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.

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.

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.

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 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.

EMA CHMP Meeting Agenda February 2026

The European Medicines Agency (EMA) has published the draft agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for February 23-26, 2026. The agenda outlines topics for discussion, including pre-authorisation and post-authorisation procedures for various medicinal products.

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.

MHRA Safety Roundup February 2026: Falsified Mounjaro Pens

The MHRA has issued a safety alert regarding falsified Mounjaro KwikPen 15mg pre-filled pens found in the UK. The affected pens, batch number D873576, have faulty mechanisms and should not be supplied or used. Healthcare professionals are advised to quarantine and return affected stock.

Pflaumer et al v. ACE Hardware Corporation - Civil Case Filing

A new civil case, Pflaumer et al v. ACE Hardware Corporation, has been filed in the U.S. District Court for the Northern District of California. The case, bearing number 5:26-cv-02151, was filed on March 12, 2026, with a filing fee of $405. The initial filings include the complaint, proposed summons, and a certificate of interested entities.

GLP-1/GIP Agonists: Strengthened Pancreatitis Warnings

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated product information for GLP-1 and dual GLP-1/GIP receptor agonists to strengthen warnings about the risk of severe acute pancreatitis, including necrotising and fatal cases. Healthcare professionals are advised to be vigilant and report suspected adverse reactions.