Notification of adverse reactions in a sentinel hospital of Fortaleza – Ceará

Abstract

This article aims to describe the reports of suspected adverse drug reactions in a sentinel hospital in Fortaleza, Ceara state, and retrospective descriptive study that used as a secondary source, the notification form of suspected adverse reactions to drugs the pharmacovigilance system in 2007. There were 116 reports involving 269 drugs and 204 reactions. Only 0.9% of notifications were made spontaneously. The age group ranged from 2 to 87 years with an average of 33 (± 20.1) years. The adverse reactions mainly men (81.9%), between 15 and 29 years (42.4%). The main drugs involved were metamizol (32.8%) and cephalothin (27.6%). It was also found that the integumentary system (59.3%) and gastrointestinal system (13.2%) understood the systems most affected by adverse reactions. The most frequent reactions included urticaria (23.3%), pruritus (16.8%), skin rash, abdominal pain and allergic processes (5.9% each). Also has reported serious adverse reactions such as Steven Johnson syndrome (3.9%). It was noted the need for more investment in this area, especially in relation to awareness of the importance of spontaneous reporting to obtain data necessary for purposes of health regulations.