Análise de informações técnico-científicas em bulas de medicamentos anticonvulsivantes utilizados na gravidez Analysis of information in technical-scientific in package inserts of anticonvulsant drugs used in pregnancy

The aim of this study was to analyze the technical and scientific information contained in the package inserts of anticonvulsant drugs, as the potential risks and pharmacological changes during pregnancy. Insufficient information regarding the pharmacological procedures and possible risks of four drugs (valproic acid, carbamazepine, phenytoin and diazepam) used as anticonvulsants were analyzed, comparing the data obtained in the inserts of drugs with scientific information disseminated in the research literature and legislation package directions current. Data collection was performed with the investigation of sections Patient Information and Information for Health Professionals of the package inserts obtained in dictionaries pharmaceutical specialties (DEF), official sites of the manufacturers them selves or institutions engaged in health activities. One package inserts, 100% had absence of the item changes in the pharmacokinetics of antiepileptic drugs during pregnancy; regulation of doses to pregnant women and classification of the drug as the risk category for pregnant women. In the detail, warnings and risks in pregnancy and lactation, 40% of the inserts analyzed were considered incomplete for not having the potential teratogenic risk to the fetus. The risks of self-medication and treatment interruption were absent in about 33% of the package inserts and analyzed, about 40% of these had information about drug interactions with contraceptives. Therefore, the information provided in sections Patient Information and Health Professionals Information (or Technical Information), in their majority, were unsatisfactory as information material for pregnant women, according to the criteria considered.