Mon May 20

Oral retinoids can harm unborn babies. But many women taking them for acne may not be using contraception

Written by: Antonia Shand, Research Fellow, Obstetrician, University of Sydney

Oral retinoids are a type of medicine used to treat severe acne ^[1]. They’re sold under the brand name Roaccutane, among others.

While oral retinoids are very effective, they can have harmful effects if taken during pregnancy. These medicines can cause miscarriages and major congenital abnormalities ^[2] (harm to unborn babies) including in the brain, heart and face. At least 30% of children ^[3] 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 Australasian College of Dermatologists advises ^[4] 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 medicines’ packaging ^[5], pregnancies exposed to oral retinoids continue to be reported in Australia ^[6] and around the world ^[7].

In a study ^[8] 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 more than 99% effective ^[9].

A newborn baby in a clear crib in hospital.

Oral retinoids taken during pregnancy can cause complications in babies. Gorodenkoff/Shutterstock ^[10]

The effectiveness of oral contraceptive pills ^[11] 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 higher failure rates ^[12]. Their effectiveness can be as low as 82% in typical users.

Oral retinoid use over time

For our study ^[13], 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 study ^[14] 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.

A graph showing oral retinoid dispensing by age, with and without contraception.

This graph shows oral retinoid dispensing by age, with and without contraception. Australasian Journal of Dermatology, Author provided (no reuse)

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 United States ^[15] and countries in Europe ^[16] 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.

Hands holding a contraceptive pill packet.

Preventing pregnancy during oral retinoid treatment is essential. Krakenimages.com/Shutterstock ^[17]

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, contraception access ^[18] needs to be improved in Australia. Teenagers and young women ^[19] 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.