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FDA WORKING GROUP EXAMINING EFFECTS OF INCREASED RETIN-A USE, INCLUDING TERATOGENIC POTENTIAL; INVESTIGATOR PREDICTS FILING FOR ANTI-WRINKLING IN 1989

Executive Summary

FDA has formed an internal working group to examine the "implications of the increasing usage" of Ortho's Retin-A, including the potential for teratogenicity, FDA Center for Drug Evaluation and Research Director Carl Peck, MD, told a Dec. 7 seminar for agency staff. One result of the growing use of Retin-A (tretinoin) as an anti-wrinkle agent, Peck said, is that the drug is "being placed on parts of the body that are known to have a high absorption." FDA is questioning whether this practice might "increase the body burden so that, in the course of conception or pregnancy, blood levels of a sustained nature would be high enough to cause a teratogenic effect," Peck said. Retin-A is a derivative of vitamin A, which is a known teratogen. In addition to assessing the potential risks from the increased use of Retin-A, the working group will also consider what kind of studies are necessary to evaluate the potential for serious adverse effects from the drug. "This development in retinoid usage has stimulated a lot of thinking," Peck said. However, he noted that "the knowledge base is not rich enough for us to simulate or anticipate the outcome [from high absorption levels of the drug in a large population]." Negative reactions to Retin-A have been restricted to the skin, John Voorhees, MD, University of Michigan Medical Center, told a Dec. 5 press conference at the American Academy of Dermatology's annual meeting in Washington, D.C. These reactions include peeling, break outs, and dry patches in the "vast majority" of patients who use the treatment in "an aggressive way," the Retin-A investigator noted. Voorhees said he has not seen any data suggesting that the drug will be harmful on a long term basis and that he does not hesitate to recommend treatment for "fairly young women." Patients who decide to enter Retin-A therapy for treatment of photoaged skin face a "lifetime commitment" to using the drug, according to Voorhees. After an initial two-year period of gradually building up both the concentration of the cream and the application rate, patients will probably be able to reduce their usage to two to three times a week, Voorhees maintained. Ortho's NDA to support an anti-wrinkling indication for Retin-A will be ready for submission to FDA "within the next year," Voorhees indicated. "A multi-center trial in the U.S. has been done in about 14 medical schools," Voorhees said. "This data is being accumulated and sometime, as I understand it, within the next year or so this will be submitted to the FDA for their approval." He noted that results of his 22-month study will be submitted for publication in a peer-reviewed medical journal in early 1989.
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