Thirteen years of medication alerts issued by the Brazilian Health Regulatory Agency (ANVISA): What is the profile?

Abstract

Rationale, aims, and objectives: As 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.Methods: A 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.Results: A 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%). Conclusion:Alerts 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.

Characteristics of drug safety alerts issued by the Spanish Medicines Agency

“…The results of this study show that the Spanish Medicines Agency issued, on average, one or two drug safety alerts every month from 2013 to 2019, one out of five of these were alert duplications. The rate of alert issuance did not increase over time in this period, contrary to other studies conducted in Portugal and the Netherlands ( Soares et al, 2015 ; Ferreira et al, 2020 ). Almost half of the alerts were issued by the national medicines agency, and some were subsequently issued by the EMA, indicating that the SEFV-H is a proactive local safety system and an effective national signal detection system that anticipates alerts issued by the PRAC ( Farcas et al, 2020 ).…”

“…In addition, the most frequent types of ADRs in this analysis were infections and neoplasms, which are type A effects related to the mechanism of action of antineoplastic agents, the most frequent drug class alerted, and consequently, these ADRs are frequent and predictable. In contrast to other studies, the drugs most frequently addressed in the alerts reported in this study were antidepressants, antidiabetics, anti-infectives, and anti-inflammatory drugs (Farcaş et al, 2018;Ferreira et al, 2020;Perry et al, 2020;Meddra, 2021). Hepatitis, death, and congenital malformations were the most frequent ADR alerts with the first two being the most frequently reported ADRs in other studies (Farcaş et al, 2018;Meddra, 2021).…”

“…Some of the reported ADRs in this study were sufficiently serious and clinically important enough to require changes to their labeling or to be classified with an unfavorable benefit/risk ratio, leading to their withdrawal from the market. Changes or updates in the SmPC were frequent regulatory actions for almost half of the medicines in this and other studies (Lester et al, 2013;Ferreira et al, 2020;Perry et al, 2020). This was specifically true for nationally authorized drugs, which are more likely to be updated than EU-authorized products (van Hunsel et al, 2021).…”

“…This was specifically true for nationally authorized drugs, which are more likely to be updated than EU-authorized products ( van Hunsel et al, 2021 ). In contrast, drug withdrawal tended to be infrequent and occurred in approximately 5%–7% of alerted drugs, with several prior informational alerts preceding the suspension of the medicine ( Soares et al, 2015 ; Ferreira et al, 2020 ). In our study, most of these drugs had been available in the Spanish market for decades.…”

“…In a recent study comparing drug safety alerts issued by national medicine regulators in Australia, Canada, the United Kingdom, and the United States from 2007 to 2016, major differences were found in the use of safety advisories by regulators, including their frequency, content, communication type, and focus (Perry et al, 2020). However, few previous studies have analyzed the characteristics of safety alerts issued by regulatory authorities, though data are available for a few other countries, including Portugal, the Netherlands, Brazil, and the Ivory Coast (Ferreira et al, 2020;Soares et al, 2015;Mol et al, 2010;N'Guessan-Irié et al, 2012). To our knowledge, no research has been published regarding alerts specifically issued by the Spanish Medicines Authority.…”