PEDIATRICS Vol. 57 No. 3 March 1976, pp. 419-421
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Podophyllum–A Dangerous Laxative

Gladys Rosenstein M.D.1, Herman Rosenstein M.D.1, Martha Freeman M.D.1, and Nathan Weston B.S. (Pharm), M.Ch.E.1

1 Food and Drug Administration, Bureau of Drugs, Division of Metabolism and Endocrine Drug Products, Rockville, Maryland

A physician asked the Food and Drug Administration (FDA) for information regarding podophyllum. He had under his care an infant born with phocomelia manifested by bilateral absence of the radii. During her pregnancy, the child's mother had occasionally taken a laxative which contained podophyllum as one of its active ingredients. This inquiry led to an intensive search for available information on this subject. The discussion below is a summary of this information. From the data it was determined that podophyllum is too toxic a drug to be used as a laxative, especially since much safer laxatives are available.

The FDA Advisory Review Panel on Over-the-Counter (OTC) Laxative, Antidiarrheal, Emetic and Antiemetic Drug Products, in a recently completed independent evaluation, similarly concluded that podophyllum resin is an unsafe laxative.




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