taken the drug, according to the manufacturer.
Avandia, which has been linked to one liver failure death, is manufactured by SmithKline Beecham PLC of Britain and is co-marketed in the United States by New Jersey-based Bristol-Myers Co. It is taken either once or twice per day. More than 700,000 patients have used Avandia since it became available last June.
