ANSM France News

Wilfactin Supply Tensions: Use Therapeutic Alternatives

ANSM has issued guidance advising healthcare professionals to limit use of Wilfactin (factor Willebrand) to emergency situations and prophylaxis for patients under 18 with contraindications to alternatives, due to ongoing supply tensions at manufacturer LFB. The agency provides a detailed table of therapeutic alternatives (Eqwilate, Voncento, Veyvondi) organized by indication and patient age group.

Emend 125mg Shortage, Alternative Treatments Proposed

ANSM published guidance on April 15, 2026 regarding the shortage of Emend 125mg (aprepitant) oral suspension manufactured by MSD. The drug, used in chemotherapy for children and infants aged 6 months to under 12 years, became unavailable at the end of March 2026 due to production problems. ANSM has arranged alternative supplies including Ivemend 150mg imports and authorized pharmacists to dispense magistral preparations without new prescriptions.

Mektovi (Binimetinib) 15mg and 45mg Dosage Confusion Safety Alert

ANSM issued a drug safety alert regarding Mektovi (binimetinib), an anticancer medication, following 7 reported medication errors from confusion between the 15mg and 45mg tablet dosages. The errors, which began after the 45mg dosage became available in July 2025, resulted in overdoses causing hepatocyte cytolysis, intense fatigue, nausea, serous retinal detachment, and elevated lipase levels. The recommended dose is 90mg/day (either 3 tablets of 15mg or 1 tablet of 45mg twice daily).

Alepsal Unavailable - Therapeutic Alternatives Identified

ANSM announces temporary unavailability of Alepsal (phenobarbital/caffeine anti-epileptic medication) due to supply disruptions affecting all dosages. Manufacturer Teofarma reports difficulties linked to a raw material supplier change, with normal supply expected by summer 2026. Three caffeine-free alternatives have been identified in coordination with the French neurology professional society: Gardenal 10mg and 100mg, and Phenobarbital Richard 100mg.

Rivaroxaban Viatris Lot Recalled Due to Quetiapine Contamination

The French ANSM has ordered a recall of a specific lot (8212020) of Rivaroxaban Viatris 20mg tablets due to cross-contamination with quetiapine. Patients holding this lot are advised to return it to pharmacies for exchange.

ANSM Suspends Institut Georges Lopez, Recalls Celsior Lots

The French ANSM has suspended the manufacturing authorization for Institut Georges Lopez (IGL) and recalled all lots of its organ preservation solution, Celsior, produced since March 2024 due to serious manufacturing non-conformities posing a high risk of microbiological contamination. An update on March 25, 2026, indicates IGL has come into compliance, and its manufacturing authorization has been reinstated.

ANSM Surveillance of Ixchiq Vaccine Adverse Effects

The French National Agency for the Safety of Medicines and Health Products (ANSM) is continuing its surveillance of adverse effects associated with the Ixchiq vaccine, used for chikungunya prevention. This notice serves to inform the public and healthcare professionals about ongoing monitoring activities.

Atropine Eye Drops: Medication Error Risk in Children Under 3

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice regarding the risk of medication errors with atropine eye drops in children under 3 years old. The notice highlights specific risks and provides recommendations to prevent these errors.

COVID-19 Vaccines: Safety Profile Confirmed

The French National Agency for the Safety of Medicines and Health Products (ANSM) has confirmed the safety profile of COVID-19 vaccines. The agency stated that no new safety signals have been identified, reinforcing the established safety of these vaccines.

ANSM Ensures Continuity of Emend 125 mg Oral Suspension for Children

The ANSM has announced measures to ensure the continuity of treatment for children using Emend 125 mg oral suspension due to supply difficulties. Prescribers are advised to reserve the oral suspension for specific pediatric cases and explore alternative formulations for older children and adults. Importations are being arranged to cover demand.

Doliprane Suspension Recall Due to Pipette Wear-Off

The French Agency for the Safety of Medicines and Health Products (ANSM) has announced a recall of 27 lots of Doliprane 2.4% oral suspension due to a manufacturing defect causing pipette graduations to wear off. This defect poses a risk of incorrect dosage and potential overdose in infants and young children.

ANSM Warns of Significant Risks from Off-Label Isotretinoin Use

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a warning regarding the off-label promotion and use of isotretinoin-based medications for aesthetic purposes on social media. The agency emphasizes that these drugs are strictly indicated for severe acne and carry significant risks, including psychiatric disorders and birth defects.

ANSM Recalls Risks of Varicose Vein Sclerosing Agents

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice recalling the serious cardiovascular risks associated with varicose vein sclerosing agents. The agency emphasizes adherence to recommendations and provides new tutorials for reporting adverse events.

PRAC Recommends EU Market Withdrawal of Levamisole Medicines

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of marketing authorizations for medicines containing levamisole from the EU market. This decision is based on a re-evaluation of safety data, concluding that the risks associated with these drugs outweigh their benefits for treating parasitic worm infections.