Are there any contraindications to the use of oral isotretinoin?

Isotretinoin is classified as a pregnancy category X drug, which means that it is absolutely contraindicated for patients who are pregnant. Between 1982 and 1989, the manufacturer received 151 reports of patients who carried their fetuses to term. In 47% there were significant congenital malformations, with most being cardiovascular, craniofacial, or central nervous system in nature.

In 2002, an intensive program (System to Manage Accutane-Related Teratogenicity, or SMART) consisting of counseling, consent forms, videotapes, written information, utilization of two forms of effective contraception, and two negative urine or serum pregnancy tests (to include one within the first 5 days of the menstrual period before implementing therapy) was undertaken. The program was not successful in preventing pregnancies while on therapy. In 2006, the FDA has implemented a very controlled restrictive program called iPledge to reduce the access of this drug. In this new program, both doctors and pharmacists are required to register and use a website to prescribe this drug. This new program is so restrictive that it is actually easier to buy a firearm in most states than it is to prescribe oral isotretinoin.

Patients who become pregnant while taking the drug should consider the desirability of continuing the pregnancy. Health care providers who are not knowledgeable about the proper way to administer and monitor oral retinoids should never use this class of drugs. Relative contraindications for oral retinoid therapy include patients with pseudotumor cerebri, inflammatory bowel disease, hyperlipidemia, hepatitis, and those who are children.