OBJECTIVE: To review medicines pregnancy category and establish the degree of conformity between the two systems more used: FDA (Food and Drug Administration) and ACPM (advisory Committee on Prescription Medicines). METHODS: drugs used in most frequent pathologies during pregnancy have been selected and found its pregnancy category according to FDA and ACPM. The degree of conformity has been established between both categorisation systems. RESULTS: a total of 270 medicines were reviewed. 260 drugs had pregnancy category by FDA and 245 by ACPM system. 232 drugs had pregnancy category defined by both classifications (FDA and ACPM). We found 70,2% of them in the same pregnancy category. CONCLUSIONS: The discrepancies found in both pregnancy categorisation systems can be confused in order to prescribe and know its safety statement of medicines during pregnancy which can limits its utility. It would be desirable more studies after medicines registered to get more information which could help to use safety drugs during pregnancy and minimize discrepancies between both pregnancy categorisation systems. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
OBJECTIVE: To review medicines pregnancy category and establish the degree of conformity between the two systems more used: FDA (Food and Drug Administration) and ACPM (advisory Committee on Prescription Medicines). METHODS: drugs used in most frequent pathologies during pregnancy have been selected and found its pregnancy category according to FDA and ACPM. The degree of conformity has been established between both categorisation systems. RESULTS: a total of 270 medicines were reviewed. 260 drugs had pregnancy category by FDA and 245 by ACPM system. 232 drugs had pregnancy category defined by both classifications (FDA and ACPM). We found 70,2% of them in the same pregnancy category. CONCLUSIONS: The discrepancies found in both pregnancy categorisation systems can be confused in order to prescribe and know its safety statement of medicines during pregnancy which can limits its utility. It would be desirable more studies after medicines registered to get more information which could help to use safety drugs during pregnancy and minimize discrepancies between both pregnancy categorisation systems. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
Authors: A Cubillo; S Morales; E Goñi; F Matute; J L Muñoz; D Pérez-Díaz; J de Santiago; Á Rodríguez-Lescure Journal: Clin Transl Oncol Date: 2020-11-16 Impact factor: 3.405