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Daily Mail
6 days ago
- Health
- Daily Mail
Urgent warning as epilepsy prescription drug taken by tens of thousands slapped with 'defect' notice
Health officials have issued an urgent warning over a daily medication taken by tens of thousands of patients with epilepsy. UK medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) stuck an alert on batches of Topiramate Zydus 20mg/ml oral solution. It is feared the prescription drug was packaged incorrectly as instructions on how to take the medication correctly are missing. But the MHRA, which published the alert, said the batches with the 'defect' should still be dispensed and prescribed by health professionals. Instead, patients must be advised to shake the bottle well prior to opening it and before each use. The alert only impacts three batches of the drug, manufactured by Zydus Pharmaceuticals UK. Batch numbers TPR24001 and TPR24002, both 280ml have an expiry date of June 2026. Batch number TPR24003, meanwhile, which is 150ml, has an expiry date of September 2026. The liquid oral medication is normally started on a low dose before it is slowly increased. Health officials urged patients, however, not to stop taking the drug without medical advice. 'Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before,' the MHRA said. The medicine 'should not cause harm if taken without shaking', the health watchdog added. But any patients who experience an adverse reaction or have questions about the recall should seek medical attention. Adverse reactions should also be reported via the MHRA's Yellow Card scheme. The scheme, set up in the 1960s, allows doctors, pharmacists and patients themselves to report adverse reactions believed to be caused by prescription and over-the-counter drugs, implants and alternative medicines. This can lead to them being reviewed, having warnings added to the label or even being taken off the market. Around one in 100 people, or 630,000 in the UK, have epilepsy. It's characterised by bursts of uncontrolled electrical activity in the brain, which prevents nerve cells from signalling to each other properly—triggering seizures that can last for several minutes. The main treatment is anti-epileptic drugs, which make brain cells less 'excitable' and less likely to misfire. In more severe cases, surgery may be needed—to remove a small part of the brain that's causing the attack, or to implant a tiny device that interrupts the chaotic signals between nerve cells.
Medscape
23-05-2025
- Health
- Medscape
NICE Recommends First Subcutaneous Option for Haemophilia B
The National Institute for Health and Care Excellence (NICE) has recommended marstacimab (Hympavzi, Pfizer) for treating severe haemophilia B. The treatment is advised for patients aged 12 years and over who weigh at least 35 kg and do not have factor IX inhibitors. It is the first subcutaneous injection for this condition. The treatment was approved by the Medicines and Healthcare products Regulatory Agency last month. How Marstacimab Works Marstacimab is administered weekly. It works by targeting tissue factor pathway inhibitor (TFPI), a protein that prevents blood from clotting. By reducing TFPI levels, marstacimab promotes the formation of thrombin, helping to increase clotting and stop bleeding. About 255 people in England live with severe haemophilia B, defined by a factor IX activity level below 1%. NICE estimates that around 205 patients will be eligible for marstacimab. People with haemophilia B currently receive factor IX replacement therapy by infusion, sometimes every 2-3 days. Gene therapy is also available, following approval by NICE last year. The final draft guidance is based on results from the BASIS study, a phase 3 trial that evaluated marstacimab in 116 adults and adolescents aged 12 years and older with severe haemophilia A or B without inhibitors. Marstacimab significantly reduced the annualised bleeding rate for treated bleeds during the 12-month active treatment period. It demonstrated both noninferiority and statistical superiority compared with routine factor-based prophylaxis. Not Recommended for Haemophilia A While marstacimab can also treat haemophilia A, NICE found it was not cost-effective for this group. It is therefore not recommended for NHS use in these patients. Current treatment options for haemophilia A include factor VIII, emicizumab, and efanesoctocog alfa. 'Marstacimab's clinical and cost-effectiveness compared with current treatment, together with its once-weekly dosing by injection under the skin, means it has the potential to significantly improve the quality of life of people with severe haemophilia B,' said Helen Knight, director of medicines evaluation at NICE. Conan McIlwrath, chair of the Haemophilia Society, welcomed the move. 'This will hopefully help people move towards more individualised treatment plans, based on what best supports the life they choose to live,' he said. Once the final NICE guideline is published, marstacimab could be available to eligible patients as early as this autumn.
