GlaxoSmithKline's (GSK) diabetes drug Avandia once again captured headlines Monday morning after two new studies linked it to heart attacks and other cardiovascular complications. The authors of the studies say the results should prompt U.S. regulators to pull the drug from the market, Bloomberg reported.
According to an analysis by a drug-safety reviewer at the Food and Drug Administration, almost 50,000 elderly Americans died, suffered strokes or developed heart failure after taking Avandia instead of a rival medicine in the period since the treatment was approved in 1999. A second study published in the Journal of the American Medical Association and the Archives of Internal Medicine, from the scientists who first raised the alarm about Avandia, found one of every 52 patients taking the drug was harmed.
This is hardly the first time Avandia has been in the news for health risks. It was first linked to heart complications in 2007, and since then, many people have lobbied to have the drug pulled off the market, including two U.S. senators. Moreover, many called for the halt of an ongoing safety study of the drug, which was approved by the FDA. The study, called TIDE and which compares Avandia to competing drug Actos from rival firm Takeda Pharmaceutical, has been described as "unethical and exploitative" of patients.
Some hope these latest studies may finally prompt the regulatory authority to act, Steven Nissen, lead author of the second study told Bloomberg -- especially considering that there are safer alternatives such as Actos on the market. Still, GlaxoSmithKline is maintaining its position that its internal analysis of Avandia, as well as several observational ones, does not agree with the studies.
Sales of Avandia topped $2.6 billion in 2006 but fell to $1.2 billion in 2009 after the FDA added a label warning regarding the elevated cardiac risk.
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