Earlier this week most members of a Food and Drug Administration medical advisory committee reported that the side effects of Avandia increase the risk of heart attack when compared to older drugs, yet a majority of the committee voted to allow GlaxoSmithKline’s diabetes drug to remain the market.
The FDA advisory panel met for two days, pouring over numerous studies that highlighted the risk of Avandia causing heart problems so that recommendations could be made whether the agency should issue an Avandia recall or take other steps to protect consumers.
Avandia has come under harsh criticism in recent months by a number of experts, including 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 Critics have argued that Avandia should be withdrawn and there is no reason to put patients at risk with the drug when Takeda Pharmaceuticals’ Actos is a an alternative, which does not carry the same heart attack risk as Avandia.
The FDA approved Avandia (rosiglitazone) in 1998 to treat type 2 diabetes by helping control blood sugar levels. This injury causing and potentially life threatening drug has been used by millions of diabetics, but sales have plummeted in recent years as concerns have mounted about the risk of serious and potentially life-threatening heart risks with Avandia.
After reviewing the evidence, 18 of the 33 expert panelists said Avandia appeared to be more dangerous than older, established diabetes drugs, 6 said no, and 9 abstained due to lack of evidence.
However, when the panel was asked to vote on taking action, only 12 voted in favor of an Avandia recall, with 10 voting to add stronger warnings and to restrict its use. Seven voted to just add new label warnings and three voted to do nothing. One member abstained.
The vote came in the wake of a flurry of allegations that GlaxoSmithKline has attempted to cover up the personal injury caused by Avandia. A former FDA drug safety reviewer has testified that Glaxo knew about the heart risks associated with their drug as early as 2001, although the public was not made aware of the Avandia heart problems until 2007. An independent study published in New England Journal of Medicine in May 2007 reported that Avandia may increase the risk of heart problems by 43%.
On Monday, a letter was sent to FDA Commissioner Margaret Hamburg by the U.S. Senators Max Baucus and Charles E. Grassley, who lead the powerful Senate Finance Committee and included transcripts of GlaxoSmithKline e-mails suggesting that they knew and were concerned about Avandia heart risks as early as 2000.
Earlier this year, the same senators released a U.S. Senate report which determined that GlaxoSmithKline knew that Avandia caused heart problems, but failed to inform the U.S. drug regulators. The Senate report also revealed that some FDA drug safety reviewers have been calling for a recall for Avandia since 2007.
The FDA is conducting an ongoing safety review of Avandia, rather than follow the precautionary principle we have advocated in the past. Although the FDA is not required to follow the recommendations of its advisory committees, it often does. The on-going clinical trials involving Avandia should be shut down. In our view it is unethical to continue due to the know risk of personal injuries and deaths caused by Avandia.
The clinical trials, known as TIDE, are being conducted with people across the globe, and some have criticized the company for heavily recruiting for the test in third world countries where patients are more probably unaware of Avandia side effects.
India has recently announced that it is banning GlaxoSmithKline from farming for subjects among its population of more than one billion people. The Drug Controller General of India halted the recruiting on June 30, citing increasing studies showing Avandia health risks.
You would hope the United States would not be outclassed by the Government of India.
On July 14, 2010, reports were leaked to the media that GlaxoSmithKline had agreed to settle Avandia lawsuits filed by about 10,000 out of an estimated 13,000 people who claim that they or family members suffered injuries as a result of the drug makers failure to warn of the risk of Avandia heart attacks.
If you or your friends and family have been harmed by taking Avanida or any other dangerous drug please call 1.888.777.1776 or email us to discuss your case with an informed attorney. Please be sure to provide you telephone number. We will be happy to report on the Avandia litigation. All calls are guaranteed confidential. For all personal injury and wrongful death clients: no recovery, no fees, no costs.
Onward,
Richard Alexander
