French Market Withdrawals: Drugs Pulled for Poorly Evaluated Effectiveness

2024-07-05 13:35:18

This handful of types will be immediately withdrawn from the French market because their effectiveness has been poorly evaluated, the ANSM announced on Wednesday 3 July. A two-year period is granted for many other potentially affected treatments.

Treatment of schizophrenia, antidiabetic or even tramadol: six drugs will be immediately withdrawn from the market, the Medicines Agency announced on Wednesday 3 July. In question: their poorly rated effectiveness. The ANSM also decided to delay dozens of other treatments by two years, since then “The immediate suspension of these drugs would create a critical situation, given their indications and the lack of other therapeutic options available.”

Arrow and Almus laboratories, based in France, produce the six drugs withdrawn by the ANSM – which also calls for a recall from pharmacists. Firstly, it is olanzapine, a treatment for schizophrenia that involves three packages -, and nevirapine, which is used in cases of HIV infection. On the latter, they are the antidiabetic metformin and the painkiller tramadol. These withdrawals could only be temporary if the manufacturers provide satisfactory studies.

70 references in question in France

This decision follows a request, at the end of May, from the European Commission: it ordered EU states to suspend the authorization of around 400 generic drugs, considering that the Indian subcontractor had misjudged their effectiveness . But opened the possibility of a two-year reprieve in the event of a shortage risk. About 70 references were affected in France. About forty, used in cardiology, oncology, in cases of HIV infection, benefited from this delay. About twenty other manufacturers have already submitted new studies that the ANSM considers satisfactory.

All the treatments in question are generics, that is to say their active substance has fallen into the public eye: they contain the same quantity of this basic molecule as the original treatment, but may have their different size, shape, color or taste. And its manufacture is no longer reserved for the laboratory that owns the patent.

Do not worry about patients who have taken the withdrawn medicines or will continue to take those medicines which have not yet been suspended: “The risk appears to us to be fully measured”, he declared to the director general of the Medicines Agency, Alexandre de la Volpilière. The danger that could exist above all is to have a treatment that is not as effective as expected, even if the ANSM states that no problem of this kind has been identified at the moment. The treatments affected by immediate suspension can also be kept by patients who are still at home: the recall only applies to pharmacies.