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article imageCanadian women failing to take precautions while using Accutane

By Karen Graham     Apr 26, 2016 in Health
Canada's pregnancy prevention program for women taking the powerful acne drug isotretinoin (Accutane) is failing, according to a new study.
Isotretinoin is sold under the brand name Accutane and in the generic form. It is used to treat severe cystic acne and acne that has not responded to other treatments.
The drug has been available in Canada since 1983, reports CTV News. It is a vitamin A derivative called a retinoid that reduces the production of an oily skin substance called sebum. The drug has proven to be highly effective but is also well known for causing birth defects and miscarriages.
Isotretinoin is classified as a teratogen, because of its toxic effects on the embryo or fetus. For that reason, there are restrictions on its use in countries around the world, including Canada, the UK, and U.S., among others.
Dr. David Henry, a senior scientist at the Institute for Clinical Evaluative Sciences (ICES) and executive co-lead of the Canadian Network for Observational Drug Effect Studies (CNODES) is the lead author of a new study published in the Canadian Medical Association Journal (CMAJ) that took a closer look at compliance with users of Accutane.
In Canada's Pregnancy Prevention Program, women of child-bearing age 12 to 48 years-old are required to give written informed consent that they understand the risks, have two negative pregnancy tests before beginning treatment and agree to use two forms of birth control while on the medication.
But after analyzing the records of 59,271 women taking isotretinoin in four Canadian provinces, British Columbia, Manitoba, Ontario, and Saskatchewan, between 1996 and 2011, researchers found there were 1,473 pregnancies, of which only 118 (8.0 percent) resulted in live births; of those, 11 (9.0 percent) were identified as having congenital abnormalities.
According to U.S. News and World Report, the study found that despite the high risks involved in taking the acne treatment, fully 30 to 50 percent of the women taking the drug failed to comply with the pregnancy prevention guidelines. In a press release, Dr. Henry was quoted as saying, "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."
Talking about the failed effectiveness of the pregnancy prevention program, Dr. Henry says the rate of compliance hasn't improved in the last 15 years of the drug being available, and “It is the responsibility of doctors and pharmacists to ensure that these drugs are prescribed and dispensed safely and it’s the responsibility of patients to use them properly."
A spokesperson for Health Canada said the agency is reviewing the results of the study “and will take appropriate action as needed upon completion of its review.”
The study, "Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy" was published April 25, 2016, in the Canadian Medical Association Journal.
More about Accutane, avoiding pregnancy, Birth defects, isotretinoin, CMAJ
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