In a press release published on Thursday, January 30, 2025, the National Agency for the Safety of Medicines (ANSM) requests that treatment with quetiapine no longer be initiated due to severe supply tensions.
The increasing difficulties in accessing drugs based on quetiapine, used to treat schizophrenia, bipolar disorder and severe depression, have prompted the French National Agency for the Safety of Medicines (ANSM) to react.
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In a press release published Thursday, quoted by Le Figaro, she asks doctors “to no longer initiate treatments with extended-release quetiapine, except for patients presenting a depressive episode characterized in the context of a bipolar disorder”. The ANSM specifies that in all other indications, alternatives must be favored.
Marketed in France for fifteen years, quetiapine has been experiencing strong supply tensions across all dosages since September. This unprecedented situation is explained by “a production problem” encountered by the manufacturer Pharmathen International, supplier to several laboratories.
“This molecule from the antipsychotic family is prescribed to treat severe patients over the long term, for whom abrupt cessation of treatment can potentially be very serious”, emphasizes Professor Antoine Pelissolo, head of the psychiatry department at Henri-Mondor hospital in Créteil, to our colleagues.
Recommended substitution treatments
Several substitution treatments are recommended by the ANSM, which also invites pharmacists to consult the prescriber when a patient presents with a prescription for quetiapine that is impossible to honor.
However, even if other drugs can be proposed, “adapting to a new drug often requires adjustments and takes time, because the effectiveness and side effects vary greatly from one patient to another”, explains Professor Pelissolo.
Faced with this shortage, the ANSM introduced a quota on deliveries in September to ensure fair distribution between pharmacies. Export to foreign wholesalers is also prohibited.
“Drug shortages have been part of the daily lives of patients, pharmacists and doctors for several years, but this time it affects an essential molecule, the shortage of which can lead to real danger for patients”, warns Professor Pelissolo.