DOCTOR'S VIEW ARCHIVE

Accutane(isotretinoin) - Acne medicine linked to birth defects, depression and suicide

"Acne Drug Linked to Suicide Risk," was the headline over a Reuters story last this year that began: "The US Food and Drug Administration (FDA) issued a statement...advising physicians and consumers about reports of "depression, psychosis, and rarely suicidal thoughts and actions" related to use of the acne drug isotretinoin (Accutane)."

Isotretinoin (Accutane) is now commonly used to combat the cutaneous curse of adolescence, acne. Why?

The skin inflammation acne is in part due to increased secretion from the sebaceous glands in the skin with secondary irritation and subsequent scarring (keratinization).

Accutane decreases the secretions and size of the sebaceous glands, minimizing scarring from acne.

The FDA became particularly concerned about the psychological side-effects of Accutane after it received some two dozen reports of patients whose psychological symptoms improved after they stopped the drug, but worsened upon re-starting it. "To us that's an important clue that something might be occurring," said Jonathan Wilkin, director of the FDA's division of dermatologic drugs.

However, Accutane is not merely an anti-acne drug that "may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide." It has effects that can go well beyond the skin and psyche.

Do not forget that Accutane is a potent teratogen: an agent capable of causing human congenital malformations.

To quote the March of Dimes Birth Defects Foundation: "There is an extremely high risk of fetal malformations if pregnancy occurs while taking Accutane in any amount, even for short periods. Potentially all exposed fetuses can be affected. Birth defects include hydrocephaly (enlargement of the fluid- filled spaces in the brain); microcephaly (very small head); mental retardation; small and malformed ears and other facial abnormalities; and heart defects."

Accutane can cause these major malformations in the early weeks of pregnancy soon after conception, a time when many women may not yet know they are pregnant. Therefore, MedicineNet (and many other sources) recommend that:

  • Accutane must not be used by women who are pregnant, plan on being pregnant, or have a chance of becoming pregnant.
  • Abstinence or effective birth control methods should be used and pregnancy tests should be performed prior to starting treatment and repeated monthly during treatment.
  • Pregnancy should be avoided until at least one month after stopping Accutane. Nursing mothers should not use Accutane.
  • Any woman of child bearing age should seriously discuss potential side effects with her doctor before using Accutane.

Last Editorial Review: 2/4/2003