2024-01-12 19:18:27
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.
In an article published in the February edition of the journal Biomedicine & Pharmacotherapy and highlighted by the news outlet Politico, French researchers estimate the number of deaths in hospitalized COVID-19 patients that could be linked to hydroxychloroquine during the first corona wave. 16,990 deaths in six countries. This concerns Belgium, France, Italy, Spain, Turkey and the United States. In Belgium, the death toll is estimated at 240 deaths.
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 medicine 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.
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However, further studies showed 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, which was published in The Lancet, but from which the medical journal later distanced itself, hospitalized corona patients treated with hydroxychloroquine were even more likely to die.
The use of hydroxychloroquine to treat COVID-19 has been advised in Belgium since April 7, 2020, mainly in hospitalized COVID-19 patients in the context of clinical trials. On May 26, 2020, the guideline was amended: off-label use for hospitalized COVID-19 patients is no longer recommended, except in ongoing clinically registered trials. 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.
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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 COVID-19 patients and the conditional use of hydroxychloroquine was recommended for mild to moderately ill COVID-19 patients,” the FAMHP explains.
The dose used and the combination with other treatments affected the safety of the medicine in treating COVID-19. A Sciensano study, published in 2020 in the journal 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 COVID-19 patients,” the FAMHP states. In fact, lower mortality was seen among hospitalized COVID-19 patients treated with hydroxychloroquine. The researchers judged that further studies were needed.
The guideline 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. “The off-label use of medications or experimental treatment against COVID-19 is reserved for hospitalized patients,” read the procedure for general practitioners in the event of a possible case of COVID-19, which was published that day.
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