Study: Spike in drug withdrawals coincides with FDA safety initiatives

08/21/2014 | MedPage Today (free registration)

A study by University of California, San Francisco, researchers counters the notion that the 1992 Prescription Drug User Fee Act encouraged the FDA to approve drugs in the absence of appropriate safety data, as researchers asserted in the journal Health Affairs. This new analysis of the same data found that warnings and withdrawals started to spike in 2005, after Merck's Vioxx was withdrawn, and have been more frequent than in the 1996-2004 period. The spike coincides with the "launch of FDA initiatives to strengthen drug safety surveillance, particularly postmarket reporting," the researchers wrote in JAMA Internal Medicine.

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