Duloxetine shortages in Luxembourg: causes, consequences and action by the authorities

On 15 April 2025, the commercialisation of Cymbalta®, Yentreve® and Prozac® containing duloxetine and fluoxetine - important substances in the treatment of depression and other neuropsychiatric diseases - will be officially stopped in Luxembourg. This was reported to the Ministry of Health by the manufacturer Eli Lilly Benelux back in October 2024. Although the situation was predictable, the consequences were tangible: a temporary shortage appeared on the market.

The decision to stop the sale was formally handed down on 8 October 2024 and the actual end date was set for 15 April 2025. Almost immediately thereafter - on 28 October - the Health Directorate sent out a notice to stakeholders, including physicians and pharmacists. A special letter explaining the situation, agreed with Eli Lilly, was approved for distribution on 18 December 2024.

It is noteworthy that the cessation of supply is not related to the safety or quality of the medicines - the reason lies in the manufacturer's decision to withdraw these products from the Luxembourg market.

Although the original drugs are going away, nine generics of duloxetine sold by Viatris remain on the market. However, they previously held only a small share of the market, leading to an unexpected strain on supply. The result is disruptions in availability and shortages in pharmacies.

As duloxetine is not on the EU list of critical medicines, it is not subject to the stricter control measures. The same applies to the French classification MITM - Médicaments d'Intérêt Thérapeutique Majeur.

However, the Ministry of Health states that in case of complete unavailability at the national level, pharmacies have the right to import analogues from neighbouring countries. In addition, there is a special team within the Directorate of Pharmacy and Medicines (DPM) to monitor and respond to shortages.