• Vitor Costa Ferreira, Gustavo Costa Ferreira, and André Oliveira Baldoni.
• Campus Centro-Oeste Dona Lindu (CCO), Federal University of São João Del-Rei (UFSJ), Divinópolis, Brazil.
• J Eval Clin Pract. 2020 Jun 1; 26 (3): 957-961.

Rationale, Aims, And ObjectivesAs a pharmacovigilance measure, the Brazilian Health Regulatory Agency (ANVISA) monitors the postmarketing events of medication and issues alerts on actions to be taken and information updates. The present study has the objective of analysing the profile of all the alerts on medication issued by ANVISA between 2006 and 2018.MethodsA descriptive documentary analysis was carried out through the ANVISA website and double checked with two researchers in order to avoid discrepancies in data collection and interpretation of information.ResultsA total of 79 alerts available in the period were analysed, the mean being 6.07 alerts/year and standard deviation of 3.81. The medications most cited in the alerts were antivirals (9.7%), followed by antidiabetics (7.3%) and contraceptives (7.3%). The main problems identified were adverse reactions (50%) and other problems related to safety (15%). The main actions directed by ANVISA were generation of a new contraindication (37.3%) and alteration in the package insert (22.3%).ConclusionAlerts are an important means of communicating new information to health professionals and to society. However, they need better standardization in order to facilitate understanding, dissemination in order to broaden access to information, and studies to corroborate the current literature and improve current pharmacovigilance.© 2019 John Wiley & Sons, Ltd.

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