A study published in The New England Journal of
Medicine showed that Avandia significantly increased the risk of heart
attacks, as compared to other diabetes drugs or a placebo.
More than 6 million people worldwide have taken the drug
since it came on the market eight years ago. Pooled results of dozens of studies
revealed a 43 percent higher risk of heart attack, according to the review
published by The New England Journal of Medicine. Dr. Steven Nissen
reviewed more than 40 clinical studies involving 28,000 patients. He estimates
that tens of thousands of people had heart attacks as a result of Avedia.
The Food and Drug Administration urged diabetics taking
the pill to talk to their doctors, but stopped short of forcing a sharper
warning label on the drug sold by GlaxoSmithKline PLC of London.
GlaxoSmithKline has been aware of these concerns
since at least August 2006 when it conducted a similar analysis. Notwithstanding
its own analysis, GlaxoSmithKline defended the safety of Avandia and claimed the
drug has a comparable cardiovascular profile to other oral antidiabetic
medicines
In August 2006, a similar analysis by GlaxoSmithKline
identified a 31 percent increase in cardiovascular risk. Although the company
alerted the FDA to the safety concerns, it did not notify doctors or patients of
the heart problems associated with the drug.
FDA officials acknowledged that Glaxo submitted
information last August indicating some increased risk from the drug but that
other studies were contradictory. However, several members of Congress expressed
alarm and said they would hold hearings on the safety issues.
The FDA has come under fire in recent years for its
failures in protecting the public from dangerous drugs. Lawmakers quickly
reacted to the news, questioning whether Avandia further evidenced a breakdown
at the FDA.
Representative John D. Dingell, chairman of the House
Energy and Commerce Committee, noted that the FDA has known about the problem
for at least eight months. “What we don’t know is why diabetics and their
doctors haven’t been notified of the substantial risk to the heart from a drug
prescribed to protect the cardiovascular system.”
An editorial that accompanied the May 2007 study in
The New England Journal Medicine questioned why doctors would continue to
prescribe Avandia given the availability of alternative treatments with more
favorable risk profiles.
Avandia is used to treat Type 2 diabetes, the most common
form of the disease, which is linked to obesity and afflicts 18 million
Americans and 200 million people worldwide. This form of diabetes occurs when
the body does not make enough insulin or cannot effectively use what it manages
to produce. It is sold alone as Avandia and in combination with other drugs,
including Avandamet and Avandryl.
If you have suffered a heart
attack or heart failure and you took Avandia, please
contact us today to protect your interests.
CALL AND SPEAK WITH A LAWYER TODAY AT 713-529-1177
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years of experience, the lawyers of Thomas & Wan have the knowledge and
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emotional and financial difficulties faced by injured people and their families.
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