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Contraception Safety Program for Acne Drug Failing in Canada

Accutane raises risk of birth defects, but many women taking it don't follow guidelines to avoid pregnancy, study finds

MONDAY, April 25, 2016 (HealthDay News) -- A Canadian program to prevent pregnancy in women who are taking the acne drug isotretinoin is failing because many women do not follow the program's recommendations, a new study finds.

Isotretinoin increases the risk of birth defects and miscarriages, the researchers explained. First marketed as Accutane, isotretinoin is now sold under various brand names and aimed at patients with severe acne.

The Canadian program recommends informed written consent, two negative pregnancy tests before beginning treatment with isotretinoin, and the use of two reliable birth control methods while taking the drug.

The United States has similar safeguards in place. In 2005, the U.S. Food and Drug Administration approved a program requiring doctors to enroll patients who take isotretinoin in a national registry to guard against serious side effects that had been linked to the drug.

U.S. women must also have a pregnancy test within seven days before filling their prescription and must agree to use two methods of birth control and adhere to pregnancy testing on a monthly basis, according to the FDA.

In the Canadian study, researchers examined the medical records of more than 59,000 women, aged 12 to 48, in four provinces -- British Columbia, Manitoba, Ontario and Saskatchewan -- who took isotretinoin between 1996 and 2011.

During those 15 years, there were 1,473 pregnancies resulting in 118 live births. Of those births, 11 babies (9 percent) had birth defects. The study found that 30 percent to 50 percent of the women taking the drug did not comply with the guidelines to prevent pregnancy.

The study was published April 25 in the Canadian Medical Association Journal.

"Poor adherence with the Canadian pregnancy prevention guidelines means that Canada, inadvertently, is using pregnancy termination rather than pregnancy prevention to manage fetal risk from isotretinoin," study author Dr. David Henry said in a journal news release. He is a senior scientist at the Institute for Clinical Evaluative Sciences and executive co-lead of the Canadian Network for Observational Drug Effect Studies.

"It appears that not all doctors and patients are sticking closely to the guidelines to prevent pregnancy during treatment with isotretinoin," he added.

These and other findings show that it's difficult to get women to follow pregnancy prevention measures while taking isotretinoin, according to study co-author Brandace Winquist, director of decision support for Cypress Health Region in Saskatchewan.

"Nevertheless, medical practitioners and patients must be constantly reminded of the risks of isotretinoin to the fetus and implement effective contraceptive measures," Winquist said in the news release.

More information

The U.S. National Library of Medicine has more on isotretinoin.


SOURCE: Canadian Medical Association Journal, news release, April 25, 2016

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