News and communications from MHRA
- First bivalent COVID-19 booster vaccine approved by UK medicines regulator
- MHRA and CAP take action against illegal ‘hayfever jab’ adverts online
- Nine new commissioners appointed to the Commission on Human Medicines
- Safety review to begin on topiramate
- Over 285,000 medicines and medical devices seized UK-wide in global action
- Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark MHRA reclassification
- Horizon Scanning Case Study: Point of Care manufacture
- UK to strengthen regulation of medical devices to protect patients
- MHRA joins international partnerships to set global standards for medicines and medical devices regulation
- New safety warnings on risk of insulin leakage from Roche Accu-Chek Insight Insulin pumps
- MHRA approves faricimab through international work-sharing initiative
- Share your views on making a treatment for overactive bladder available for women without need for prescription
- MHRA approves the Moderna COVID-19 vaccine ‘Spikevax’ for use in 6 to 11-year olds
- Valneva COVID-19 vaccine approved by MHRA
- The MHRA are seeking views to strengthen conflicts of interest policy for independent advisors
Alerts and recalls for drugs and medical devices
- Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)
- Masks: type IIR from Cardinal Health – destroy affected lots (MDA/2020/021)
- Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)
- Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)
- Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)
- Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)
- Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)
- Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)
- Pilling Clear Advantage aortic punch – risk of infection due to packaging failure (MDA/2020/014)
- COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)
- Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)
- Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)
- Spinal implant: MAGEC System Model X rods – risk of failure in use (MDA/2020/010)
- Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models
- Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008)
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