E-Drug: Call to ban diabetes drug in U.S.
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Public Citizen seeks troglitazone recall
WASHINGTON, DC, Jul 28 (Reuters) - Public Citizen's Health Research
Group on Monday asked the Food and Drug Administration (FDA) to recall
the diabetes drug troglitazone, saying that since its approval in
March 1997, the drug has been associated with at least 26 deaths from
liver failure and three liver transplants.
The drug, sold as Rezulin by Warner-Lambert, was banned in December
1997 from Britain by that nation's Committee on Safety of Medicines.
Within days, co-marketer Glaxo Wellcome withdrew its application for
European approval.
At the time, the FDA reiterated that the benefits of troglitazone
therapy outweighed the risks. But the agency required a boxed warning
to be added stating that monitoring of liver function should be
stepped up to 11 times a year. In late 1997, the FDA had suggested
--after starting to receive reports of liver failure--that
physicians monitor patients five times a year.
In its petition, Public Citizen said the labeling precautions weren't
enough. As of June 5, the FDA had received 560 reports of liver
toxicity associated with troglitazone use, said the group. And, says
Public Citizen, since adverse events are generally underreported to
the FDA, "it is likely that there may be as many as 200 deaths from
liver damage which have actually occurred."
The group says a patient death in a National Institutes of Diabetes
and Digestive and Kidney Disease study of troglitazone was enough to
stop the trial in June. The drug was being studied in the prevention
of diabetes in at-risk patients.
Warner-Lambert's Parke-Davis division is due to send out a new Dear
Doctor letter this week. But Public Citizen said any warnings or
labeling changes "are doomed to the same failure as the previous,
similar warning efforts with the drug."
[Full petition can be accessed by visiting Public Citizen's website:
http://www.citizen.org]
Rizwan
srahmad@essential.org
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