Concerns raised over GSK drug24th May 2007
UK-based drug giant GlaxoSmithKline faces a wave of potential lawsuits in the United States after a study found that its diabetes drug Avandia raised the risk of heart attack.
The Food and Drug Administration (FDA), which approved Avandia in 1999, said it was aware of potential safety issues, although the company says it is confident that the drug is safe.
Scientists analysed the results of 40 trials of Avandia - also known as rosiglitazone - involving 28,000 people and concluded that 65% of deaths among diabetic patients could be attributed to heart disease.
Lawyers who bring product liability cases say they are fielding calls from Avandia users who are contemplating suing Glaxo, following the New England Journal of Medicine article.
Glaxo could face potential liability in the tens of billions of dollars, according to one lawyer. The comments hit the company's share price in London.
Another lawyer was quoted by Reuters as saying that his firm had been in touch with Avandia users and was considering whether to bring any suits. That law firm also represents thousands of plaintiffs in cases against Germany-based Merck & Co involving the withdrawn painkiller Vioxx.
An estimated six million people have taken Avandia in the United States since it was approved, but the FDA said it was not asking Glaxo to take any action in light of the findings.
But it said patients with known heart problems should consult their doctors about treatments for type 2 diabetes.
Officials said the results of studies on Avandia were conflicting, and the agency was still weighing up the findings carefully, and would publish its analysis soon.
Glaxo reached a settlement with the US authorities in 2004 over allegations that it withheld negative information about its antidepressant pill, Paxil.
As a result, it agreed to publish clinical trial results for some of its medicines on the Internet.
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Title: Concerns raised over GSK drug
Author: Luisetta Mudie
Article Id: 2940
Date Added: 24th May 2007