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Contraception options should be given with oral retinoids to avoid serious harm to unborn babies

20 May 2024
Prescription oral retinoids to treat acne are increasing in popularity. Concerningly, data reveals not enough precautions are being taken to protect women from the risk of serious congenital abnormalities if they fall pregnant while on this medication.

Demands for oral retinoids to treat acne have nearly doubled in the last nine years, but a study has found contraception is being neglected for reproductive aged women taking these medications.

Oral retinoids such as isotretinoin, if taken around the time of pregnancy, are known to cause miscarriage, major congenital abnormalities and issues with child neurodevelopment. These serious issues are not seen in the topical (applied to the skin) forms of retinoids.  

The researchers are concerned about the increased use of retinoids and lack of contraception coverage, with only one in four women taking both.

“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 oral retinoids, and thereby reduce the risk of harm to unborn babies,” says senior author Dr Antonia Shand from the University of Sydney.

“This is certainly a problem. I have seen multiple women who have conceived unintended pregnancies while using oral retinoids, and then women are left needing to manage the consequences,” says lead author and Maternal Fetal Medicine specialist Dr Laura Gerhardy.

The findings, published in the Australasian Journal of Dermatology, examined data from the Pharmaceutical Benefit Scheme in Australia between 2013 to 2021, for a sample of 15 to44-year-old Australian women.

Researchers from University of Sydney and University of New South Wales, analysed rates of oral retinoid prescriptions and how many were provided with contraception.

In nine years, there were 1,545,800 retinoid prescriptions to reproductive-aged women, and 57 percent were oral retinoids in Australia. The remainder were taking topical retinoids.

The rate of oral retinoid dispensing doubled from 1 in 71 women in 2013 to 1 in 35 women in 2021. However, only 25 percent of these oral retinoid prescriptions in 2021 had evidence of contraceptive use at the same time.

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 oral retinoids, and thereby reduce the risk of harm to unborn babies.
Dr Antonia Shand

Leading organisations in dermatology, obstetrics, and pharmaceutical regulatory bodies recommend avoiding pregnancy during use of oral retinoids and for a period following treatment.

But Australia currently does not have a standardised pregnancy prevention programme for women using oral retinoids. By comparison, in the United States, they require that women take two forms of contraception when using oral retinoids.

The researchers are calling for improved education of prescribers, and a clear pathway for reproductive aged women to safely obtain both retinoid and long-acting reversible contraception.

They suggest that education for women is equally important. This includes an effective contraception plan put in place well in advance of an oral retinoid prescription being provided, to prevent any future harms.


Declaration: For more information please refer to the paper. Ethics approval for the study was obtained from the NSW Population and Health Services Research Ethics Committee.  Data access was granted by the Services Australia External Request Evaluation Committee.NN is supported by the Financial Markets Foundation for Children. HZ was supported by a UNSW Scientia Program Award. SAP is a member of the Drug Utilisation Sub Committee of the Pharmaceutical Benefits Advisory Committee, and the views expressed in this paper do not represent those of the committee. The remaining authors have no disclosures to report.

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