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Glaxo failed to warn of diabetes drug risk: lawsuit

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Reuters
June 20, 2007

NEW YORK (Reuters) - The widow and son of a Texas man who was taking a GlaxoSmithKline Plc diabetes drug at the time of his fatal heart attack has sued the drugmaker, claiming that it failed to warn of the drug's heart risks, according to court papers.

The claim involves rosiglitazone, which is sold under the brand names Avandia and Advandamet. Investors have been bracing for a flood of litigation against Glaxo after a widely publicized medical report last month suggested that Avandia increases the risk of heart attack and death.

The lawsuit was filed on Tuesday by relatives of Larry Alan Stanford in the U.S. District Court for the Eastern District of Texas. Stanford was taking Advandamet, which combines Avandia with another commonly prescribed diabetes medicine.

"Glaxo knew or should have known that its rosiglitazone drug greatly increased plaintiffs' risks of having a heart attack and/or other negative cardiovascular consequences or of causing sudden cardiac death," the lawsuit said.

Stanford, who was 60, died on the very day that a report was published in The New England Journal of Medicine raising the possibility of the increased heart attack risk posed by the widely used diabetes medicine.

Glaxo has been highly critical of the methods used by Cleveland Clinic cardiologists in analyzing the data that led to the journal report, and has insisted that Avandia is safe when used according to the prescribing information on the drug's label.

Glaxo was not immediately available to comment.

The suit charges that Glaxo was aware of the heart risks associated with the diabetes medicine, which had sales of $3.2 billion last year, but was negligent in its failure to warn the public, instead marketing it as safe and effective.

"After defendant Glaxo became aware of the risk of ingesting rosiglitazone, however, defendant Glaxo failed to communicate to plaintiff and/or the general public, that ingestion of this drug could cause a person to have a heart attack and/or stroke ..." the suit charges.

The claims appear to mirror those in many product liability lawsuits involving Merck & Co's withdrawn pain drug Vioxx. Merck is facing thousands of lawsuits that claim it knew of the drug's heart dangers long before the medicine was withdrawn, but hid them from the public, putting profit above patient safety.

A major difference here is that Avandia is still available and being vehemently defended by its maker, while Merck voluntarily took its drug off the market after one of its own studies revealed it to increase heart attack risk.

The suit against Glaxo, which requests a trial by jury, is seeking punitive and compensatory damages as well as legal costs and funeral expenses.

"I believe the evidence will show the company knew there were problems with Avandia, but decided to keep on selling it to Larry and others." the Stanford family's attorney, Stephen Drinnon, said in a statement.



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