Although the FDA's Adverse Event Reporting System (AERS) database has been in existence since 1969, more than half of the incidents in it were received in the past decade, according to an article published online March 28 in the Archives of Internal Medicine.These 2.2 million events represent a 1.65-fold increase from the prior decade, wrote Sheila Weiss-Smith, PhD, from the University of Maryland School of Pharmacy in Baltimore, and colleagues. "Report volume increased from 2000 to 2010 at a mean annual rate of 11.3 percent,” the authors continued.
AERS is a repository of passively reported adverse drug events designed as a safety net so the FDA can monitor all marketed drugs and detect serious safety problems. Weiss-Smith and colleagues sought to characterize the current reporting patterns.
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