ISOTRETINOIN IN CHILDBEARING WOMEN - LACK OF COMPLIANCE WITH WARNINGS

Background. Despite prominent warnings, pregnancies continue to be rep orted in women exposed to isotretinoin. Patients and methods. We repor t results of the analysis of 318 questions asked to pharmacovigilance structures in France from 1987 to 1995 because of an exposition to iso tretinoin during the risk period and of a prospective inquiry concerni ng isotretinoin prescription in women conducted among pharmacists. Res ults. These 318 pregnancies began during the month after Roaccutane(R) withdrawal (n = 104, 33 p. 100), during Roaccutane(R) treatment (n=16 3, 51 p. 100) or before Roaccutane(R) treatment (n = 51, 16 p. 100). O f the 167 women with pregnancies conceived during treatment with isotr etinoin (n = 104)) or during tile month after its discontinuation (n = 633, contraception was not prescribed in 28 (15 p. 100) or prescribed but with poor compliance in 109 (60 p. 100). Pregnancy was terminated voluntarily in 199 women (81 p. 100). In the 173 women who were inter viewed in pharmacies, 49 (28 p. 100) did not use contraception and amo ng them contraception was prescribed in only 59 p. 100. Only 14 p. 100 had received full information about isotretinoin and pregnancy. The t eratogenic effects of isotretinoin were known by 98 p. 100 of the wome n and the need of a contraception during treatment and for one month a fter discontinuation by 70 p. 100. Discussion. Insufficient compliance with warnings is the main reason for pregnancies in women receiving i sotretinoin therapy. A pregnancy prevention program is needed before p rescription to ensure comprehension and to obtain informed consent of patients.