France's ANSM Restricts New Fluoxetine Starts to Children and Adolescents Amid Supply Tensions
核心洞察
France's ANSM (搜索) reported temporary manufacturing difficulties affecting fluoxetine medicines, including Prozac and generics, in 20 mg capsules and tablets, with pharmacy supply expected to normalize in mid-October.
New treatment initiations should be reserved in priority for depressive episodes in children from age 8 and adolescents, to preserve continuity for patients already on treatment.
Since early September, quantitative rationing and an export ban on fluoxetine have been in force, and the agency asked all laboratories to release all available stocks, including safety stock.
France's national medicines agency has placed restrictions on new prescriptions of fluoxetine as manufacturing problems constrain supply of the antidepressant, sold as Prozac and in generic form.
In a statement issued on 25 September, the Agence nationale de sécurité du médicament et des produits de santé (ANSM (搜索)) said medicines containing fluoxetine, in capsule and tablet form, are affected by supply tensions linked to temporary production difficulties. The agency expects a return to normal availability in pharmacies in mid-October.
Priority for pediatric and adolescent patients
To allow patients already on treatment to continue without interruption, the ANSM (搜索) asked that treatment initiations be reserved in priority for depressive episodes in children from the age of 8 and in adolescents. Fluoxetine is the only antidepressant indicated for the treatment of certain depressive episodes in children from age 8, according to the agency. It is also indicated for major depressive episodes, obsessive-compulsive disorder (搜索) and bulimia (搜索).
The agency said pediatric and adolescent patients therefore become the priority group when supply is under severe strain.
Rationing and export ban in force
Since the start of September, quantitative rationing and a ban on export have been in force. The measures are intended to secure supply within France and preserve available stocks. Wholesale distributors, which mainly supply pharmacies and play a strategic role in medicine supply, are barred from selling and exporting the drug abroad.
The ANSM (搜索) also asked all laboratories to increase their supply capacity by making available all of their available stocks, including safety stock. The agency said it is monitoring equitable patient access to the medicines from the laboratories.
Laboratories concerned have confirmed to the ANSM (搜索) that industrial supplies will be made available again at the end of September, which the agency expects to translate into normalized pharmacy availability in mid-October. The affected products are the 20 mg capsules and tablets.
Wider psychiatric supply pressures
Fluoxetine is not the first widely prescribed psychiatric medicine to face supply difficulties in France. Quetiapine, used in schizophrenia (搜索), and lithium salts (搜索), used in bipolar disorder (搜索), were both affected by supply problems in 2025, according to the ANSM (搜索). The agency attributes such shortages to varied causes, including the offshoring of active pharmaceutical ingredient production and a pricing system that the pharmaceutical industry sometimes considers insufficiently remunerative.