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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.

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.

NICE Guidance: Pegzilarginase for Arginase-1 Deficiency

NICE has published guidance recommending pegzilarginase (Loargys) for treating arginase-1 deficiency in individuals aged 2 years and over. The guidance includes evidence-based recommendations and details a commercial access agreement for the treatment.

NICE Guidance: Setmelanotide for Bardet-Biedl Syndrome

The UK's National Institute for Health and Care Excellence (NICE) has published highly specialised technologies guidance on setmelanotide (Imcivree) for treating obesity and hyperphagia in Bardet-Biedl syndrome. The guidance provides evidence-based recommendations for patients aged 6 years and over, with specific criteria for treatment initiation.

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.

NICE Guidance: Olipudase alfa for Niemann-Pick disease types AB and B

NICE has published highly specialised technologies guidance (HST32) on the use of olipudase alfa (Xenpozyme) for treating Niemann-Pick disease types AB and B. The guidance provides evidence-based recommendations for healthcare professionals and commissioners in the UK.

NICE Guidance: Leniolisib for PI3K delta syndrome

NICE has published highly specialised technologies guidance on the use of leniolisib (Joenja) for treating activated phosphoinositide 3-kinase delta syndrome in individuals aged 12 and over. The guidance includes evidence-based recommendations and information on commercial arrangements for NHS organisations.

Baloxavir marboxil appraisal terminated for children

NICE has terminated the appraisal of baloxavir marboxil for treating and preventing influenza in children aged 1 to 11 years. The decision was made because the company failed to provide an evidence submission for the technology appraisal.