Women Ignore Contraception Rules While on Accutane

Although popular acne treatment isotretinoin (Accutane) has been known to cause birth defects, many women still fail to follow simple contraception rules.

Although popular acne treatment isotretinoin (Accutane) has been known to cause birth defects, many women still fail to follow simple contraception rules.

Belonging to the class of drugs known as retinoids, isotretinoin is prescribed for patients suffering from severe recalcitrant nodular acne who haven’t responded to other treatments.

Despite Accutane’s solid high rates of efficacy, the acne drug was considered a danger to female patients who became pregnant while using it.

Pregnant women taking Accutane often face higher rates of spontaneous abortion and developing fetuses could be born with severe birth defects like craniofacial and heart defects.

To combat these precarious outcomes, experts have published pregnancy prevention guidelines for the women who are prescribed the drug.

In the US, the FDA launched the iPledge program, which works to reduce fetal exposure to Accutane. Only prescribers and pharmacists registered to the program are allowed to prescribe and dispense the drug. Furthermore, any patient who wants to use Accutane must be registered to iPledge and complete an informed consent form.

Women of reproductive age are required to have two negative pregnancy tests before they can be prescribed Accutane, and must undertake a pregnancy test each month of drug use and use two forms of contraception — all recorded monthly by their healthcare provider.

Although Canada does not have a perfectly equivalent program to iPledge, it does have one that “requires informed written consent, two pregnancy tests with negative results before starting isotretinoin, and two reliable forms of contraception during treatment.”

According to a study lead by David Henry, MD, senior scientist at the Institute for Clinical Evaluative Sciences (ICES) Canada, showed that many women and their health care providers are not adhering to the rules.

Henry and colleagues analyzed the health records for 59,271 women from British Columbia, Saskatchewan, Manitoba, and Ontario between 12-48 years who were taking Accutane between 1996 and 2011.

Results from the 15-year study period identified 1,473 pregnancies, of which 1,331 terminated spontaneously or were terminated by medical intervention. Among the 118 live births, 11 cases had congenital malformation.

Most notably, researchers found that between 30-50% of women prescribed Accutane did not follow existing guidelines.

“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,” said Henry.

The authors did acknowledge only a modest impact the iPledge program appeared to have on the increased uptake of oral contraceptives and lower numbers of fatal pregnancies.

The authors concluded, “It is clear from this experience and from studies in Europe that modifying contraceptive behavior in this setting is difficult. Nevertheless, medical practitioners and patients must be constantly reminded of the risks of isotretinoin to the fetus and must adhere to the policy that mandates effective contraceptive measures.”