Some Women Still Getting Pregnant While on Isotretinoin, an Acne Drug Tied to Birth Defects

Hundreds of pregnancies still occur every year among U.S. women taking an acne medication that carries a high risk of birth defects, a new study finds.

"While the number of pregnancies among patients taking isotretinoin is low, even 200 pregnancies is too high," said corresponding author Dr. Arash Mostaghimi. He is director of dermatology inpatient service and co-director of the Complex Medical Dermatology Fellowship Program at Brigham and Women's Hospital in Boston.

"We need to think about regulations that can reduce that number without being overly burdensome for patients and physicians," Mostaghimi added in a hospital news release.

The pregnancies are occurring despite a special restricted distribution program for isotretinoin (also known by its former brand name as Accutane), according to the researchers.

In 2006, the U.S. Food and Drug Administration (FDA) imposed a program called iPLEDGE for the drug. The program has strict requirements for patients, prescribing physicians and dispensing pharmacists.

This study found that the number of pregnancies in women taking isotretinoin fell after the program was implemented, but there are still hundreds happening each year.

The researchers analyzed FDA reports of pregnancy-related adverse events associated with isotretinoin from January 1997 through December 2017.

Reported pregnancies among women taking the drug peaked in 2006 (768 pregnancies) before settling into a range of 218 to 310 per year after 2011, according to the news release.

The researchers said that pregnancies, abortions and fetal defects all decreased after the implementation of iPLEDGE in 2006, but they still occurred.

Several factors other than iPLEDGE may be contributing to the decrease, including a national decline in teen pregnancy and increased use of long-term birth control and emergency contraception, the study authors suggested.

In a related study earlier this month, researchers found that a large proportion of patients taking isotretinoin experienced mental health issues, including anxiety, depression and suicidality.

"With mandated, monthly visits for iPLEDGE, we have an opportunity to improve screening for other side effects, such as mental health, in addition to identifying more effective ways to lower pregnancy rates," Mostaghimi said.

"iPLEDGE springs from the desire to protect newborns and women, but we should think of it as a testing ground for identifying the best system to reduce isotretinoin-related complications while maintaining access to an important drug," Mostaghimi concluded.

The report was published online in JAMA Dermatology.

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