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. 2018 Aug 29;8(3):377–382. doi: 10.15171/apb.2018.044

Table 1. The summary of studies about use of isotretinoin during pregnancy .

References Study design Country Total number of patients Results
Entezari-Maleki T, et al.26 2012 Prospective, drug utilization evaluation Iran 274 6.8% of patients used two methods of contraceptive
51.3% received isotretinoin under the usual recommended daily doses
Teichert M, et al.35 2010 Retrospective study Dutch 4881 Concomitant use of oral hormonal or intrauterine contraceptives and isotretinoin was 59.3%.
Pinheiro SP, et al.43 2013 Prospective comparative study USA 113 578 Temporary increase in concomitant use of isotretinoin and contraceptives was observed immediately after iPlEDGE implementation
Shin J, et al.44‏ 2011 Retrospective comparative study USA 9912 The risk of fetal exposure after iPLEDGE implementation reduced significantly in comparison with the SMART program
Berard A, et al.45 2007 Prospective population-based study ‏‍Canada 8609 A total of 9 live births occurred.
Crijns HJ, et al.46 2011 Systematic review of 17 studies‏ Europe 141 0·2–1·0 per 1000 women of reproduction age receiving isotretinoin became pregnant whereas 65% – 87% of these pregnancies were terminated
Schaefer C, et al.47 2010 Observational prospective study Germany 108 A total 18 live births occurred‏ 
Autret-Leca E. et al.48 2010 Prospective population-based study France 147 A total of 147 cases of isotretinoin exposure were reported
Zomerdijk IM, et al.49 2014 Retrospective population-based study Netherlands 203962 Among those potentially exposed to isotretinoin, three intrauterine deaths and two live-born infants with major congenital anomalies occurred.
Crijns I, et al.50 2013 Prospective descriptive study Netherlands 556‏  In addition to poor compliance of pharmacists, that 25% of dermatologists were compliant with the PPP
Crijns HJ, et al.51 2012 Prospective drug utilization study Netherlands 651 53% of the 651 patients on isotretinoin therapy were prescribed to use contraceptive before, during, and after discontinuation of isotretinoin in accordance to the PPP.
Crijns I, et al.52 2012 Prospective questionnaire- based study Europe, Norway and Iceland 143 Exposing to isotretinoin in spite of the PPP implementation.