A study on the effectiveness of US Food and Drug Administration medication reporting policies has generated a new debate on the effectiveness of the FDA policies.
The prestigious Archives of Internal Medicine just published an article written by Abby Powers, Pharm. D. and Elliott Cook, Pharm. D. of the Lake Erie College of Osteopathic Medicine School of Pharmacy.
Since the article was released Monday on the Archives web site, the story has been picked up by the New York Times and other publications.
Since 2007, federal law requires the FDA to review adverse drug reports bi-weekly and issue a quarterly report on any new safety information or potential signal of a serious risk. Dr. Powers and Cook studied the quarterly reports between 2008 and 2010. They determined that half of the reported risks resulted in label changes, which meant the drug manufacturer had to report the risk on the medication, and in at least one case, the drug was removed from the market.
They noted that concern exists because the FDA does not recommend physicians take action on the potential signal of risk in these quarterly reports. According to the authors, this leads to confusion among health care providers. “It is time we better recognize the importance of these signals for the safety of the public even if they are just a “potential” signal,” the authors concluded.
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