Avandia, a treatment for type 2 diabetes, was once the second-best-selling drug of GlaxoSmithKline (GSK), but sales have slipped as doctors and patients became concerned about the drug’s heart attack risks. Now, the US Senate has released a report saying that GSK sought to intimidate independent scientists who spearheaded critiques of the drug and tried to misrepresent medical data to conceal risks. And The New York Times reports that the FDA is considering removing the popular but potentially deadly drug from the market. The Times claim comes from internal, confidential reports within the agency that recommend the drug be removed from the market. One of the reports says 300 heart failures a month could be prevented simply by switching people to a different diabetes drug, Actos. One report simply recommends that “Rosiglitazone [the active ingredient in Avandia] should be removed from the market.”
Despite evidence that Avandia may be to blame for 83,000 excess heart attacks over eight years, the agency is not in complete agreement that the drug is unnecessarily dangerous. Apparently, there are multiple conflicting opinions within the agency about the safety profile of Avandia. FDA scientists have scheduled a meeting for later this year to resolve the dispute and make definitive recommendations about the drug.
The FDA may be feeling pressure to do something about this dangerous pharmaceutical drug. On February 20, the US Senate issued the results of its two-year investigation into GSK’s response to safety concerns about Avandia. The report uses very strong language to criticize GSK’s handling of the drug. In addition, many are using Avandia as a case-in-point to level criticism against the agency itself. The Senate’s report notes that the officials who are in charge of monitoring drugs after approval are “under the thumb” of the officials who approved the drug in the first place and have a vested interest in ensuring that the drugs be seen as safe. The Senate recommends that the agency should give post-market surveillance greater independence from other FDA officials.
The FDA issued its own statement about Avandia on February 22, stressing that guidelines for the drug’s use have not changed and that people should not stop taking Avandia without first talking to their doctors.
In its reply to the Senate report, GSK denies that it has done anything wrong. The report said that it “welcomes and supports open and independent scientific debate about its products.” It also adds that 164 independent clinical trials have not shown an association between Avandia and heart attacks. However, as more and more information becomes available, it all seems to point to one conclusion: Avandia increases the risk of heart attacks. In its report, the Senate claims GSK knew the risks, but sought to suppress them.
If you have been injured or lost a loved one due to a dangerous prescription drug, the lawyers at Robert W. Kerpsack CO., LPA can help. Please call or email us today to schedule a free initial case evaluation.