Isotretinoin Exposure during Pregnancy
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Drug Saf 2010; 33 (8): 659-665 0114-5916/10/0008-0659/$49.95/0
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Isotretinoin Exposure during Pregnancy Assessment of Spontaneous Reports in France Elisabeth Autret-Leca,1,2 Carmen Kreft-Jais,3 Elisabeth Elefant,4 Haware´ Cissoko,1 Franc¸ois Darrouzain,1 Lamiae Grimaldi-Bensouda,1,2 Sarah Attia3 and Annie Pierre Jonville-Be´ra1 1 CHRU de Tours, Service de Pharmacologie Clinique, Centre Re´gional de Pharmacovigilance et d’Information sur le Me´dicament, Tours, France 2 Universite´ Franc¸ois Rabelais de Tours, Service de Pharmacologie Clinique, Centre Re´gional de Pharmacovigilance et d’Information sur le Me´dicament, Tours, France 3 Agence Franc¸aise de Se´curite´ Sanitaire des Produits de Sante´, St Denis, France 4 Centre de Re´fe´rence sur les Agents Te´ratoge`nes, Paris, France
Abstract
Background: In three previous studies, we have shown that pregnant women were still being exposed to isotretinoin and that compliance with recommendations was incomplete. The relaxation of these recommendations (summary of product characteristics 2004), combined with the release of generic brands, encouraged us to carry out a fourth study. Objective: To assess isotretinoin exposure during pregnancy following the application of less stringent recommendations and the marketing of generic isotretinoin brands. Methods: All cases of isotretinoin exposure during pregnancy, between 1 January 2003 and 31 December 2006, spontaneously reported to pharmacovigilance centres, the Teratogenic Agent Information Centre, and pharmaceutical companies in France were assessed. Cases were classified for analysis into the following groups: ‘conception
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