Selcuk Ozyurt1, Asli Feride Kaptanoglu2. 1. Clinic of Dermatology, İzmir Atatürk Training and Research Hospital, İzmir, Turkey. 2. Department of Dermatology, Near East University Faculty of Medicine, Mersin, Turkey.
Abstract
OBJECTIVE: Isotretinoin is known to be the most effective treatment of severe and persistent acne. However, one of the most important adverse effects of this drug is known to be teratogenicity. In this regard, tests are administered before initiating the treatment, to assure that an unknown pregnancy is not present and accordingly, patients are advised to take contraceptive precautions during their systemic isotretinoin treatments. On the contrary, many cases of unwanted pregnancies and relevant abortuses have been reported all over the world. In the Turkish literature, only a few reports have been identified about foetal exposure to isotretinoin. MATERIALS AND METHODS: In this respect, a study was carried out on fifty-seven female patients, aiming to fulfil the gap of information mentioned above. Female patients, with ages ranging between 14 and 35 years, were recruited to the study and they were administered isotretinoin treatments (cumulative dose of 120 mg/kg) for an average period of 6 months. The patients were followed up during and after the treatment for a total period of 18 months. RESULTS: As a result, it has been observed that none of the patients got pregnant during the treatment period and relevantly, no abortuses or foetal abnormalities were recorded. Moreover, none of the patients got pregnant 12 months after the termination of the treatment. Additionally, the socio-demographic analysis of the patients indicates that most of the patients were single and 81% of the patients were sexually inactive. CONCLUSION: Our findings suggest that the low reportage of teratogenicity due to isotretinoin usage in Turkey could be due to several reasons, such as the sociocultural profile of the female patients undertaking the isotretinoin treatment, and strict adherence to contraceptive methods, and/or underreporting of teratogenic incidents due to lack of studies held in cooperation with obstetricians.
OBJECTIVE:Isotretinoin is known to be the most effective treatment of severe and persistent acne. However, one of the most important adverse effects of this drug is known to be teratogenicity. In this regard, tests are administered before initiating the treatment, to assure that an unknown pregnancy is not present and accordingly, patients are advised to take contraceptive precautions during their systemic isotretinoin treatments. On the contrary, many cases of unwanted pregnancies and relevant abortuses have been reported all over the world. In the Turkish literature, only a few reports have been identified about foetal exposure to isotretinoin. MATERIALS AND METHODS: In this respect, a study was carried out on fifty-seven female patients, aiming to fulfil the gap of information mentioned above. Female patients, with ages ranging between 14 and 35 years, were recruited to the study and they were administered isotretinoin treatments (cumulative dose of 120 mg/kg) for an average period of 6 months. The patients were followed up during and after the treatment for a total period of 18 months. RESULTS: As a result, it has been observed that none of the patients got pregnant during the treatment period and relevantly, no abortuses or foetal abnormalities were recorded. Moreover, none of the patients got pregnant 12 months after the termination of the treatment. Additionally, the socio-demographic analysis of the patients indicates that most of the patients were single and 81% of the patients were sexually inactive. CONCLUSION: Our findings suggest that the low reportage of teratogenicity due to isotretinoin usage in Turkey could be due to several reasons, such as the sociocultural profile of the female patients undertaking the isotretinoin treatment, and strict adherence to contraceptive methods, and/or underreporting of teratogenic incidents due to lack of studies held in cooperation with obstetricians.
Authors: Ineke Crijns; Sabine Straus; Michiel Luteijn; Christine Gispen-de Wied; June Raine; Lolkje de Jong-van den Berg Journal: Drug Saf Date: 2012-01-01 Impact factor: 5.606
Authors: Janet Shin; T Craig Cheetham; Linda Wong; Fang Niu; Elizabeth Kass; Monica A Yoshinaga; Mike Sorel; Jeffrey S McCombs; Stephen Sidney Journal: J Am Acad Dermatol Date: 2011-05-11 Impact factor: 11.527
Authors: E J Lammer; D T Chen; R M Hoar; N D Agnish; P J Benke; J T Braun; C J Curry; P M Fernhoff; A W Grix; I T Lott Journal: N Engl J Med Date: 1985-10-03 Impact factor: 91.245