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How did Ketek, Avandia and Vioxx Receive FDA Approval?


The Food and Drug Administration (FDA) remains under fire for approving drugs with demonstrated serious side effects and for acting as a protector of big pharmaceutical companies instead of the public.

More than 3 years after Ketek was put on the market, the FDA still faces questions about why this drug was ever released to the public. Reports clearly indicated potentially deadly adverse effects from Ketek. Even more alarming was the fact that one of the doctors involved in the study falsified data. Even though the FDA knew the information they received was falsified, Ketek was approved nonetheless. To date, 53 people who took the FDA approved drug have suffered liver failure. Of those, at least five have died.

In addition to Ketek, other drugs fast tracked by the FDA, have been linked to questionable approval practices. On June 6, 2007, a medical expert testified before Congress that he notified GlaxoSmithKline as early as 1999 of Avandia’s heart risks. He further testified to receiving legal threats from executives at the company if he went public with this information. Avandia, an FDA approved diabetes drug, has been linked to increased heart-related death.

Merck, the manufacturer of Vioxx, has been defending its previously FDA approved drug Vioxx for more than 2 years now. Recently, a jury in Atlantic City, NJ found that Vioxx contributed to an Idaho postal worker’s heart attack and awarded $47.5 million in damages. The jury assessed $27.5 million in punitive damages to punish Merck for egregious conduct in the marketing of Vioxx. The jury was unanimous in finding that Merck was irresponsible, and had failed to warn both doctors and patients of the dangerous side effects. In addition, the jury found that Merck had committed consumer fraud by intentionally concealing, suppressing or omitting vital safety information about Vioxx. Amazingly, the FDA and Merck are still considering the return of this defective drug to the market.

Individuals who have been injured after taking Ketek, Avandia or Vioxx can contact attorney Brian Goldstein. Goldstein is an attorney who is a former Board Certified Surgeon and heads up the mass tort department at Cellino & Barnes.

For more information, visit Cellino & Barnes website at or contact attorney Brian Goldstein at 1-800-483-2050.


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