ANSM requests safety stock mobilization

The French National Agency for the Safety of Medicines and Health Products (ANSM) has asked laboratories to use safety stocks of duloxetine 30 mg and 60 mg and for doctors to limit starting new patients on the drug, as supply issues are expected to last until mid-November 2026. Labs have told the ANSM that normal distribution should resume by that time.

Supply disruptions due to production issues

The problems with getting duloxetine to pharmacies have been ongoing for several months because of temporary production problems. All companies that sell duloxetine are affected, and the ANSM is urging them to use their safety stocks to get as many boxes of the drug to pharmacies as possible.

Logistical measures to ensure supply

The main actions involve logistical steps for the affected laboratories, such as prioritizing the supply of pharmacies through wholesale distributors and avoiding direct sales until normal supply is restored. Laboratories and wholesale distributors are also banned from exporting medicines containing duloxetine.

Prescribers asked to limit new prescriptions

To ensure patients who are already on duloxetine can continue their treatment, the ANSM is asking doctors to stop starting new patients on the drug and to consider other medications. For depression and anxiety, doctors are encouraged to use other antidepressants, especially those in the serotonin and norepinephrine reuptake inhibitor class. For diabetic nerve pain, alternatives like gabapentinoids or tricyclic antidepressants are recommended.

Duloxetine and its medical uses

Duloxetine is an antidepressant in the class of serotonin and norepinephrine reuptake inhibitors. It is used to treat major depressive disorder, generalized anxiety disorder, and pain caused by diabetic nerve damage.