Increase in serious side effects when testing for Covid-19 treatments

The drugs used for the Marseille IHU tests. (drawing) – GERARD JULIEN / AFP

Reports of adverse reactions related to treatments tested against Covid-19 have continued to increase in recent weeks, reaching more than 300 cases, announced the Medicines Agency (ANSM), which confirms in particular the “vigilance signal” concerning hydroxychloroquine. “As of April 22, 2020, 321 cases of adverse reactions have been reported in connection with a Covid-19 infection, of which 80% were serious,” said the National Security Agency of
drug, which announced a hundred cases on April 10.

In two-thirds of the cases (215 people), the pharmacovigilance was able to conclude that there was a probable link between the effect observed and the drug administered to the patient with Covid-19. Of these, more than half relate to patients with coronavirus treated with hydroxychloroquine (23%) or with this drug combined with the antibiotic azithromycin (31%), while 42% relate to Kaletra (an antiretroviral combining lopinavir and ritonavir).

Four deaths

The number of deaths observed in this context is still four, all related to hydroxychloroquine and occurring in hospitals. This drug, a derivative of the antimalarial chloroquine, is known to cause electrical abnormalities in the functioning of the heart in some patients, visible on the EKG, which can lead to heart rhythm disturbances or even death.

But it seems that “Covid patients are more fragile cardiovascular and therefore more likely than ordinary people to have problems with drugs that are harmful to the heart” such as hydroxychloroquine, explained the director general ANSM Dominique Martin in early April. The side effects linked to Kaletra are mainly damage to the liver, but also to the digestive system, heart and kidneys.

These reports of side effects do not reflect “the exhaustiveness of the number of cases actually occurred, and this in particular because of the very strong under-notification, but makes it possible to send signals in order to take risk reduction measures », Such as reserving hydroxychloroquine for hospital use, underlines the ANSM. For this reason, it is notably not possible to relate the number of side effects reported to the total number of patients treated to calculate a “risk rate” of each drug, insists the health agency.



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