Abstract
We described a neonate with severe and multiple abnormalities following use of isotretinoin, in spite of the mother's previous knowledge of drug complications. Initial physical examination after delivery showed congenital absence of both eyes and both auricles as well as anal atresia and a cleft palate. Due to severe respiratory distress and atresia of the anus, the neonate was admitted to a neonatal intensive care unit and underwent reconstructive surgery. The drug should not have been used during pregnancy. Using this drug within pregnancy with awareness of its side effects may have legal consequences.
Introduction
Drugs with a high risk for congenital abnormalities play an important role in forensic medicine. Isotretinoin or 13-cis retinoic acid is a pharmaceutical drug used for treating both benign and malignant disorders. 1 While tretinoin provides benefits for treatment of different skin-related disorders such as lesions caused by photosensitization, nodular or cystic acne, rosacea and hyperpigmentation, there is a potential downside. Serious cardiovascular, cerebrovascular, limb, and sensory organ defects have been described following topical use of tretinoin during the first trimester of pregnancy.2,3 The increased risk of using isotretinoin includes miscarriage, premature birth, fetal defects such as cleft palate, heart anomalies, hydrocephalus, microcephaly, and missing thymus gland. 4 Although several case studies have been reported describing teratogenicity of isotretinoin, given the importance of these lesions in forensic medicine, addressing neonatal anomalies following maternal use of this drug seems to be appropriate.
Case presentation
A 24-year-old woman was referred to an obstetrician due to her delayed menstrual cycle. In the medical history, she reported using isotretinoin from five months previously because of severe acne. Beta pregnancy test and ultrasonography were requested resulting in a diagnosis of pregnancy with a gestational age (GA) of 16 weeks. It was her first pregnancy, and she had no serious medical conditions. The drug was discontinued immediately and pregnancy continued until term under the supervision of the gynecologist. The patient delivered at 39 weeks by normal vaginal delivery giving GA term female infant with a weight of 2750 g. Initial physical examination showed congenital absence of both eyes and both auricles as well as anal atresia and cleft palate. Due to severe respiratory distress and atresia of anus, the neonate was admitted to neonatal intensive care unit and underwent reconstructive surgery.
Conclusion
Neonatal anomalies can lead to serious disabilities throughout a person's life. Some of these anomalies result from parental negligence, especially mothers if they intentionally or unintentionally use some teratogenetic drugs before or even during pregnancy. Thus, it is clear that women need to consult with an obstetrician for preconception advice on the use of drugs. 5 If a disease is non-life threatening such drugs should not be used until after the birth. In other words, continuing the use of teratogenetic drugs within pregnancy with awareness of their side effects may have legal consequences. In these situations, the role of legal medicine is highlighted. In our report and based on interviews with the parents, this mother continued the drug use whilst knowing its serious side effects. Further, continued treatment of acne with isotretinoin was not essential for her. Legal medicine authorities should be made aware of this problem. Isotretinoin or Accutane was initially approved by the U.S. Food and Drug Administration in 1982 for treating severe acne leading to cure in more than 80% of patients. 6 However, numerous reports of its related side effects has limited its use and especially among pregnant women. Due to the risk of serious birth defects, women of child-bearing age must commit to programmes aimed at preventing pregnancies during treatment. A year after introducing isotretinoin as a potential effective medication for skin disorders, the first reports of fetal defects due to its consumption were noted. Since then, the FDA recommended that its use be discontinued until delivery and during breastfeeding. Some authors claim there are 42% of neonatal defects in mothers who use the drug during pregnancy. 7 In some studies, the rate of elective abortions for patients who became pregnant during accutane use was found to be 84%. 8 Thus, discontinuation of the drug, even before starting a pregnancy, is strongly recommended. In addition, replacing it with a safer drug in cases of necessity is vital.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.