News and communications from MHRA
- Over 3 million medicines and devices seized in UK as part of global crackdown
- The MHRA concludes positive safety profile for Pfizer/BioNTech vaccine in 12- to 15-year-olds
- PT jailed for sale of steroids and unlicensed medicines online
- One-dose Janssen COVID-19 vaccine approved by the MHRA
- Pfizer/BioNTech COVID-19 vaccine shelf-life extended from 5 to 31 days, says MHRA
- Regulator seeks views on reclassification of pain medication
- MHRA response to JCVI advice on COVID-19 Vaccine AstraZeneca for people aged under 40
- UK medicines regulator issues its first authorisation under Project Orbis
- MHRA announces appointment of Chief Safety Officer
- New commissioners appointed to the Commission on Human Medicines
- MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots
- Early Access continues during the coronavirus (COVID-19) pandemic
- MHRA pilots patient involvement in new applications
- UK regulator confirms that people should continue to receive the COVID-19 vaccine AstraZeneca
- Further MHRA response to the precautionary suspensions of COVID-19 Vaccine AstraZeneca
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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