After French study that reported “more than 200 Belgian deaths” due to malaria drug against corona: “Only 18 cases of side effects in our country” | Domestic

In Belgium, only 18 cases of suspected side effects have been reported for hydroxychloroquine, the much-discussed malaria drug that was used against Covid-19 during the first corona wave. Belga learned this on Friday from the FAMHP (the Federal Agency for Medicines and Health Products). Yesterday, a French overview study claimed that at the beginning of the corona crisis, more than 200 Belgians died due to the administration of the malaria drug.

In an article published in the magazine Biomedicine & Pharmacotherapy French researchers estimate the number of deaths in hospitalized corona patients that can be linked to hydroxychloroquine during the first corona wave at as many as 16,990 deaths in six countries. This concerns Belgium, France, Italy, Spain, Turkey and the United States. In Belgium, researchers estimate the death toll at 240 deaths.

Deployed during the first corona wave

Hydroxychloroquine is a drug used to treat malaria and rheumatic autoimmune diseases. During the first corona wave, the off-label use (the use for an indication or patient group for which the medicine was not registered) of the drug was proposed as a possible treatment for Covid-19. The drug came into the news after then US President Donald Trump said he was taking hydroxychloroquine against the coronavirus.

Hydroxychloroquine. © AFP

However, further studies found that the risks associated with using hydroxychloroquine to treat Covid-19 did not outweigh the benefits. For example, the international clinical trial RECOVERY (Randomized Evaluation of Covid-19 Therapy) showed an increase in cardiac mortality, the French researchers outline in the article. According to a controversial study published in The Lancetbut from which the medical journal later distanced itself, hospitalized corona patients treated with hydroxychloroquine were even more likely to die.

Risk overestimated

In our country, short-term low-dose treatment with the drug was recommended. The finding by French researchers that seriously ill corona patients who received the drug were eleven percent more likely to die than patients who did not receive the drug, is based on different doses. The risk could therefore have been overestimated.

Hydroxychloroquine.
Hydroxychloroquine. © AFP

The use of hydroxychloroquine to treat Covid-19 has been advised in Belgium since April 7, 2020, mainly in hospitalized corona patients in the context of clinical trials.

On May 26, 2020, the guideline was amended: off-label use for hospitalized corona patients was no longer recommended, except in ongoing clinically registered tests. At that time, eight cases of side effects had already been reported to the FAMHP, including one fatal case in a patient using hydroxychloroquine and sarilumab.

“Great uncertainty at the start of the pandemic”

On Friday, the FAMHP confirmed that a total of eighteen cases of side effects have been reported. It points to the great uncertainty brought about by the pandemic.

“Given the good antiviral effect of hydroxychloroquine that was seen in non-clinical studies that were the first available, given the unavailability of clinical data at the time regarding the effect of hydroxychloroquine against Covid-19, and given the known safety profile of hydroxychloroquine through years of use in chronic diseases, the use of hydroxychloroquine was recommended for seriously ill patients and the conditional use of hydroxychloroquine was recommended for mild to moderately ill patients,” the FAMHP explains.

Archive image of a corona patient in a Belgian hospital in 2020.
Archive image of a corona patient in a Belgian hospital in 2020. © Photo News

Short and low dose

The dose used and the combination with other treatments affected the safety of the medicine in treating Covid-19.

A study by Sciensano, published in the journal in 2020 International Journal of Antimicrobial Agents, “supports the claim that short-term low-dose treatment with hydroxychloroquine monotherapy (2,400 mg for five days) was not associated with an increased short-term risk of cardiotoxicity and mortality in the hospital setting and in selected corona patients,” the FAMHP argues. (A drug or treatment is cardiotoxic if there is a risk of damage to the heart). Even lower mortality was seen in hospitalized corona patients treated with hydroxychloroquine. The researchers judged that further studies were needed.

The guideline in Belgium always mentioned the low dose and always pointed out that patients needed to be monitored to detect serious side effects in time. It was also emphasized that the drug could only be administered in a hospital context. General practitioners have been warned about this since April 22, 2020, health institute Sciensano added on Friday.

Getty Images/Photo News
© Getty Images / Photo News

Calculation

Virologist Marc Van Ranst already qualified the French study yesterday. “In 2020, hydroxychloroquine was an obvious choice,” he said. “Over time, several studies showed that the drug was ineffective. (…) Our country therefore decided to no longer use the drug.

“I think it is difficult to say whether the malaria drug has really cost us 240 lives,” the virologist also argued. “This concerns a calculation based on an international percentage. So it is not only based on our country.”

Also read: More than 200 Belgian deaths due to malaria drug against corona. Van Ranst qualifies: “At that moment it was a logical choice”

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