Reports of depression among people with acne are common, and at least one study suggests people with this arguably disfiguring skin condition struggle with more mental health issues than patients with epilepsy. When a patient with acne uses the commonly prescribed and highly effective drug isotretinoin (Accutane), the positive results, which include a boost in confidence, cannot be underestimated. However, for more than three decades, this drug has also had a reputation for being dangerous to female patients who become pregnant while using it. Not only do women face higher rates of spontaneous abortion, but babies exposed to it while in the womb may be born with severe birth abnormalities.

To prevent these tragic outcomes, strict pregnancy prevention guidelines are in place for women who are prescribed the drug, yet a new Canadian study suggests many women and their doctors are failing to follow the rules. Up to half the women taking the drug do not comply with the regulations, the researchers discovered.

The Food and Drug Administration first approved isotretinoin in 1982, and one year later Canadian regulatory authorities followed suit. The drug is in a class of medications called retinoids, which work by activating genes that help skin shed dead cells and renew itself. Widely used to treat severe and scarring cystic acne, the drug is usually taken twice a day for four to five months at a time. Reviews on suggest isotretinoin is not only effective but beloved by those who have used it — even those who have suffered side effects, including chapped lips, dry eyes, joint pain, and hair loss.

“For me, the side effects were worth getting rid of the intense psychological pain and destroyed self-esteem acne was causing me,” wrote one user.

Though the drug appears to benefit many people, it is quite toxic. In 1988, the original manufacturer responded to concerns about birth defects resulting from use of isotretinoin by creating strict guidelines to prevent fetal exposure. Female patients are required to have two negative pregnancy tests before treatment begins, and once it does, they must use not one but two reliable forms of contraception. Additionally, before beginning treatment, women must receive counseling about the risks, which extend up to four weeks after the final dose. Patients also provide informed written consent to the program, referred to in the United States as “iPledge.”

Yet studies in various countries have shown poor adherence to the pregnancy prevention guidelines, says Dr. Brandace Winquist, co-author and a collaborator with the Canadian Network for Observational Drug Effect Studies. In a podcast, she cites previous research that found a third of all women who became pregnant while using the drug were already pregnant when beginning treatment, while another study found this figure was more likely 60 percent.

The new study, conducted at the request of Health Canada, investigated whether women adhered to the guidelines.

Winquist and her colleagues used administrative data from four provinces: British Columbia, Saskatchewan, Manitoba, and Ontario. In Canada, the average age of isotretinoin users is about 24 years old, with half of all prescriptions written for female patients. Over the 15-year study period from 1996 to 2011, a total of 59,271 female patients received 102,308 courses of isotretinoin. The researchers estimate an annual pregnancy rate during treatment of 16 to 24 per 1,000 users.

Of the total 1,473 pregnancies, almost 20 percent of the women spontaneously aborted, while nearly 71 percent had a medical termination. About 8 percent of the pregnancies (118) resulted in a live birth, where 9 percent, or 11 babies, were born with abnormalities.

Generally, Winquist commented, about 4 percent of all babies in Canada are born with a congenital anomaly. “It is clear from this experience and from studies in Europe that modifying contraceptive behavior in this setting is difficult,” concluded the authors, who added that doctors and patients must constantly be reminded of the risks of isotretinoin.

Effective acne treatments need not result in worse scars than the condition itself.

Source: Henry D, Dormuth C, Winquist B, et al. Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. CMAJ. 2016.

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