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Diabetes drug should be pulled over heart risks, FDA scientist says
By Andrew Bridges, Associated Press Writer
Monday, July 30, 2007 | No comments posted.
WASHINGTON - The widely used diabetes drug Avandia should be pulled from the market because of heart risks, a federal scientist said Monday.
Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.
The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.
Glaxo officials, meanwhile, disputed that conclusion, according to copies of company presentations to be given later today.
The FDA isn't required to follow the advice of its advisory committees but usually does.
The FDA moved up the date of today's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.
Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos.
About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia, also called rosiglitazone, might actually increase those risks would represent a “serious limitation” of the drug's benefit, according to the FDA.
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On the Net:
Avandia: http://www.avandia.com/
Food and Drug Administration: http://www.fda.gov/
Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.
The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.
Glaxo officials, meanwhile, disputed that conclusion, according to copies of company presentations to be given later today.
The FDA isn't required to follow the advice of its advisory committees but usually does.
The FDA moved up the date of today's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.
Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos.
About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia, also called rosiglitazone, might actually increase those risks would represent a “serious limitation” of the drug's benefit, according to the FDA.
---
On the Net:
Avandia: http://www.avandia.com/
Food and Drug Administration: http://www.fda.gov/
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