Drug Safety

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.

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.

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.

Falsified Mounjaro KwikPen 15mg Pens Found in UK

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a notice regarding falsified Mounjaro KwikPen 15mg pre-filled pens found supplied through an online pharmacy. Batch number D873576 is affected, and the pens have a faulty mechanism, posing a safety risk to patients.

Semaglutide Drug Linked to Optic Neuropathy Risk

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding a rare risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) associated with semaglutide (Wegovy, Ozempic, Rybelsus). Healthcare professionals are advised to refer patients with sudden vision loss for ophthalmological examination and to consider discontinuing semaglutide if NAION is confirmed.

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.

Chikungunya Vaccine (IXCHIQ) Use Restrictions Updated

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has updated restrictions for the IXCHIQ Chikungunya vaccine following a safety review. The vaccine is no longer indicated for individuals over 60 and is contraindicated for those with hypertension, cardiovascular disease, diabetes, or chronic kidney disease.

Isotretinoin Prescribing Guidance Updated

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated prescribing guidance for isotretinoin, removing the requirement for a second prescriber for patients under 18. New risk minimisation measures, including an updated Acknowledgement of Risk Form, have been introduced to ensure safe prescribing.

Cerliponase alfa for Neuronal Ceroid Lipofuscinosis Type 2 Guidance

NICE has published updated highly specialised technologies guidance (HST34) on cerliponase alfa (Brineura) for treating neuronal ceroid lipofuscinosis type 2 in children. This guidance replaces previous guidance and confirms that patients already receiving treatment can continue.