We bring you the latest news from the healthcare about the health care in the United Kingdom.

dinsdag 25 september 2018

Field Safety Notice - 17 September to 21 September

Field Safety Notice - 17 September to 21 September
List of field safety notices (FSNs) from medical device manufacturers from 17 September to 21 September
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Letters and drug alerts sent to healthcare professionals in August 2018
Letters were sent about daclizumab beta (Zinbryta▼), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo▼ (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nutriflex Lipid Special 2500 ml.
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Nusinersen (Spinraza▼): reports of communicating hydrocephalus; discuss symptoms with patients and carers and investigate urgently
Advise patients and their caregivers to seek urgent medical attention if any signs or symptoms of communicating hydrocephalus develop during nusinersen therapy for spinal muscular atrophy. Patients with communicating hydrocephalus may require treatment with a cerebrospinal fluid (CSF) shunt.
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Daclizumab beta (Zinbryta▼): risk of immune-mediated encephalitis – some cases several months after stopping treatment
Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need to contact their doctor immediately if they occur.
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Xofigo▼ (radium-223-dichloride): new restrictions on use due to increased risk of fracture and trend for increased mortality seen in clinical trial
Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive other systemic treatments. Do not use in combination with abiraterone acetate and prednisone/prednisolone.
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Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers
Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. If you are involved in the care of female patients on valproate in the UK, see a reminder of actions required for this medicine. You should have received a pack of information materials for patients—if you have not yet received a pack, or if you are near to running out of any materials, you should order more using the details provided in the article.
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