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Executive Summary

ACCUTANE AND BIRTH DEFECTS: NO NEW REPORTS HAVE BEEN RECEIVED since the recent round of publicity on the adverse reactions associated with the drug, Roche declared in a July 22 letter to FDA Commissioner Young. "There have been no new spontaneous reports of birth defects associated with pregnancy exposures to Accutane from physicians or patients in the last three months," the letter states. Submitted in response to a Health Research Group petition seeking more stringent regulation of Accutane (isotretinoin), the letter also questions interpretations of data by the FDA Division of Epidemiology and Biostatistics that predict hundreds of potential birth defects associated with the drug. Through April, the company had received eight reports of birth defects from the Centers for Disease Control and the California Birth Defects monitoring Program. Roche stressed that all were received before the widespread publicity on the adverse effects of Accutane. Such publicity, the letter states, "would clearly prompt both physicians and affected patients to report birth defect cases associated with Accutane if there were previously unreported cases." Therefore, the letter concludes, "the fact that there has not been any recent surge in the number of new cases strongly suggests that the estimates of pregnancy exposure . . . are grossly exaggerated." Estimates of 9,000 exposed pregnancies and 600 birth defects resulting from Accutane were projected by David Graham, MD, FDA Epidemiology and Biostatistics Division, at an April 26 Dermatological Drugs Advisory Committee open hearing. Graham extrapolated his estimates, the letter states, based on preliminary data from a Group Health Cooperative (GHC) study. The Roche letter cites a cautionary letter sent to Graham from GHC investigator, Herschel Jick, MD, Boston Collaborative Drug Surveillance Program. "No woman at GHC exposed to Accutane during pregnancy delivered a malformed child," Jick stated. "It seems to us that any projection from zero observed malformations at GHC to many hundreds nationwide must be highly speculative," he writes. To date, there have been 69 reports of birth defects associated with Accutane. FDA asked Roche in May to submit revised packaging and patient labeling and a time-table for sending out "Dear Doctor" letters and consent forms ("The Pink Sheet" May 30, p.6). Roche has complied, and is developing protocols for surveillance and dosage studies.

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