Oral retinoids are a type of medicine used to . They’re sold under the brand name Roaccutane, among others.
Authors
Antonia Shand
Research Fellow, Obstetrician, University of Sydney
Natasha Nassar
Professor of Paediatric and Perinatal Epidemiology and Chair in Translational Childhood Medicine, University of Sydney
While oral retinoids are very effective, they can have harmful effects if taken during pregnancy. These medicines can cause miscarriages and (harm to unborn babies) including in the brain, heart and face. At least exposed to oral retinoids in pregnancy have severe congenital abnormalities.
Neurodevelopmental problems (in learning, reading, social skills, memory and attention) are also common.
Because of these risks, the oral retinoids should not be prescribed a month before or during pregnancy under any circumstances. Dermatologists are instructed to make sure a woman isn’t pregnant before starting this treatment, and discuss the risks with women of childbearing age.
But despite this, and warnings on the , pregnancies exposed to oral retinoids continue to be reported and .
In published this month, we wanted to find out what proportion of Australian women of reproductive age were taking oral retinoids, and how many of these women were using contraception.
Our results suggest a high proportion of women are not using effective contraception while on these drugs, indicating Australia needs a strategy to reduce the risk oral retinoids pose to unborn babies.
Contraception options
Using birth control to avoid pregnancy during oral retinoid treatment is essential for women who are sexually active. Some contraception methods, however, are more reliable than others.
Long-acting-reversible contraceptives include intrauterine devices (IUDs) inserted into the womb (such as Mirena, Kyleena, or copper devices) and implants under the skin (such as Implanon). These “set and forget” methods are .
The effectiveness of among “perfect” users (following the directions, with no missed or late pills) is similarly more than 99%. But in typical users, this can fall as low as 91%.
Condoms, when used as the sole method of contraception, have . Their effectiveness can be as low as 82% in typical users.
Oral retinoid use over time
For , we analysed medicine dispensing data among women aged 15-44 from Australia’s Pharmaceutical Benefit Scheme (PBS) between 2013 and 2021.
We found the dispensing rate for oral retinoids doubled from one in every 71 women in 2013, to one in every 36 in 2021. The increase occurred across all ages but was most notable in young women.
Most women were not dispensed contraception at the same time they were using the oral retinoids. To be sure we weren’t missing any contraception that was supplied before the oral retinoids, we looked back in the data. For example, for an IUD that lasts five years, we looked back five years before the oral retinoid prescription.
Our analysis showed only one in four women provided oral retinoids were dispensed contraception simultaneously. This was even lower for 15- to 19-year-olds, where only about one in eight women who filled a prescription for oral retinoids were dispensed contraception.
A recent found 43% of Australian year 10 and 69% of year 12 students are sexually active, so we can’t assume this younger age group largely had no need for contraception.
One limitation of our study is that it may underestimate contraception coverage, because not all contraceptive options are listed on the PBS. Those options not listed include male and female sterilisation, contraceptive rings, condoms, copper IUDs, and certain oral contraceptive pills.
But even if we presume some of the women in our study were using forms of contraception not listed on the PBS, we’re still left with a significant portion without evidence of contraception.
What are the solutions?
Other countries such as the and countries in have pregnancy prevention programs for women taking oral retinoids. These programs include contraception requirements, risk acknowledgement forms and regular pregnancy tests. Despite these programs, unintended pregnancies among women using oral retinoids still occur in these countries.
But Australia has no official strategy for preventing pregnancies exposed to oral retinoids. Currently oral retinoids are prescribed by dermatologists, and most contraception is prescribed by GPs. Women therefore need to see two different doctors, which adds costs and burden.
Rather than a single fix, there are likely to be multiple solutions to this problem. Some dermatologists may not feel confident discussing sex or contraception with patients, so educating dermatologists about contraception is important. Education for women is equally important.
A clinical pathway is needed for reproductive-aged women to obtain both oral retinoids and effective contraception. Options may include GPs prescribing both medications, or dermatologists only prescribing oral retinoids when there’s a contraception plan already in place.
Some women may initially not be sexually active, but change their sexual behaviour while taking oral retinoids, so constant reminders and education are likely to be required.
Further, needs to be improved in Australia. Teenagers and in particular face barriers to accessing contraception, including costs, stigma and lack of knowledge.
Many doctors and women are doing the right thing. But every woman should have an effective contraception plan in place well before starting oral retinoids. Only if this happens can we reduce unintended pregnancies among women taking these medicines, and thereby reduce the risk of harm to unborn babies.
Dr Laura Gerhardy from NSW Health contributed to this article.
Antonia Shand receives funding from National Blood Authority. She is employed by New South Wales Health. She is a Member of an Expert Group revising Therapeutic Guidelines, Antibiotic 17: Surgical prophylaxis, trauma and perinatal infections. She is a fellow of RANZCOG.
Natasha Nassar receives funding from NHMRC, MRFF, Financial Markets Foundation for Children, NSW Health, Cancer Australia, Luminesce Alliance.
