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August 24, 1994

Adverse Drug Reactions: Getting Information Back From medWatch

Author Affiliations

University of Colorado Health Sciences Center Denver

JAMA. 1994;272(8):590. doi:10.1001/jama.1994.03520080032027

To the Editor.  —The Food and Drug Administration's (FDA's) MEDWATCH program represents a major advance in postmarketing surveillance.1,2 In order to sustain and promote reporting, however, a further step can be taken. Just as health professionals voluntarily submit information to medWATCH, health professionals should be able to obtain information from MEDWATCH as well.An example serves to illustrate this point. An otherwise healthy patient who was receiving a hypnotic drug and an antidepressant suddenly developed severe anemia (October 1993). The physician, concerned about the possibility of drug-induced anemia, requested help from a drug information center. The drug information pharmacist was not able to obtain any detailed information from either manufacturer on this adverse effect, other than the fact that isolated cases of bone marrow suppression had been reported. At the physician's suggestion, the pharmacist contacted the FDA in an attempt to learn more about the isolated cases of

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