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FDA Advised to Limit Accutane Prescriptions; Dermatology Panel Rejects Idea Of Taking Acne Drug off Market
[FINAL Edition]
The Washington Post (pre-1997 Fulltext) - Washington, D.C.
Author: Michael Abramowitz
Date: Apr 27, 1988
Start Page: a.01
Section: A SECTION
Text Word Count: 1031

Rejecting a proposal to remove the drug from the market, members of the panel suggested steps designed to ensure that Accutane is not taken by pregnant women. They include limiting the number of physicians who can dispense Accutane, permitting only certain patients to receive it, requiring high-risk female patients to receive a second opinion before getting the drug and forcing doctors to gain certification before being allowed to prescribe it.

Much of the day's hearing, which included graphic slides of both the effects of severe cystic acne and of birth defects associated with the drug, was devoted to a controversial study by FDA scientists indicating that the damage wrought by Accutane has been much more extensive than previously thought.

Dr. C. Carnot Evans, a top FDA official, said that while the FDA invited pediatricians, birth defect experts and others to advise the panel yesterday, the dermatological drugs advisory committee was reviewing Accutane because "it is a drug for dermatologists."

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