Dermatologist Prescribes Acne Medication Leading to Fetal Defects

This pediatric dermatology case involves a sixteen-year-old female who was treated with isotretinoin (Accutane) for acne leading to significant birth defects in her child. The young woman was being managed on less potent acne agents for two years until her acne began to persist. At this time, her dermatologist recommended she take an oral medication that worked systemically to treat her acne. The dermatologist asked the patient if she was sexually active, in which she truthfully answered yes. However, the physician did not ask about oral contraception or barrier use. Additionally, a pregnancy test was never ordered prior to initiating therapy. Six months after starting isotretinoin, she visited an OB/GYN due to missed periods and a positive, at-home pregnancy test. A pregnancy test in the office confirmed she was two months pregnant. Upon obtaining a medical history, the OB/GYN found out that she was prescribed isotretinoin, which warranted an emergent ultrasound. The ultrasound revealed significant defects in the developing fetus including facial deformities, hypospadia, and cardiac anomalies. Isotretinoin was immediately terminated. Six months later, the child was born with mental retardation as well as hearing and visual deficits.

Question(s) For Expert Witness

Did this dermatologist meet the standard of care, and what should have been done before prescribing this acne medication?

Expert Witness Response

This dermatologist did not inform the patient of a major isotretinoin side effect, teratogenesis. Isotretinoin is a Category X medication, meaning it has been proven to cause significant birth defects in the developing fetus. Some of the birth defects associated with isotretinoin include heart defects, craniofacial abnormalities, cranial nerve palsies, absent cerebellar vermis, and mental retardation. Before prescribing this agent to any female, a physician must do a urine beta-hCG level (pregnancy test). Females should have periodic pregnancy tests throughout their treatment. Additionally, it is important to educate on contraception. Two effective forms of birth control (or complete avoidance of sexual intercourse) must be used for one month before starting isotretinoin, during use, and for 1 month after stopping this drug. After 2005, only patients enrolled in the iPLEDGE program could obtain and use isotretinoin. Patients need to register with iPLEDGE and view a video at their doctor's office before receiving their prescription. Only physicians enrolled in iPLEDGE may prescribe isotretinoin, and only pharmacies enrolled in the program may dispense it.