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After Rezulin
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If you were one of the 500,000 people with diabetes who were taking Rezulin when
it was with drawn from the market, you might be wondering, what's next?
By Terri D'Arrigo
 In
the latest turn of events in the ongoing saga of Rezulin (troglitazone), on March
21 the Food and Drug Administration (FDA) requested the drug be removed from the
U.S. market. Parke-Davis, the division of Warner Lambert that makes Rezulin, agreed
to the FDA's request.
Rezulin's withdrawal from the market is the latest twist in the firestorm of controversy
that has swirled around the type 2 drug. The FDA had previously determined that
Rezulin was linked to 89 confirmed reports of liver failure, including 61 deaths,
prompting calls from consumer groups for the drug's withdrawal. Rezulin was pulled
off the market in Britain in December 1997.
The FDA granted "fast-track" approval to Rezulin in March 1997. Since then, Parke-Davis
had changed the drug's labeling four times, in line with recommendations from the
FDA. The revisions in the labeling increasingly emphasized the importance of regular
liver function tests to help ensure safer use of the drug. About 750,000 people
have used Rezulin, and about 500,000 were taking the drug at the time of its withdrawal.
Rezulin was the first in a class of drugs called thiazolidinediones (TZDs or "glitazones"),
which help the body become more sensitive to insulin. The other two drugs in this
class are rosiglitazone (Avandia, SmithKline Beecham) and pioglitazone (Actos, Takeda
Pharmaceuticals America and Eli Lilly and Company), both of which were approved
last year. According to the FDA, the request to remove Rezulin from the market came
after a review of test data revealed that Rezulin was more toxic than the other
two glitazones on the market.
"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," says
Janet Woodcock, MD, 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."
In a statement released March 15, the American Diabetes Association noted that it
"does not believe the safety concerns regarding [Rezulin] extend to the other two
medications, which are in the same class of diabetes drugs." Nonetheless, the Association
says, "as with all diabetes medications and devices, this class of drugs will need
further monitoring and research to ensure its long-term safety and efficacy."
Now What?
If Rezulin was part of your diabetes care plan, the FDA recommends that
you talk to your doctor about other treatment options, not only within the TZD class,
but among other classes of drugs as well. The American Diabetes Association recommends
that you work closely with your doctor or health care team to help decide the best
treatment for you. It is crucial that you do not make any changes in your diabetes
care regimen without consulting your health care team first.
Other treatment options include insulin as well as other kinds of drugs that work
differently from the TZD class. Metformin (Glucophage) keeps the liver from releasing
too much glucose, sulfonylureas and repaglinide (Prandin) stimulate the pancreas
to release more insulin, and acarbose (Precose) and miglitol (Glyset) slow the digestion
of some carbohydrates so after-meal blood glucose peaks aren't as high.
Should you continue to have your liver function tested even after you've stopped
taking Rezulin? That depends, says John Jenkins, MD, director of the Office of Drug
Evaluation II and acting director of the division of metabolic and endocrine drug
products at the FDA. If you and your doctor decide to go with another TZD, you should
have regular liver function tests as indicated on the labeling for both rosiglitazone
and pioglitazone. However, it gets sketchy if you and your doctor decide to try
a drug in another class.
Says Jenkins; "The FDA has no specific recommendations con-cerning [continued liver
function tests]. We don't have the data to support such recommendations." However,
he adds that there have been cases of liver damage reported even after patients
have been taken off the drug, which indicates that the risk does not instantly disappear
when patients stop using Rezulin. "Each case is unique," he says. "It depends on
the case history and history of drug interactions. That's why we recommend that
people discuss their options with their doctor."
Used with permission from
Diabetes Forecast, May 2000. Copyright 2000 American Diabetes Association, Inc.
For information on joining the American Diabetes Association and receiving Diabetes
Forecast, call 1-800-806-7801, and for more information, see
www.diabetes.org
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