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August 24, 1994

Adverse Drug Reactions: Getting Information Back From medWatch-Reply

Author Affiliations

Food and Drug Administration Rockville, Md

JAMA. 1994;272(8):590-591. doi:10.1001/jama.1994.03520080032028

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In Reply.  —The concerns expressed by Drs Vogt and Byrns raise important access and cost issues that have been under discussion within the FDA since the announcement of the MEDWATCH program last June. Improving feedback to health professionals, one of the four goals of MEDWATCH, had already been selected as the element to receive specific attention during the next year. Thus, their letter is timely. We know that no adverse event reporting system can work effectively unless information flows both in and out of it, and we are troubled that the experience as described by Vogt and Byrns will discourage use of the system.It is important to recognize that once causality has been established, the FDA communicates new safety information to health professionals. This is done through labeling changes, "Dear Health Professional" letters, and the FDA Medical Bulletin. The Bulletin is sent to more than 1 million health professionals.

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