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Latest MHRA Drug Safety Update - November 2018
Posted on 15 Nov 2018
The latest MHRA Drug Safety Update, November 2018
This month article features are:
- regulatory action taken following 2 observational studies linking hydrochlorothiazide-containing medicines, particularly in long-term use, with an increased risk of non-melanoma skin cancer. See page 2 for measures to minimise risk, including that patients should be advised to limit exposure to, and use adequate protection against, sunlight and UV rays and to be vigilant for suspicious moles and skin lesions.
- advise you to carefully assess the benefits and risks and consider other therapeutic options before prescribing systemic and inhaled fluoroquinolone antibiotics in patients at increased risk of aortic aneurysm and dissection (page 4).
- On page 6, read interim results from the STRIDER clinical trial, which assessed sildenafil during pregnancy in off-label use for intrauterine growth restriction.
- On page 8, we ask you to show your support for the EU-wide ADR awareness week campaign taking place from 19–23 November 2018, by sharing material on social media and discussing the importance of reporting side effects with your colleagues and with patients, parents, and caregivers. This year the key message is that reporting relevant suspected adverse drug reactions to the Yellow Card Scheme helps the safe use of medicines in babies, children, and pregnant and breastfeeding women
- On page 11 and 12, we highlight letters and alerts sent in October 2018, including a letter advising of the extension of use beyond the labelled expiry date for specific lots of Jext adrenaline auto-injectors during the current supply disruption.