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August 24, 1994

Adverse Drug Reactions: Getting Information Back From medWatch-Reply

Author Affiliations

Pharmaceutical Research and Manufacturers of America Washington, DC

JAMA. 1994;272(8):591. doi:10.1001/jama.1994.03520080032029

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In Reply.  —The experience reported by Drs Vogt and Byrns concerning their difficulty in obtaining adverse experience (AE) data from the FDA and clinically relevant details from the drug sponsors, and the frustration they express because "health care providers cannot easily access a database which could assist in managing... care" are understandable. However, they are the result of a misperception concerning the type of AE data submitted to drug sponsors and collected by the MEDWATCH program, and a misunderstanding of the purpose of the FDA's Voluntary Reporting System.Spontaneous AE reports that come to the drug sponsor, or to the FDA, are often incomplete and, with the exception of the small number of reports in which documented follow-up occurs, contain fragmentary data. Additionally, reports are frequently confounded by the use of concomitant medications, concurrent diseases, and the underlying medical conditions being treated. The data accumulated are not intended for case

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