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6 changes Guidance, last 7 days

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MHRA Guidance on Medicine Reclassification for Improved Access

The MHRA has published guidance discussing the potential benefits of reclassifying medicines to improve patient access to treatments and reduce pressure on NHS services. The guidance highlights opportunities for self-care and innovation within the consumer healthcare sector.

Routine Guidance Healthcare
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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.

Priority review Guidance Pharmaceuticals
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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.

Priority review Guidance Pharmaceuticals
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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.

Priority review Guidance Pharmaceuticals
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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.

Priority review Guidance Pharmaceuticals
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MHRA Approves Deuruxolitinib (Leqselvi) for Severe Alopecia Areata

The UK's MHRA has approved deuruxolitinib (Leqselvi) for the treatment of severe alopecia areata in adults. This marks a new treatment option for patients and will be kept under close review for safety and effectiveness.

Routine Guidance Pharmaceuticals

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