Avandia
In May 2007, a study in the prestigious New England Journal of Medicine concluded that Avandia was linked to a greater risk of heart attack and possibly death. Avandia is used to treat Type 2 diabetes, which afflicts 18 million Americans, and occurs when the body does not make enough insulin or cannot effectively use what it produces. The U.S. Food and Drug Administration issued a "Safety Alert" urging diabetics taking Avandia to talk with their doctors to determine whether they should change medications.
In December 2007, additional research showed that Avandia could also increase the risk of liver failure, bone fractures and vision loss.
The FDA recently announced that it would consider whether to pull GlasxoSmithKline's (GSK) former top-selling drug, Avandia, off the market or allow it to stay on the market with stronger warnings after discovering evidence indicating that the drug may cause liver toxicity, resulting in liver failure and death.
This pronouncement comes after notable medical groups in the U.S. and Europe, including the American Diabetes Association and the European Association for the Study of Diabetes, asked doctors worldwide to no longer prescribe Avandia.
Thereafter, on Thursday, October 30, 2008, the consumer group Public Citizen specifically asked the FDA to ban the diabetes drug, indicating that in addition to increasing the risk of heart attack by 40%, there were many other life-threatening risks that far outweigh its benefits, including bone fractures and now the risk of liver toxicity. Public Citizen cited fourteen cases of Avandia-induced liver failure, twelve of which were lethal, that were discovered in the FDA Adverse Event Reporting System.
Although Avandia sales have fallen sharply since May 2007, Public Citizen said about 10,000 prescriptions are still being filled daily for Avandia. GSK said Avandia and a related product that combines Avandia with another diabetes drug recorded world-wide sales of $313 million in the third quarter of this year.
Not surprisingly, GSK continues to claim that Avandia is safe and effective when used appropriately. However, safer and more effective drugs for Type 2 diabetes including Glucophage and Glucotrol remain on the market.
Recently, in the Eastern District of Pennsylvania, the Federal Court has ruled that updated product warnings concerning Avandia may not have adequately warned users of heart attack and stroke. GSK argued, in part, that plaintiffs, who took Avandia after the 2007 black box warnings concerning the risk of heart failure, were adequately warned of the risk of heart failure. However, the court found that a reasonable jury might conclude that the 2007 label was not specific or direct enough.
At Pogust Braslow & Millrood, protecting our clients is our primary goal. We recognize that drug companies are under an obligation to warn about the known risks of their products. When they fail to do so, they may be held responsible for the injuries or deaths that are the consequence of their inaction.
If you or a loved one has suffered a heart attack, or a loved one has died of a heart attack while taking Avandia, you should immediately contact the attorneys at Pogust Braslow & Millrood, where Protecting Consumers Is Our Primary Goal. Just fill out this form, click here to send us an email or call us at (610) 941-4204.
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