Federal drug regulators have launched an investigation into the actions of GlaxoSmithKline to determine whether the drug maker illegally hid information about the side effects of Avandia, its beleaguered diabetes drug that has been linked to an increased risk of heart attacks.
According to an August 12 story in TIME magazine, FDA Deputy Commissioner Joshua Sharfstein indicated that the agency has launched a probe into what GlaxoSmithKline told the FDA drug safety reviewers about Avandia health risks. The probe follows the discovery of documents that indicate company officials had evidence that Avandia increased the risk of heart problems by 30% to 43% eight days before it told FDA that its own research did not support evidence for Avandia heart problems at a May 16, 2007 meeting.
The meeting came five days before a study was printed in the New England Journal of Medicine that found that Avandia carried a 43% increased risk of heart attack.
Avandia has come under harsh criticism in recent months by a number of experts, including some FDA drug safety reviewers, who have estimated that Avandia may be responsible for more than 100,000 heart attacks and deaths since it was approved. Critics have argued that an Avandia recall should be issued, as there is no reason to put patients at risk with the drug when there are alternative treatments that do not appear to carry the same heart attack risk as Avandia.
Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted following the allegations of an increased risk of heart attacks and congestive heart failure .
Many analysts say that Avandia is effectively a dead product after an FDA advisory committee agreed that it increased the risk of heart attacks and death last month. Although the committee did not call for a recall of Avandia, the FDA may still decide to do so despite to protect consumers.
Earlier this year, a Senate report was released that criticized GlaxoSmithKline for intimidating doctors who spoke out about Avandia side effects and for failing to adequately warn users about the risk of a heart attack from side effects of Avandia. In addition, at a House drug safety hearing, several lawmakers pressed FDA with questions on why such a recall of Avandia has not yet occurred.
In July, FDA halted enrollment in new clinical trials that would compare the health risks of Avandia with those of Actos, a competing drug by Takeda Pharmaceuticals. Critics have called the trials unethical because they could be knowingly exposing human test subjects to potentially fatal drug side effects. They also criticized GlaxoSmithKline for recruiting heavily in third-world countries. The FDA has said that those already enrolled can stay in the testing as long as the company revises its disclosure materials to ensure that participants are fully informed about the risk. It is unclear whether it will allow additional subjects to be enrolled or whether it will ultimately cancel the drug trials.
GlaxoSmithKline faced about 13,000 Avandia lawsuits filed by plaintiffs who accuse the company of failing to warn patients that of Avandia heart attack risks. Last month the company announced it had settled about 10,000 of those Avandia suits.