03/22/2021 7:42 PM
Clarín.com
Society
Updated 03/22/2021 7:42 PM
The European Medicines Agency (EMA)
advised against the use of the antiparasitic ivermectin
in the prevention or treatment of coronavirus.
This drug
is already used in several provinces of Argentina
, despite the fact that the Anmat did not authorize it.
The EMA "concluded that the available data
does not support its use
for Covid-19 outside of clinical trials," the Amsterdam-based agency said in a statement on Monday.
Further studies "are necessary to draw conclusions on the efficacy and safety of the product in the prevention and treatment of Covid-19," the EMA added.
The use of this medicine as a treatment against Covid-19 is not authorized in the European Union, and the EMA did not receive "any request for such use," the European regulator said.
Ivermectin is a broad spectrum antiparasitic agent in human and veterinary medicine.
In in vitro tests it showed its potential as an inhibitor of the SARS-CoV-2 virus.
It became important when some clinical investigations showed to provide a significant reduction in the risk of contagion and in the mortality of the positives.
In Argentina
Controversy remains open in the scientific community about the therapeutic use of ivermectin in the prevention and treatment of coronavirus.
Although the National Administration of Food, Drugs and Medical Technology (ANMAT) has not yet approved it and different infectologists have objected to its use,
several provinces decided to test it
.
In Misiones, the Ministry of Public Health authorized the use of ivermectin in patients with Covid-19 admitted to public hospitals in January.
The disseminated protocol details that they will receive a dose of 0.6 mg per kilo and per day, over five days.
In mid-March, the provincial health portfolio reported the delivery of the second delivery of the drug (
about 50 thousand treatments
) to different hospitals.
Tucumán is also applying ivermectin.
They began to use it in October, within so-called “off label” studies, in which a drug that is authorized for something else is used for one purpose.
They began to give it within a protocol, in volunteers.
This Monday, for example, the health authorities reported that they administered the medication to a group of young people, from three contingents, in which 45 positive cases were detected.
At the end of January, La Pampa joined.
The province uses ivermectin for COVID-positive treatments, in cases of early diagnosis.
At the end of February, it reported the purchase of more than 7 thousand treatments.
Also Corrientes, Salta and Jujuy did tests with this antiparasitic in patients with Covid-19.
Like the EMA, the Argentine Society of Infectious Diseases - several of whose members advise the national government - had already issued a rejection of the use of ivermectin.
"Until now, the scientific evidence in progress evaluating the use of ivermectin alone or in combination with other drugs for the prevention and / or treatment of SARS-Cov2 infection is of very low quality and no clear clinical efficacy data has been reported" said the entity.
A study in Argentina
A study carried out by Argentine doctors Héctor Carvallo and Roberto Hirsch concluded that the drug is
an effective adjuvant method
for personal protective equipment in the prophylaxis of SARS-CoV-2 in health personnel and their contacts.
Therefore, they recommend implementing it in vulnerable population groups: geriatric and psychiatric institutes, orphanages and prisons, among others.
“It is not an experimental treatment.
Even in the United States there is a presentation before the Senate that requests the authorization of ivermectin ”, he affirms to Hirsch.
There are already more than 10,000 patients treated, followed and reviewed by this drug.
In an interview published in Clarín, the experts detailed that a meta-analysis that registered 25 trials in different countries of the world - in total it included 2,045 participants as prophylaxis and 1,835 Covid positive - showed a decrease in the mortality rate of around 65% ( in severe and late) and 92% (in earlier use of the drug), according to the time and stage of the disease in the treated patients.
DD