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Diabetes drugs may cause heart failure - report
Diabetes drugs may cause heart failure - report -- Posted by Gumbo on 11-04-04 17:26
Diabetes drugs may cause heart failure - report
Sep 10 (Reuters) - Two popular drugs used to treat type- 2 diabetes can
cause fluid buildup and heart failure in some patients, US doctors said on
Tuesday.
The drugs, sold under the brand names Avandia and Actos, caused heart
failure and a buildup of fluid in the lungs in six men with poor kidney or
poor heart function, the researchers said.
"It seems to me these drugs may not be safe in such patients. They may not
be able to tolerate fluid overload induced by such drugs," said Dr.
Abhimanyu Garg, a professor of internal medicine at the University of Texas
Southwestern Medical Center at Dallas, who led the study.
Makers of the drugs disputed whether the study in fact showed a direct link
between the medications and the heart failure in the patients.
Nonetheless, the findings, published in the Mayo Clinic Proceedings, were
another potential blow to the newest class of diabetes drugs, the
thiazolidinediones or glitazones.
The first drug in the class, Rezulin, was pulled from the market in March
2000 after about 100 people who took it died from acute liver failure or had
to have liver transplants.
Pfizer Inc., which owns Rezulin as part of its purchase of Warner-Lambert
Co., is fighting off thousands of lawsuits alleging that Warner-Lambert
failed to inform the public of the drug's health risks.
In June, 32 patients filed lawsuits against GlaxoSmithKline Plc, which makes
Avandia, known generically as rosiglitazone, claiming damaging fluid
buildup.
The six men whose cases are detailed in the report took either Avandia or
Actos, known generically as pioglitazone and jointly marketed by Japan's
Takeda and Eli Lilly & Co. Inc.
An estimated 6 million Americans take one or the other of the drugs.
HIGH-RISK PATIENTS
"Many physicians are prescribing these drugs in patients with chronic renal
(kidney) insufficiency because a first-line diabetes drug, metformin, is not
recommended for them," Garg said.
"These new data suggest that such patients may be at particularly high risk
of developing heart failure."
The six patients showed up at the Veterans Affairs Medical Center in Dallas
with either heart failure and pulmonary edema, a potentially fatal condition
in which fluid builds up in the lungs because the heart is not working
efficiently.
The drugs increase blood volume, and the drugs are not approved for use in
patients with the most advanced heart dysfunction. Garg said those six men
all had mild to moderate heart and kidney problems.
Luckily, he said, the patients were treated, taken off the glitazone drugs
and all recovered.
Makers of the drugs said the findings involved only a small group of
patients and that the findings were not necessarily surprising.
"These patients should be observed for signs and symptoms of heart failure,"
Dr. Mehmood Khan, vice president for medical and scientific affairs at
Takeda, said in a telephone interview.
"This is already on the product label. We already know that this class of
drugs can cause fluid retention," added Khan, who is an endocrinologist.
Glaxo spokeswoman Bernadette King said Avandia was labeled clearly and the
company was confident about winning the lawsuit. "What we are trying to do
is make sure physicians are understanding the label very clearly," King said
in a telephone interview.
King also said the patients in the study were high risk and were taking
higher-than-indicated doses of Avandia.
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