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Article
November 29, 1965

ANIMAL DRUG TERATOGENICITY: ITS APPLICATION TO MAN

JAMA. 1965;194(9):1007-1008. doi:10.1001/jama.1965.03090220063020
Abstract

An ad hoc committee of the Food and Drug Administration last year unanimously recommended that sale of meclizine, cyclizine and chlorcyclizine be on prescription and that a warning of their potential human teratogenic hazard be carried on labeling. That recommendation was based largely, if not entirely, on animal studies showing an association between drug administration to the pregnant female rat and the production of anomalies in the offspring. (Sweden had required such drugs to be available on prescription only but subsequently rescinded that action.)

This matter was considered again by an enlarged FDA ad hoc committee on April 22, 1965. The FDA has now officially announced the findings and recommendations of this latest ad hoc committee, which were (1) to leave on the market the overthe-counter products used for motion sickness; (2) to require a label warning of a potential teratogenic hazard for over-the-counter use; and (3) to convene the

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