Does Acne Medication Cause Birth Defects, Miscarriages or Spontaneous Abortion?

Canada’s program that has a goal to prevent pregnancy in women who use a powerful acne medication isotretinoin, has not been effective, according to a new study. Isotretinoin is used to treat severe acne and it can be extremely harmful to a developing fetus. The drug can cause craniofacial, cardiac and central nervous system defects, as well as increase a woman’s likelihood of miscarriage or needing a medical termination.

The Study

Of the women taking isotretinoin, 30-50 percent do not comply with the program’s requirements, which, given the danger the drug can cause to a developing fetus, represents poor performance of the pregnancy prevention program.

Dr. David Henry, senior scientist at the Institute for Clinical Evaluation Sciences stated, “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. It appears that not all doctors and patients are sticking closely to the guidelines to prevent pregnancy during treatment with isotretinoin.”

The drug which is commonly marketed as Accutane when it was first released, is used to treat severe acne and was first approved for Canadian use in 1983. The average age of isotretinoin users in Canada is estimated to be 24 years old and half of all prescriptions are written for women.

The Canadian program recommends informed written consent, two negative pregnancy tests before starting the treatment and the use of two reliable forms of birth control during treatment.
There have been numerous studies done in Canada and internationally, the results have indicated poor adherence to pregnancy prevention guidelines among women who take Accutane

Researchers reviewed anonymized patient records for 59,271 women taking the drug, they were between the ages of 12 to 48 years old, in four Canadian provinces; Ontario, British Columbia, Manitoba, and Saskatchewan. The information was for the years 1996 through 2011. Over the 15 year period, there were 1473 pregnancies, 118 of which were live births, 11 were identified as having congenital abnormalities.
Pregnancy rates during acne treatment with isotretinoin ranged from 4-6 per 1,000 users. The at-risk period for exposure is towards the end of treatment and overall pregnancy rates including this period of time were much higher.

In spite of the recommendations for women to be using two types of reliable birth control while taking isotretinoin, researchers discovered that only one-quarter to one-third of women filled birth control prescriptions, nearly identical to rates within the previous year.

However, the researchers also noted that they were not able to track the use of birth control pills obtained without plan coverage or directly from a supply from a physician, or the use of intrauterine devices or barrier methods.


Dr. Brandace Winquist, co-author of the study stated, “It is clear from this experience and from studies in Europe that modifying contraceptive behavior in this setting is difficult.”

However, medical practitioners and patients must constantly be reminded of the serious risks faced by an unborn child when the mother takes isotretinoin for severe acne.


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