Hydroxychloroquine alert. The Medicines Agency (ANSM) warned on Monday that the treatments tested against Covid-19 could cause serious adverse effects and should "in no case" be used for self-medication, while three deaths potentially linked to these treatments have been reported.
“Thirty” of serious adverse effects, including “three deaths” have so far been reported in patients with coronavirus treated with Plaquenil (hydroxychloroquine) but also other drugs such as Kaletra (an antiretroviral combining lopinavir / ritonavir), said Dominique Martin, the director general of the ANSM.
These side effects have been reported mainly to the hospital and analyzes are still underway to verify whether the reported events are attributable to the treatments received by the patients or not, he said, hoping for initial conclusions "from here the end of the week ". The ANSM has placed under "enhanced surveillance" for a fortnight all the treatments experienced in the management of Covid-19, "in particular when used outside clinical trials (chloroquine, hydroxychloroquine, azithromycin, lopinavir / ritonavir, tocilizumab, colchicine) ".
"That doesn't prevent us from having to exercise surveillance"
"It is quite normal that treatments should be tried, given the circumstances, but that does not prevent us from having to exercise surveillance and pharmacovigilance on these products", according to Dominique Martin. In this regard, hydroxychloroquine coupled with the antibiotic azithromycin, under the spotlight since Pr Didier Raoult published two controversial studies concluding in his view to their "effectiveness" against the coronavirus, deserves "special attention", observes the director general of the ANSM.
Their association "potentiates the risk" of heart rhythm disorder "which can lead to a heart attack," he says. And this is "even more true in patients who suffer from Covid", due to metabolic disorders specific to this disease. Several treatments for the coronavirus are currently undergoing clinical trials to assess their effectiveness and a decree has extended their use to other patients in serious condition in the hospital.
"In no case should these drugs be used or for self-medication"
But "in no case should these drugs be used either for self-medication, or on the prescription of a city doctor, or on the self-prescription of a doctor for himself, for the treatment of Covid-19", warns l 'National Medicines Safety Agency. A group of doctors, “Let them prescribe”, has notably demanded the right to self-administer this treatment to demonstrate its effectiveness.
Despite the ban on these uses outside the hospital, "we were told of cases of prescription and dispensing of these drugs in pharmacies outside the regulatory framework, in particular Plaquénil", worries Dominique Martin. This drug, normally used against lupus or rheumatoid arthritis, has experienced a "fairly significant" increase in sales, with some days peaks "multiplied by two or three" compared to the level before the epidemic.
The Nouvelle-Aquitaine Regional Health Agency had issued a similar warning on Sunday, after reports of a dozen "cases of serious heart rhythm disorders related to self-medication taken with chloroquine and especially hydroxychloroquine associated with azithromycin ”.
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The ANSM also published on Monday “therapeutic use protocols” to guide doctors called on to administer hydroxychloroquine and Kaletra in the hospital to patients with Covid-19 who are not used to these molecules, "Not used in their usual indications".
