FDA Hastily OKing Risky Drugs

...warn experts. But the public may be OK with that
By Evann Gastaldo,  Newser Staff
Posted Sep 5, 2012 10:50 AM CDT
FDA Hastily OKing Risky Drugs

The FDA's commissioner has been touting the agency's speedy approval of new medicines—but it has brought risky drugs to market, according to two drug-safety experts. Specifically, Thomas J. Moore and Curt D. Furberg found problems with cancer drug Caprelsa, multiple sclerosis drug Gilenya, and stroke prevention drug Pradaxa, the Wall Street Journal reports. "These examples raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered," they write in the Journal of the American Medical Association.

Caprelsa is "sufficiently toxic that overall survival [was] not different from that achieved with placebo," the authors write. Gilenya has "seven major safety issues," including negative effects on heart rate. And Pradaxa, an anticoagulant, has been linked to dangerous bleeding. An FDA director points out that the public wants expedited drug approval: "I'd like to stress that where there are unmet medical needs, the public has told us they are willing to accept greater risks," she says. "The cancer community in particular says we haven't used accelerated approvals enough." The FDA OKed 35 drugs last year, the second-most in a decade; 16 of them underwent an abbreviated review. (More FDA stories.)

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