RAPS – Regulatory Updates: Adverse Event Reports Up Dramatically in Past Decade – April 21, 2011

April 21, 2011 By


Adverse drug reactions (ADRs) reported to the US Food and Drug Administration (FDA) have increased dramatically over the past decade, according to new research from the University of Maryland School of Pharmacy. The report examines FDA’s adverse events data since 1969 and found that 55% of all ADRs had been reported between 2000 and 2010. Lead researcher Sheila Weiss Smith cautioned that the reports do not accurately reflect the actual number of reactions as many go unreported, and also emphasized what she feels is the findings’ most important takeaway: the need for better quality reporting. Researchers found many reports lacked needed information, including one-third that failed to document the patient’s age, a critical piece of data. “Without ages, you have to throw out those reports,” said Weiss Smith. http://www.raps.org/newsroom/latest-news.aspx