Notifications for adverse effects of covid kit drugs soar in 2020; Anvisa has already registered 9 deaths

BRASILIA – Notifications for adverse effects resulting from the use of “covid kit” drugs such as chloroquine and hydroxychloroquine in 2020 have skyrocketed in comparison with the previous year. At least nine deaths have been reported, all after March 2020, after the start of the Covid-19 epidemic in the country. In the case of chloroquine, a drug recommended by President Jair Bolsonaro, the increase in notifications due to adverse effects was 558%. The data are contained in a survey carried out by GLOBO based on the Pharmacovigilance Notification Panel maintained by the National Health Surveillance Agency (Anvisa). The increase was also registered in relation to other drugs in the so-called “covid kit”, composed of drugs with no proven efficacy against Covid-19. The comparison between the 2019 and 2020 data also shows a change in the ranking of the most notified substances. In 2019, chloroquine was ranked seventh on the list of drugs responsible for reporting adverse effects. In 2020, chloroquine moved to the top position.

Anvisa’s panel reproduces the notifications received from all over Brazil about adverse effects related to the use of some type of medication. It is part of VigiMed, a computerized notification system implemented in December 2018 by the agency. An adverse effect is an unexpected reaction from the patient after receiving a specific medication. These notifications can be made both by, companies, professionals and health service and also by the patients themselves. According to Anvisa, the notifications are “suspicious” and not all are investigated. Also according to the agency, despite the notifications being associated with a certain drug, the adverse effects recorded may be related to other substances.

The platform shows that there was a general increase in the number of adverse effect notifications between 2019 and 2020. In the period, the number of notifications related to all drugs went from 8,587 in 2019 to 19,592 in the following year, an increase of 128%. Despite the growth in general data, the increase related to drugs such as chloroquine and azithromycin is higher than the average.

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The so-called “covid kit” is a group of drugs supplied by the federal government to states and municipalities in which remedies are ineffective against Covid-19. The GLOBO survey considered the following remedies: chloroquine, hydroxychloroquine and hydroxychloroquine sulfate, azithromycin and ivermectin.

According to the panel, notifications of adverse effects associated with the use of chloroquine went from 139 in 2019 to 916 in 2020, a variation of 558%. According to the data, adverse effects related to the use of chloroquine led to the notification of a death. Chloroquine has been defended by President Bolsonaro in the treatment of Covid-19 despite scientific studies proving that it is not effective against the disease. In May last year, the Ministry of Health issued a guideline for the use of chloroquine, hydroxychloroquine and other drugs since the initial symptoms of Covid-19. The guideline has been widely criticized by experts in the field.

Of the total adverse events reported, 96% are concentrated in Amazonas, one of the states that suffered the most from the pandemic. Among the main adverse effects reported are: disorders of the nervous, gastrointestinal, psychiatric and cardiac systems. In March, GLOBO showed that teams from the Ministry of Health took a tour of 13 basic health units in Manaus, amid the collapse of the Amazonian system, preaching “early treatment”. The case led to the opening of an investigation by the Federal Public Ministry.

Other drugs that had an increase in the number of reports of adverse effects were hydroxychloroquine and hydroxychloroquine sulfate. According to the panel, in 2019, no notification had been recorded about the use of these drugs. In 2020, however, 168 notifications were registered. According to the panel, eight deaths were recorded as a result of using the drug. Among the main effects reported are: tachycardia, nausea, vomiting and dizziness. The state that most concentrated the notifications was São Paulo, with 44% of the total.

Azithromycin, which is also part of the kit, also recorded an increase in the number of reported adverse effects. In 2019 there were 25. In 2020, the number jumped to 82, a variation of 228%.

Another member of the “covid kit” that has seen an increase in the number of notifications is ivermectin. This Wednesday, the National Health Organization (WHO) recommended that the drug not be used in the treatment of Covid-19. According to the Anvisa panel, in 2019, there were no notifications related to the drug. In 2020, there were 11. Recently, doctors warned that at least four patients who made indiscriminate use of ivermectin were referred to the liver transplant queue.

– The only product authorized by Anvisa for the treatment of Covid-19 disease is Remdesivir, which can be administered in the in-hospital environment. It is important to stress that no medication is risk-free. And these risks can be aggravated by indiscriminate use and without professional guidance. This goes for all medicines – said the general manager of Monitoring Products Subject to Health Surveillance at Anvisa, Suzie Gomes.

– The evaluation of possible adverse events is a routine in the area of ​​pharmacovigilance and is an important stage of the safety assessment, but it is not the only one – said Suzie Gomes.

GLOBO questioned the Ministry of Health whether the ministry intends to review the guidance issued in May on the use of drugs against Covid-19, but the ministry did not respond. The Ministry of Health stated that it is attentive and “following all updates and publications regarding the treatment of covid-19 around the world.” According to the Ministry, the creation of an advisory council with representatives “from the academy and associations linked to the medical class” is planned to assist the portfolio in combating the pandemic. “We reinforce that the guidance and recommendation of the Ministry of Health is that, at the first signs of covid-19, patients seek a Basic Health Unit (medical post) for medical care. The measure is fundamental to avoid serious cases of the disease. Finally, we reinforce the need for the use of masks and frequent hand hygiene “, said the organ.

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