Since March 27, the Dijon pharmacovigilance center is responsible for listing all the reported adverse reactions in connection with drugs used in patients treated for COVID-19 infection. One hundred of adverse effects were reported, including 82 serious cases and 4 cases of death. The majority of reported adverse reactions are split in half between the lopinavir-ritonavir combination and hydroxychoroquine. “Most of the observed effects are known: hepatotoxicity, nephrotoxicity, retinal damage, cardiovascular disorders in particular “underlines the ANSM.”The existence of these cardiovascular risks led us to set up a second survey, conducted by the Nice pharmacovigilance center, dedicated to these particular events “.
This first assessment shows that the risks, in particular cardiovascular, associated with these treatments are indeed present and potentially increased in patients with COVID-19. 53 cases of cardiac adverse effects were thus analyzed, including 43 cases with hydroxychloroquine, alone or in combination (in particular with azithromycin).
They are classified into three categories:
- 7 cases of sudden death, including 3 “recovered” by external electric shock
- About ten electrocardiographic arrhythmias or cardiac symptoms
- Conduction disorders including prolongation of the QT interval, which progresses favorably after discontinuation of treatment.
Plaquenil: a collective of liberal doctors wants to prescribe it
Almost 4 million (3,987,854 exactly) boxes of Plaquenil (hydroxychloroquine) were sold in France between January 1, 2017 and December 31, 2019 (30 tablets dosed at 200 mg per box). During this period, the National Medicines Safety Agency (ANSM) collected the spontaneously reported adverse events and analyzed them, in order to conclude, as it does for any drug, whether the declared effect was attributable or not. in Plaquenil During this period, 312 side effects were recorded by the ANSM, including 21 cardiovascular events (6.7%): 4 cases of heart failure, 8 cases of cardiomyopathy, 8 cases of arrhythmia in the broad sense and 1 case of pulmonary hypertension.
“The vast majority of the undesirable effects reported are ocular and cutaneous-mucosal effects, those which are usually described during long-term treatment with hydroxychloroquine” underlines the group of doctors # Covid19-Let doctors prescribe. Based on this ANSM study, but also on the results of other international studies who are examining the effectiveness of Plaquenil delivered early to patients with Covid-19, the group of private and hospital doctors is calling for the freedom to prescribe hydroxychloroquine to their patients showing symptoms of the coronavirus.
“Compared to the volume of prescriptions, these pharmacovigilance data do not explain the prescription restrictions imposed by the General Directorate of Health, and this in comparison with pharmacovigilance data, which is more worrying, of certain over-the-counter drugs “, underline the doctors.
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