Canadian women aren’t using a popular acne medication properly commonly known as Accutane and ignoring the guidelines is leading to pregnancy complications, miscarriages and even birth defects, a new study is warning.
If women want to use isotretinoin, sold as Accutane, they need to follow strict guidelines to avoid pregnancy. To get a prescription, they need two negative pregnancy tests and to stick to two birth control methods during treatment. Turns out, up to 50 per cent of women aren’t adhering to these regulations.
Dr. David Henry, the study’s lead researcher, says the findings are meant to remind doctors prescribing the drug, pharmacists dispensing it, and patients using it, that they all have a role to play in explaining and following regulations.
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“We’re not discovering something that wasn’t known before, we’re underlying something to get a message across. It’s about the three parties coming together to use this drug safely,” Henry told Global News.
“We can’t regulate this problem, it requires distinct groups to interact properly,” he explained.
Henry is a senior scientist at the Institute for Clinical Evaluative Sciences (ICES) and co-lead of the Canadian Network for Observational Drug Effect Studies (CNODES).
Health Canada commissioned the study, he said. The federal agency wanted to know if Canadian women were adhering to the pregnancy prevention guidelines tied to the drug.
Isotretinoin — commonly known as Accutane — is used to treat severe acne and scarring. It’s been approved since 1983.
For decades, the medical community knew that the drug can cause harm to a fetus, through defects in the development of the head and brain. Women who get pregnant on the drug ultimately end up getting an abortion or they deal with higher rates of miscarriage. That’s why women must use birth control and provide negative pregnancy tests to stay on the treatment.
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For his research, Henry looked at patient records for more than 59,200 women taking isotretinoin. They were between 12 and 48 years old and from four Canadian provinces — British Columbia, Saskatchewan, Manitoba and Ontario. The study spanned 15 years, from 1996 to 2011. The average age of the women was 24.
During the study, there were 1,473 pregnancies even though women were supposed to be on two forms of birth control.
About eight per cent — 118 — pregnancies were carried to full term. Nine per cent of the babies were born with defects.
These weren’t mild issues either. The drug affects cell turnover during a vulnerable period in fetal development. Babies end up with organ development issues, head, face and central nervous system disfiguring, and abnormalities that require extensive surgery.
Turns out, only one quarter of the women were filling birth control prescriptions while taking the acne medication. But keep in mind, women could be obtaining birth control through other means or they could have been using intrauterine devices, for example.
Henry is worried that the drug could be purchased online or the filled prescription could be shared with others.
Policing the guidelines is tricky — he said in some U.S. states, the doctor, pharmacist and patient have to sign online to make sure they’re holding up their end of the bargain while dealing with isotretinoin.
For now, Henry is putting the onus on doctors and pharmacists to inform and remind patients often.
Hoffmann-La Roche Limited (Roche Canada), the makers of Accutane, say that Health Canada’s pregnancy prevention guidelines are fully outlined in the drug product’s monograph.
“Patient safety is our top priority…and it is important that all Accutane patients and their prescribing physicians follow the terms noted in the Canadian Product Monograph to guide the safe and effective use of this medicine,” a spokeswoman told Global News in an email.
For its part, Health Canada says reviewing the results of the study and “will take appropriate action as needed upon completion of its review.”
“The study found that female patients with acne who are prescribed isotretinoin are becoming pregnant despite well-known guidelines for prescribers and patients designed to prevent pregnancy….Pregnancy rates while on this product in other international jurisdictions are similar to those reported in Canada,” a spokesman said in an email to Global News.
The full findings were published Monday in the Canadian Medical Association Journal. Read the full study.