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CCHRINT Announces FDA Reported Psychiatric Drug Side Effects Search Engine
Date:8/4/2009

banning a drug).

It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.

Since the reform of the Prescription Drug User Fee Act (PDUFA) in 2007, ads for psychiatric and other drugs must include statements encouraging consumers to report adverse drug reactions to the FDA's MedWatch system--Adverse Events Reporting System (AERS). However, consumers or doctors attempting to access the AERS online were confounded by a system so complex that it was impossible to use. Although the FDA should have made the information collected readily accessible, it failed in that duty to the public. It took a computer programmer over 1,000 hours to decipher four years' worth of data to make this information available.

The programmer identified the main psychiatric drugs in the AERS, wading through quarterly reports of seven different reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication (diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each year from 2004-2006 and 2004-2008 to the FDA's MedWatch system.

Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists, other health care providers and consumers once those drugs are out in the consumer market, is fundamental to drug safety monitoring. Yet these reports have been frequently ignored or dismissed
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