FDA to Take Second Look at Avandia

The books have again been opened on Avandia. In a shocking move by the Food and Drug Administration, the notorious diabetes drug—severely restricted in 2010 after being linked to heart problems in thousands of users—will get a second chance on American pharmaceutical shelves in what could be a massive triumph for the drug company GlaxoSmithKline.

Dr. Steve Nissen, the chair of cardiovascular medicine at Cleveland Clinic, says he is disgusted with the FDA’s move. The first individual to warn the public about the disturbing side effects of Avandia, Dr. Nissen is recognized as a voice for drug integrity and safety in the medical community. In this case, he believes the FDA’s actions have more to do with the embarrassment of the agency than a desire to protect the consumer.

It has been estimated that between 60,000 and 20,000 diabetes sufferers in the United States experienced heart attacks and deaths as a result of Avandia usage. In 2007—after Avandia had been approved for eight years—Dr. Nissen published his study suggesting that the heart attack risk for Avandia users was increased by more than 40 percent. An ensuing Senate investigation led to the drug being restricted in the United States so that only extreme diabetes patients can opt to use it and take their chances with the side effects. Thousands of plaintiffs have received compensation from the pharmaceutical company GlaxoSmithKline for heart complications suffered.

Now, the FDA is re-examining the findings which led to Avandia being all but outlawed. In a six-year review ordered by the FDA, experts at Duke University found room for doubt as to whether the drug definitely impacts heart health. Critics question the independence and integrity of this review, which was paid for by GlaxoSmithKline.

With our years of experience fighting on behalf of the victims of defective drugs, we at The Senators Firm understand the complex issues surrounding these cases. There are laws in place written to protect consumers from powerful companies that achieve financial gain at the expense of customer safety. If you or someone you love has experienced cardiovascular complications while taking Avandia, our firm of California lawyers may be able to help.Contact us today for a free, confidential case evaluation.