[콕!Health] "Acne Treatment Main Ingredient 'Isotretinoin' Increases Risk of Fetal Malformations... Pregnant Women Should Avoid Use"

Ilsan Paik Hospital Obstetrics and Gynecology Professor Han Jeong-yeol's Team Meta-Analysis
Women Taking Acne Medication Have Up to 3.76 Times Higher Risk of Birth Defects
80% of Pregnant Women Taking Medication Abort... 65% by Their Own Choice
"Safe to Conceive Only After at Least 4 Weeks of Stopping Medication"

Professor Han Jeong-yeol of the Obstetrics and Gynecology Department at Ilsan Paik Hospital is conducting a consultation with a pregnant woman.

[Asia Economy Reporter Lee Gwan-joo] Pregnant women or women preparing for pregnancy must be very cautious when taking acne medications. This is because the main ingredient of acne medication, 'Isotretinoin,' can cause fetal malformations.

The research team led by Professor Han Jeong-yeol from the Department of Obstetrics and Gynecology at Inje University Ilsan Paik Hospital conducted a meta-analysis by compiling internationally published papers on the risk of malformations in pregnant women who took isotretinoin, and announced the results on the 6th.

The team analyzed 10 papers, including 5 from the United States, 2 from Canada, 1 from Germany, 1 from the Netherlands, and 1 joint study (Israel, Italy, Canada). The study included 2,783 pregnant women exposed to isotretinoin.

The meta-analysis showed that the risk of giving birth to a child with malformations was up to 3.76 times higher in women exposed to isotretinoin compared to the unexposed group. Among the 380 pregnant women who took isotretinoin and gave birth, 15% (59 women) were confirmed to have children with malformations. Major malformations included skull and facial deformities, central nervous system damage, heart defects, polydactyly, facial and neck malformations, and syndactyly of the fingers.

There was a difference in the risk of malformations depending on the year of analysis. Studies before 2006 showed a 3.76-fold increase in malformation risk, whereas studies after 2006 showed a significantly reduced risk of 1.04 times. The research team estimated that compared to the past, acne treatment with isotretinoin has become standardized, showing therapeutic effects even at low doses, resulting in an overall reduction in dosage and duration of use, which in turn reduced the risk of fetal malformations.

In fact, before 2006, the maximum daily dose of isotretinoin was 87.3 mg, but after 2006, it decreased to 43.7 mg. Subsequently, many other studies confirmed efficacy with low doses of 0.25 to 0.5 mg/kg per day.

Prevalence of congenital malformations in women taking isotretinoin.

The problem lies in the abortion rate among women who took isotretinoin. Among pregnant women who took isotretinoin, 80% ended in abortion. Of these, 65% were found to have chosen abortion themselves. A Canadian study showed that among 8,609 women aged 13 to 45 who took isotretinoin between 1984 and 2002, 90 became pregnant, and 76 (84%) chose to terminate their pregnancies. In a U.S. study, 72% of pregnant women who took isotretinoin terminated their pregnancies.

South Korea showed similar figures. According to data from the MotherSafe specialized counseling center, over 1,500 consultations were conducted with pregnant women who took isotretinoin between 2010 and 2021, and more than 50% of them reportedly chose to terminate their pregnancies.

This phenomenon is partly attributed to the misuse of acne medications. Isotretinoin, approved by the Ministry of Food and Drug Safety, is applied to severe acne such as nodular or cystic acne. It is restricted to be prescribed only when other first-line treatments are ineffective. However, it is being misused to treat mild acne or for sebum control, so caution is necessary.

Professor Han Jeong-yeol explained, “Isotretinoin is known to cause malformations by suppressing the activity of neural crest cells and interfering with interactions between cells,” adding, “It has been reported to negatively affect the development of the brain, face, palate, heart, spinal cord, ears, and thymus.” He continued, “Many women who become pregnant while taking isotretinoin have a high risk of malformations and often terminate their pregnancies out of fear and anxiety. These women need to seek help through accurate diagnosis and testing by specialists.”

The U.S. Food and Drug Administration (FDA) recommends waiting at least 4 weeks after stopping isotretinoin before becoming pregnant. Women exposed to isotretinoin during the contraindicated period can contact the non-profit organization MotherSafe specialized counseling center for professional consultation.

Meanwhile, the results of this study were published in the recent issue of the international journal of the Korean Society of Obstetrics and Gynecology, Obstetrics & Gynecology Science.