Du 13 au 19 décembre 2024, l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) a mis à jour ou signalé des perturbations concernant la disponibilité de divers médicaments distribués à la fois dans les pharmacies de ville et les hôpitaux en France.
Sommaire
Tensions sur l’approvisionnement d’ENDOXAN 50 mg
Le comprimé enrobé ENDOXAN 50 mg (cyclophosphamide)
Situation actuelle selon l’ANSM
- Disponibilité restreinte en pharmacie de ville
- Quantités limitées disponibles
- Date de normalisation de la distribution non spécifiée
Nouvelle tension sur les stocks d’ESPERAL
Tablette ESPERAL 500 mg (disulfirame)
État de disponibilité selon l’ANSM
- Manque en ville, suite à une courte période de disponibilité (voir notre article du 17 septembre 2024)
- Quantités distribuées limitées
- Remise à disposition espérée pour mi-février 2025
Report de la remise à disposition d’IPRATROPIUM TEVA 0,5 mg jusqu’en janvier 2025
Solution IPRATROPIUM TEVA 0,5 mg/2 mL pour inhalation par nébuliseur, en récipients unidose (ipratropium)
État de disponibilité selon l’ANSM
- Rupture de stock en pharmacie de ville
- Possibilité de compensation par d’autres laboratoires
- Remise à disposition retardée à janvier 2025, initialement prévue en septembre (voir notre article du 12 mars 2024)
Indisponibilité prolongée de LASILIX RETARD
Gélules LASILIX RETARD 60 mg (furosémide)
État de disponibilité selon l’ANSM
- Persistent shortage of supply (see our article from December 10, 2024)
- Limited distribution
- No expected date for normal resupply
LUTRELEF treatment initiations to be halted
LUTRELEF 3.2 mg powder and solvent for solution for injection (gonadorelin)
Availability status according to ANSM
- Tension in city pharmacies
- Limited distribution due to Lutrepulse system tension
- Halting of treatment initiations
- Resupply expected by September 2028
Additional information from the laboratory
Laboratory information letter to healthcare professionals (December 13, 2024): tension in LUTRELEF caused by a long-term stockout (upcoming) of the LUTREPULSE administration system:
- following the definitive cessation of manufacturing by the supplier of the LUTREPULSE system, the laboratory has only a very limited stock of LUTREPULSE kits (stock depletion estimate Q2 2025) expiring at the end of February 2026. The laboratory indicates that it is making every effort to develop a new system for the administration of LUTRELEF;
- no new treatments with LUTRELEF/LUTREPULSE should be initiated. Other market solutions exist (all drugs for the induction of ovulation for the treatment of sterility in anovulations of hypothalamic origin);
- quantitative rationing of 2 LUTREPULSE kits (10 auto-injectors) per order, implemented in December 2024.
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The reconstituted solution of LUTRELEF 3.2 mg is administered in a pulsatile manner thanks to the LUTREPULSE system. This system consists of two elements (medical devices provided separately):
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METHYLPHENIDATE ARROW LP: all 4 dosages under tension
METHYLPHENIDATE ARROW LP 10 mg, LP 20 mg, LP 30 mg, and LP 40 mg extended-release capsule
Availability status according to ANSM
- Supply tension for all 4 dosages
- Limited distribution
- Recommendations for pharmacists (see our article from November 5, 2024)
- No expected date for normal resupply
MYDRIATICUM single-dose eye drops: no date for normal resupply
MYDRIATICUM 2 mg/0.4 mL eye drops in a single-dose container (tropicamide)
Availability status according to ANSM
- Supply tension
- No expected date for normal resupply, instead of September (see our article from August 6, 2024)
VITAMIN B12 DELAGRANGE: imported units, for the hospital market and for injectable use only
VITAMIN B12 DELAGRANGE 1000 µg/2 mL injectable (IM) and oral solution (cyanocobalamin)
Availability status according to ANSM
- Stockout
- Exceptional and temporary availability of units of the specialty Vitamin B12 Léciva 1000 μg, injection solution, initially intended for the Slovak and Czech markets starting December 13, 2024
- These imported units are reserved for hospital use and cannot be retroceded
- In the city: maintenance of qualitative rationing
- Injectable and drinkable Vitamin B12: prefer tablets to ampoules for oral use
- No expected date for normal resupply
Additional information from the laboratory
Letter from the laboratory to hospital pharmacists
- the specialty being serialized in these territories, it is requested that hospital pharmacists decommission the boxes before use;
- the imported specialty is reserved for injectable use;
- the packaging volumes are different between the specialties: the imported specialty is packaged in a 1 mL ampoule (2 mL for the French specialty);
- the concentrations between the two specialties are not identical. However, the amount of vitamin B12 per ampoule is equivalent in the imported specialty and the French specialty: 1,000 micrograms.
VITAMIN B12 GERDA: update on distribution to hospitals
VITAMIN B12 GERDA 1000 µg/4 mL injectable (IM) and oral solution (cyanocobalamin)
Availability status according to ANSM
- Supply tension
- Qualitative rationing
- Distribution from the depository to hospitals remains assured to meet needs
- Injectable and drinkable Vitamin B12: prefer tablets to ampoules for oral use
- No expected date for normal resupply
Additional information from the laboratory
Letter from the laboratory to retail pharmacists, hospital pharmacists, general practitioners, and hematologists from November 20, 2024
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VITAMIN B12, injectable (IM) and oral solution: reserve for patients with a prescription mentioning intramuscular administration or written by a hospital specialist in oncology, hematology, or competent in oncology;
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specific instructions are indicated according to the patients’ issues in a table for doctors and pharmacists.
Specialties back to normal availability
The ANSM has confirmed the normal resupply of the following specialties:
- HUMALOG 100 U/mL injectable solution in a 10 mL vial (insulin lispro), since December 18, after several months of tension in the city (see our article from June 6, 2024)
- LENALIDOMIDE MYLAN 20 mg capsule, since December 18, after a few days of tension
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