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Pradaxa Among Drugs Subject to Quick FDA Clearance, Now Endangering Public

Filed September 5th, 2012 Laurie

The blood thinner, Pradaxa, as well as drugs used to treat cancer and multiple sclerosis were permitted to go on the U.S. market without the proper safety analyses, thanks to the Food and Drug Administration’s efforts to speed up approval for new medicines, according to two drug-safety experts.

An article written by Thomas J. Moore and Curt D. Furberg was published Wednesday in the Journal of the American Medical Association stated that the agency’s attempt to rush the process may have compromised the safety of many prescription drugs. The article highlighted an MS drug that causes heart problems and many other adverse events, as well as a blood-thinning drug linked to bleeding that is difficult to treat.

The agency approved 35 innovative medicines in fiscal 2011, and 16 of those received some sort of shorted review or expedited approval. Pradaxa, for instance has been linked to hundreds of deaths stemming from Pradaxa traumatic bleeding, including brain hemmorhages and Pradaxa gastroinestinal bleeding.

Janet Woodcock, director of the FDA’s center for drug evaluation and review, said medical groups and the public have been urging the agency to move faster, not more cautiously.
“I’d like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks,” Dr. Woodcock said. “The cancer community in particular says we haven’t used accelerated approvals enough.”

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