Celgene Thalomid
Executive Summary
Two pregnancies in partners of thalidomide users that have occurred in the first year after launch did not violate requirements of System for Thalidomide Education and Prescribing Safety Program, Celgene says. Conception occurred 35 days and 65 days after discontinuation of treatment. Thalomid labeling requires contraception for one month prior to therapy, during therapy and for one month following therapy. Celgene said it immediately reported the cases to FDA. FDA presented Thalomid as an example of managing postmarketing risk of drugs at its Science Forum Feb. 15