Seven generic drugs withdrawn from the French market due to irregularities

Seven generic drugs withdrawn from the French market due to irregularities
Seven generic drugs withdrawn from the French market due to irregularities

Par Le Figaro with AFP

4 hours ago,

Update 2 hours ago


France was to decide on the status of 72 drugs at the request of the European Union. In the end, 7 drugs were immediately withdrawn from the market.

Seven generic drugs will be immediately withdrawn from the French market because their effectiveness was poorly assessed, the drug agency announced on Wednesday, granting a two-year grace period to dozens of other potentially affected treatments.Indeed, an immediate suspension of these drugs would have created a critical situation, due to their indications and the lack of available therapeutic alternatives.“, explains the National Agency for the Safety of Medicines (ANSM) in a press release. Generics are drugs whose basic molecule, the active substance, has fallen into the public domain. Their manufacture is therefore no longer reserved for the owner of their patent.

The European Commission had asked EU states at the end of May to suspend the authorisation of around 400 generic drugs, judging that their effectiveness had been poorly assessed by the Indian subcontractor Synapse. But it had left open the possibility of suspending it for two years, in the event of a risk of shortages.

In France, where more than 70 references were concerned, the majority of them will benefit from this delay: this concerns about forty. They are used in cardiology, cancerology, in cases of HIV infection… For about twenty other treatments on the list, the manufacturers have already submitted new studies deemed satisfactory by the ANSM. There remain six treatments, produced by the Arrow and Almus laboratories, whose authorization the agency immediately withdraws and requests a recall from pharmacists.

Read alsoMedicines: shortages persist in pharmacies

Withdrawals that could be temporary

According to documents sent to AFP by the ANSM, for Arrow, these are olanzapine, a treatment for schizophrenia for which three packagings are concerned – and nevirapine, used in cases of HIV infection. For Almus, these are the antidiabetic metformin and the painkiller tramadol. These withdrawals could only be temporary, if the manufacturers provide satisfactory studies.

What is the risk for patients who have taken these treatments or will continue to take those that have not been suspended to avoid shortages? The potential danger is having a treatment that is less effective than expected, even if the ANSM specifies that at present no problem of this type has been identified.The risk seems absolutely measured to us.“, the Agency’s director general, Alexandre de la Volpilière, told AFP. Even the treatments affected by an immediate suspension will be able to be kept by patients who still have them at home, as the recall only concerns pharmacies.



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