Many Type 2 Diabetics Looking for a New Drug
WebMD News Archive
March 22, 2000 (New York) -- Phones are ringing off the hook in doctor's offices across the country as the approximately 500,000 type 2 diabetics who currently take the drug Rezulin wonder what to do now that the drug has been pulled from the market.
After being asked by the FDA, Warner-Lambert/Parke-Davis voluntarily agreed Tuesday to withdraw Rezulin, its highly controversial type 2 diabetes drug, due to reports of severe liver damage. The FDA made its request because patients now have safer alternatives in the same class of drugs. Nine months of data show that these alternatives, Avandia (rosiglitazone) and Actos (pioglitazone), have the same benefits as Rezulin -- without the risks.
Part of a class of diabetes drugs known as 'glitazones,' Rezulin helps the body use its own insulin supply. It is often prescribed in conjunction with insulin. Mired in controversy from the beginning, the drug was pulled from the market in Britain in 1997 due to reports of severe liver damage. These reports prompted the FDA to require labeling changes in the U.S. urging doctors who prescribe Rezulin to monitor patient's liver changes.
"Basically, we are telling all of our patients to stop taking Rezulin and asking them to come in to take a blood test measuring their liver function to identify whether they have liver abnormalities," James Rosenzweig, MD, the associate director of adult diabetes at the Joslin Diabetes Center in Boston, tells WebMD. He is quick to point out that most patients taking Rezulin have been getting regular blood tests all along.
"If their tests come back normal, we will switch them to another medication in the same class or in a different class," he tells WebMD. It's unfortunate, he says, that Rezulin does work well in a large number of patients.
Carol Whitty, 54, is one of those patients. Whitty was first diagnosed with type 2 diabetes about seven years ago and has been taking Rezulin for three years. Fortunately, she had an appointment scheduled with Rosenzweig this morning.
"To me," she tells WebMD. "Rezulin was a miracle drug, because it allowed me to stop taking insulin, and I had no side effects." Rosenzweig switched Whitty to Actos, and she is optimistic that the new drug will work as well as Rezulin.
Like Whitty, "patients taking Rezulin should see their doctor, and if it looks like Rezulin has been working, it may make sense to switch to another drug in the same class," says Barry J. Goldstein, MD, PhD, director of the division of endocrinology, diabetes, and metabolic diseases at Jefferson Medical College in Philadelphia.
For example, Avandia has clear guidelines for switching on its label, he tells WebMD. "It suggests waiting seven days before starting a new drug in the class because the Rezulin remains in the system for that length of time," he says.