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Isotretinoin and pregnancy
Journal of the American Academy of Dermatology
|May 1, 1984
Summary
Isotretinoin, used for cystic acne, poses significant teratogenic risks. Exposure during pregnancy resulted in high rates of spontaneous abortion or birth defects, including CNS and cardiovascular anomalies.
Area of Science:
- Teratology
- Pharmacovigilance
- Dermatology
Background:
- Isotretinoin is a widely used acne medication.
- Concerns exist regarding its safety during pregnancy.
Purpose of the Study:
- To assess the teratogenic risk of isotretinoin exposure during pregnancy.
- To evaluate the effectiveness of a specialty-based adverse drug reaction reporting system.
Main Methods:
- Data collected from the American Academy of Dermatology's Adverse Drug Reaction Reporting System (ADRRS) and the U.S. Food and Drug Administration.
- Pregnancy outcomes of women inadvertently exposed to isotretinoin were analyzed.
Main Results:
- Of 35 pregnancies with isotretinoin exposure, 83% resulted in spontaneous abortion or infants with birth defects.
- Common severe birth defects included central nervous system (microcephaly, hydrocephalus) and cardiovascular anomalies.
- Microtia or absence of external ears was also frequently observed.
Conclusions:
- Isotretinoin demonstrates a significant teratogenic risk in humans.
- Specialty-based reporting systems are valuable for identifying adverse drug effects.
- Physicians must thoroughly inform women of childbearing age about these risks.