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The Journal of New Drugs, 1965; 5:193-198
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A Controlled Retrospective Survey In Evaluation of Teratogenicity

C. A. Bunde Ph.D., M.D.1 and H. M. Leyland Ph.D.2

1 The Wm. S. Merrell Co.
2 The Wm. S. Merrell Co., Cincinnati, Ohio.

We have presented a method for a controlled retrospective evaluation of marketed drugs used in pregnancy. This method has been applied in the evaluation of a drug used almost exclusively during the first trimester of pregnancy as an antinauseant (Bendectin®); no evidence of adverse effect on the pregnancy or infant has been found. The method has also been used to determine whether any risk to the pregnancy or baby occurred from an anorexic agent taken during pregnancy (Tenuate®). To date, no evidence of adverse effect has been found with this drug. Analyses of data from both studies indicate satisfactory control of variables. Variations of the methodology should be applicable to other retrospective surveys.


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