Accutane, Pregnancy, Abortion And Birth Defects - The Results

Anick Bérard, Laurent Azoulay, Gideon Koren, Lucie Blais, Sylvie Perreault, and Driss Oraichi.

Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective.

Br J Clin Pharmacol. 2007 February; 63(2): 196–205. Published online 2007 January 3. doi: 10.1111/j.1365-2125.2006.02837.x. PMCID: PMC1859978

The purpose of this study was to estimate the population-based incidence rates of pregnancy, spontaneous and elective abortions, and birth defects associated with isotretinoin use, and to determine predictors of pregnancy while on isotretinoin.

Isotretinoin is the most widely used teratogenic drug in North America. Teratogenic substances interfere with normal embryonic development. In the US, three out of every one thousand women of reproductive age are using or have used isotretinoin. The risk of fetal malformations in the general population is 3–5%, but it has been reported to increase to almost 30% in women exposed to isotretinoin during the first trimester of pregnancy.

This was a retrospective, cohort study done in Quebec. The researchers searched RAMQ (medical and pharmaceutical data), MED-ECHO (hospitalizations) and ISQ (births and deaths) databases for the period 1984–2002, and identified eight thousand six hundred and nine women between 13 and 45 years of age (average 26 years) with a first prescription for isotretinoin. Pregnancies, spontaneous and elective abortions, and birth defects were identified using procedure codes and medical diagnoses.

Subjects were followed from the time of their first prescription for isotretinoin during the study period until one month after the end of the treatment regimen if no pregnancy occurred. Where pregnancies occurred, the subjects were followed until the date of an elective or spontaneous abortion or stillbirth. In the case of live births, subjects were followed for three years.

Ninety of the study subjects became pregnant, an annual incident pregnancy rate during isotretinoin treatment of 32.7 per 1000 person-years of treatment. Of the 90 women who became pregnant while on the drug, 76 terminated the pregnancy (84%), three had a spontaneous abortion (3%), two had trauma during delivery resulting in neonatal deaths (2%) and nine had a live birth (10%). Among the live births, only one had a congenital anomaly of the face and neck (11%).

The predictors of becoming pregnant during isotretinoin treatment were lower socio-economic level and high use of health services. Using oral contraceptive while on isotretinoin had a preventive effect.

This study found that the rate of pregnancy in women while being exposed to isotretinoin was four times greater than what has been published to date; the rate of elective abortions is much higher than previously reported; and the rate of birth defects was lower. The researchers concluded that the pregnancy prevention programs currently in place have failed and more effective risk management strategies are needed.

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