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. |