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Coronavirus: ANSM warns of possible "serious side effects" of treatments

ANSM warns of possible "serious side effects" of treatments
A healthcare professional shows platelets of Nivaquine and Plaquenil, drugs containing hydroxychloroquine, on February 26, 2020 in Marseille GERARD JULIEN AFP / Archives

The Medicines Agency warned on Monday that treatments that have been tested against coronavirus can cause serious undesirable effects and should in no way be used for self-medication, while three deaths related to these treatments have been reported.

"Thirty" serious adverse effects, including "three deaths" have so far been reported in patients with coronaviruses treated with Plaquenil (hydroxychloroquine) but also other medicines such as Kaletra (reversible antiviral combination lopinavir / ritonavir) Dominic Martin, Director General of ANSM, told AFP.

These adverse reactions have been reported mainly to the hospital and analyzes are still underway to verify whether the reported incidents were attributable to the treatment patients receive, in the hope of reaching preliminary conclusions "by that time at the end of the week".

ANSM put under two-week “enhanced monitoring” all treatments that have been tried in coronavirus management, “especially when used outside clinical trials (chloroquine, hydroxychloroquine, azithromycin, lopinavir / ritonavir)., Tocelizumab, colchicine”.

According to Dominic Martin, "It is completely normal to try treatments, given the conditions, but this does not prevent us from exercising drug-alertness and vigilance on these products."

In this regard, hydroxychloroquine coupled with the antibiotic azithromycin has been in the spotlight since Professor Didier Rault published two controversial studies that, according to him, have concluded their "efficacy" against coronavirus deserve "special attention", as noted by the ANSM Director General.

He said that their association "increases the risk of" a heart rhythm disorder, which could lead to a heart attack. This is "healthier in patients with corona virus," due to metabolic disorders in this disease.

Several treatments for coronavirus are currently undergoing clinical trials to assess their effectiveness and the decree has extended their use to other seriously ill patients in hospital.

But "in no way should these drugs be used either for self-medication, or on the basis of a prescription from a city doctor, or on a doctor's prescription for himself, to treat the Corona virus," the agency warns of the safety of the national medicines.

In particular, a group of doctors claimed to "let them prescribe" the right to self-administer this treatment to prove its effectiveness.

Despite the ban on these uses outside the hospital, “it tells us cases of prescribing and dispensing these drugs in pharmacies outside the regulatory framework, especially PlaquĆ©nil,” Dominique Martin worries.

This drug, which is usually used against lupus or rheumatoid arthritis, experienced a "fairly large" increase in sales, with a peak on some days "multiplied by two or three" compared to the pre-epidemic level.

The new regional health agency in Novell-Aquitin issued a similar warning on Sunday, after reports of twelve "serious heart rhythm disturbances with respect to chloroquine self-medication, especially hydroxychloroquine linked to azithromycin".

On Monday, ANSM also published "therapeutic use protocols" to direct hospital doctors to administer hydroxy chloroquine and calitra in hospital to patients with coronavirus who are not used to these molecules, "not using them in their usual connotations."

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