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Isotretinoin – A magical medication or dangerous drug?

It was a beautiful morning in December 2022, and I was sleeping when a phone call woke me up. My friend, a 23-year-old lady who had just gotten married a couple of months ago, was crying on the phone. She admitted that she had taken over-the-counter isotretinoin orally for acne treatment in November while having just discovered that she was five weeks pregnant. This means that she took teratogenic drugs during the first trimester of pregnancy, which poses high risks of congenital defects to her newborn.

The risk of teratogenicity induced by isotretinoin is estimated to be 20-35% for infants that are exposed to the drug in utero and includes cardiovascular and neurological malformations, craniofacial defects, or thymic disorders [1].

At this moment, the young mother-to-be must decide to whether keep the baby with serious concerns about her newborn’s health or terminate the pregnancy without ever knowing her baby’s status. Although modern technologies might provide some aid in the prediction of fetus malformations at the early pregnant stage, it remains uncertain if the child will grow without neurocognitive impairments, even in the absence of any physical defects established to be 30-60% in the children exposed to isotretinoin during the prenatal period. Therefore, this surely is one of the most difficult decisions that this mother, and any other mother in the world, has ever had to make [1].

Why did this case study happen?

Isotretinoin is an oral derivative of vitamin A which has been used since 1982 as an effective treatment for a wide range of dermatologic pathologies such as severe acne as well as scarring alopecia, rosacea, ichthyosis, or non-melanoma skin cancer prophylaxis. The recommended dose is 0.5-1 mg/kg/day for 4-6 months in sebaceous gland disorders. It is the medication that affects all 4 pathogenic factors of acne, thus this drug is the first line of treatment for severe acne unresponsive to other medications [1, 2].

However, as a member of the retinoid family, it also has a lot of side effects, including reproductive, neurological, musculoskeletal, ocular, hepatic, and cutaneous [3].

Myalgias and mucocutaneous events are the most common isotretinoin side effects and “xerosis” might be a simple word to describe the patient taking the treatment. Cheilitis is universal in patients on the treatment, so its absence can be interpreted as a treatment failure or an indication of non-compliance. Besides the common side effects which the cessation of treatment leads to spontaneous resolve, depression, suicide, and teratogenicity are of great concern. There is no safe dose at any time during pregnancy. Therefore, it is very necessary to have at least 2 negative pregnancy results before treatment and acceptable forms of contraception during treatment duration and 1 month after the therapy. Effective contraception should consist of both a primary (tubal ligation, partner's vasectomy, topical, injectable, implantable, or insertable hormonal birth control products, or estrogen-containing contraceptive pills) and a secondary method of birth control (condom, cervical cap, each to be used with spermicide). Based on pharmacokinetic studies of isotretinoin, a washout period of 35 days post isotretinoin therapy would be adequate in routine clinical practice [1, 2, 3].

In conclusion, isotretinoin is a highly effective medication for severe acne as well as certain skin disorders, but at the cost of several side effects. Therefore, isotretinoin should only be prescribed by or under the supervision of qualified physicians with expertise in the use of systemic retinoids and a full understanding of the risks of isotretinoin therapy and the entailing monitoring requirements.


[1] Draghici, C. C., Miulescu, R. G., Petca, R. C., Petca, A., Dumitrașcu, M. C., & Șandru, F. (2021). Teratogenic effect of isotretinoin in both fertile females and males (Review). Experimental and therapeutic medicine, 21(5), 534.

[2] Jajoria, H., & Mysore, V. (2020). Washout Period for Pregnancy Post Isotretinoin Therapy. Indian dermatology online journal, 11(2), 239–242.

[3] Brelsford, M., & Beute, T. C. (2008). Preventing and managing the side effects of isotretinoin. Seminars in cutaneous medicine and surgery, 27(3), 197–206.

*Photo sources: Pexels and personal photos

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