Terminations of Pregnancy for Exposure to Oral Retinoids in South Australia, 1985–1993

Abstract

The oral retinoids, isotretinoin and etretinate, are highly teratogenic drugs which have been available in Australia since 1985 because of their unique effectiveness in severe cystic acne, psoriasis and other keratinization disorders. Only dermatologists can prescribe them, but in spite of strict guidelines by the manufacturers and the College of Dermatologists, exposed pregnancies have occurred. We attempted to determine the circumstances of exposure to these drugs for the 18 pregnancies terminated in South Australia in 1985-1993, using questionnaires to medical practitioners who notified the terminations under legislation. The main reason for their occurrence was the lack of compliance with the use of effective contraception by the women. In South Australia, some prescriptions of oral retinoids by unauthorized doctors have been dispensed during this period. Using statistics on prescriptions dispensed, an estimate was made of 1 termination of pregnancy for 319 courses of treatment for women with isotretinoin. Extension of guidelines for prescription and more detailed counselling in relation to the use of contraception are recommended. It is also suggested that doctors intending to recommend terminations obtain consent to discuss exposure with the dermatologists concerned, who may not be aware of the exposed pregnancy.

A risk management program aimed at preventing fetal exposure to isotretinoin: Retrospective cohort study

“…Although we continued to see fetal exposures after program implementation, the rate of fetal exposure in our population is significantly lower than the rates published in previous studies (3.1 to 3.5 per 1000 courses of therapy). 5,9,11 These published rates are 50% higher than those seen in our patient population.…”

The prescription of isotretinoin to women: is every precaution taken?

“…An increased rate of spontaneous abortion is also a recognized consequence of retinoid exposure, 3 and this further compounds the likely under-estimation of the number of pregnancies where drug exposure has occurred. While any pregnancy during treatment is undesirable, rates of terminations of pregnancy in the U.K. as a result of isotretinoin exposure are lower than comparable statistics from other countries 11,12 (Table 2), perhaps as a result of prescription of the drug being restricted to hospital specialists only. In the U.S.A., a survey of 124,216 women treated with isotretinoin revealed 402 pregnancies during treatment (3·4 pregnancies per 1000 treatment courses) and 132 pregnancies in the month following treatment.…”

A comparative review of the isotretinoin pregnancy risk management programs across four continents

“…There were 15 pregnancies in South Australia that were terminated due to isotretinoin exposure between 1985 and 1993 . Furthermore, a survey by Lee et al .…”