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Temporarily allow hydroxychloroquine? The French Medicines Agency says no to Raoult

2020-10-23T13:21:58.140Z


The Marseille microbiologist wanted to prescribe this drug on a massive scale to all his patients, with reimbursement, despite the


The Medicines Agency (ANSM) on Thursday refused a request addressed to it by Professor Didier Raoult: the authorization in a temporary context of the wide use of hydroxychloroquine to treat Covid-19.

"We cannot respond favorably to the request for RTU (temporary recommendation for use, Editor's note) for hydroxychloroquine in the management of Covid-19 disease", indicates the ANSM in an information point. online on its website.

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"To date, the available data, which are very heterogeneous and uneven, do not allow us to predict a benefit from hydroxychloroquine, alone or in combination, for the treatment or prevention of Covid-19 disease", argues t -she.

"In this context and in view of the available safety data showing increased risks, in particular cardiovascular risks, a favorable benefit / risk ratio cannot be assumed for hydroxychloroquine whatever its context of use", adds the agency.

The National Medicines Safety Agency is also publishing an eight-page letter sent to the Marseille microbiologist, in response to his request.

The RTU, a device to be judged "on a case by case basis"

This medication is available in France under the name Plaquenil but for other pathologies (rheumatism, certain lupus ...).

The prescription by a doctor of a medicinal product outside the indications provided for by the marketing authorization (MA) must be done "on a case-by-case basis", informing the patient of the benefits and risks incurred and of the non-reimbursement, and the words “off-label” must appear on the prescription.

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The temporary recommendation for use (RTU), which gives access to reimbursement, aims for a massive prescription outside the MA, beyond the prescription on a case-by-case basis.

Hence the request from the IHU in Marseille, which has a large number of patients.

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The health agency specifies that "this position could be revised" if it was provided with new convincing clinical studies.

Source: leparis

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