Do not use Accutane when trying to get pregnant and during pregnancy!
According to the Canadian Medical Association in response to a recent study that said Canadian women are not heeding pregnancy warnings about the use of isotretinoin, a potent but effective drug that treats severe acne. The drug, originally marketed under the brand name Accutane, comes with a very high risk of severe birth defects, miscarriage, and elective pregnancy termination. The study found many women are getting pregnant while taking isotretinoin in spite of the warnings of tragic results that could occur.
Isotretinoin (Accutane)
Isotretinoin, a drug that molecularly resembles retinoic acid (a derivative of vitamin A), successfully treats severe cystic acne and other forms of acne that have proven resistant to treatment. It is also used to treat some forms of cancer and certain rare skin disorders.
How the drug works, exactly, is not fully understood but it has been shown to induce apoptosis, a controlled and natural form of cell death required for continued health throughout a lifetime. In the womb, retinoic acid is part of the control process for normal embryonic development.
The drug is a powerful teratogen (causes fetal abnormalities and birth defects) likely to cause pregnancy and fetal complications when taken in the weeks before and during pregnancy. It remains harmful to the child during breastfeeding. A high rate of voluntary abortions is linked to the drug, most of which follow fetal tests that confirm abnormalities.
Birth defects associated with isotretinoin include deformities of the face and head, brain and spinal cord, and the heart. Hearing and visual impairments are more likely in babies prenatally exposed to isotretinoin, as are missing or malformed outer ears and mental retardation.
Safeguards Against Birth Defects
After high rates of miscarriage and birth defects were linked to isotretinoin in the US, the iPLEDGE program was created by the US Food and Drug Administration. The program constitutes a rigorous pledge between every isotretinoin patient, his or her physician, and pharmacy to work together to prevent pregnancy while isotretinoin is being used. As of March 2006, some safeguards against birth defects built into the iPLEDGE program include:
Any physician prescribing the drug must be an active registered member of iPLEDGE.
Pharmacies must be registered to fill prescriptions.
Prescriptions can only be filled for registered individuals, male and female alike.
Only 30-day prescriptions are allowed.
Only the patient whose name is on the prescription can pick up the prescription.
No refills are permitted within the 30-day prescription period, even if the medication gets lost, damaged, or destroyed.
Before getting a prescription, a woman of childbearing age must:
Sign an informed consent agreement documenting her understanding of the dangers involved in taking this drug while pregnant.
Take two pregnancy tests with negative results.
Pledge to use two forms of birth control (other than condoms) at all times or completely abstain from sex while on the drug.
Pledge to wait at least one month after isotretinoin treatment ends before trying to conceive.
The iPLEDGE program has generated a drop in the number of miscarriages, abortions, birth defects, and other maternal-fetal complications associated with the drug.
Isotretinoin in Canada
Canada does not have a policy as stringent as that of the US but relies instead on physician consultations that include the pregnancy-related dangers of using it. Studies in Canada and other nations, including the US, indicate poor compliance with the recommended protective measures.
Canadian researchers analyzed medical records of 59,271 women, 12 to 48 years old, who took isotretinoin between 1996 and 2011 in four provinces – British Columbia, Manitoba, Ontario, and Saskatchewan. In spite of warnings to not get pregnant, there were 1,473 pregnancies that produced only 118 live births (8%).
A look at birth control prescriptions written during the study period indicated fewer than one-third of the women on isotretinoin filled prescriptions for contraceptives. It is likely more women were actually using prescription contraceptives but they were not listed in the national prescription registry. Some of them probably got prescription contraceptives as samples from their doctors, at free clinics, paid out of pocket without reimbursement from the national health plan, or used intrauterine devices (IUDs) or barrier methods such as condoms instead.
Canada’s problem may not be limited to just women not heeding warnings. "It appears that not all doctors and patients are sticking closely to the guidelines to prevent pregnancy during treatment with isotretinoin," according to Dr. David Henry, a senior scientist for the Institute for Clinical Evaluation Sciences and executive co-lead of the Canadian Network for Observational Drug Effect Studies. Henry was the lead author for the study.
Accutane by Other Names
Isotretinoin was developed by the Hoffmann-La Roche pharmaceutical company based in Switzerland and originally sold under the registered trademark name Accutane. It was sold under other brand names in other nations.
Personal injury lawsuits filed by women experiencing pregnancy loss or giving birth to babies with birth defects after taking Accutane were so common in the US that Hoffmann-La Roche stopped selling Accutane in the US in 2009. Isotretinoin is still available here, however, as a generic drug and by other names used by other pharmaceutical companies: Absorica, Amnesteem, Claravis, Epuris, Isotroin, Myorisan, and Sotret.
Sources:
Hemry, David, et al. "Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy." CMAJ / Canadian Medical Association (Joule Inc.) (2016). Web. 30 Apr. 2016.
Andresen, Margot. "Accutane registry compulsory in US, but not Canada." PMC. CMAJ / Canadian Medical Association, 6 June 2006. US National Library of Medicine / National Institutes of Health. Web. 30 Apr. 2016.
"Isotretinoin." MedlinePlus. US National Library of Medicine, 15 Feb. 2013. Web. 30 Apr. 2016.