Pharma & Drug Safety

Keppra (Levetiracetam) Syringe Change and Medication Error Risk

Swissmedic and UCB-Pharma AG are issuing a communication regarding a change in the application syringe for Keppra (Levetiracetam) oral solution. A new 5 ml syringe replaces the 3 ml syringe for children aged 6 months to 4 years, requiring healthcare professionals to inform caregivers about the change and proper dosing to prevent medication errors.

Voxzogo (vosoritidum) Packaging Text Error Identified

Swissmedic has identified a packaging text error on Voxzogo (vosoritidum) outer packaging. The incorrect dosage information was printed on specific batches, and affected batches have been identified. The company has issued an information letter detailing the error and corrective actions.

Yttrium Citrate (90Y)-YMM-1 Failed Sterility Test

Swissmedic has issued a communication regarding Citrate d'Yttrium (90Y)-YMM-1, Suspension for Injection, batch Z008. The batch failed its sterility test after incubation. While no immediate patient danger is expected, affected patients require close monitoring.

Cytosar (cytarabinum) Barcode Expiry Date Discrepancy Alert

Swissmedic has issued a Health Professional Communication regarding a barcode expiry date discrepancy for Cytosar (cytarabinum) 2g/20ml, batch CT32407B. The date encoded in the 2D barcode on the vial label is incorrect and does not match the legible expiry date printed on the vial.

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.

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.

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.

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.

EMA CHMP Meeting Minutes July 2025

The European Medicines Agency (EMA) has published the minutes from the Committee for Medicinal Products for Human Use (CHMP) meeting held from July 21-24, 2025. The document details discussions and opinions on various medicinal products, including initial applications and re-examinations.