Isotretinoin
Isotretinoin is a teratogen; there is about a 20–35% risk for congenital defects in infants exposed to the drug "in utero", and about 30–60% of children exposed to isotretinoin prenatally have been reported to show neurocognitive impairment. Because of this, there are strict controls on prescribing isotretinoin to women who may become pregnant and women who become pregnant while taking isotretinoin are strongly advised to terminate their pregnancies.
Isotretinoin
Isotretinoin was first marketed as Accutane by Hoffmann-La Roche. It sold well for many years, but in 2009, Roche decided to remove Accutane from the US market after juries had awarded millions of dollars in damages to former Accutane users over inflammatory bowel disease claims. The American College of Gastroenterologists has released a position paper stating that people with inflammatory bowel disease should not be precluded from having their acne treated with isotretinoin. It then became generic and as of 2017 was marketed under many brand names worldwide.
Isotretinoin is used primarily for severe cystic acne and acne that has not responded to other treatments. Many dermatologists also support its use for treatment of lesser degrees of acne that prove resistant to other treatments, or that produce physical or psychological scarring. Isotretinoin is not indicated for treatment of prepubertal acne and is not recommended in children less than 12 years of age.