The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2018 (PDF).
This issue advises of a small increased risk non-melanoma skin cancer seen in association with hydrochlorothiazine. The risk is cumulative and dose-dependent and as such is seen more after long-term use. Patients taking such medicines should be advised to regularly check for and report any new or changed skin lesions or moles. Sensible exposure to sunlight and UV rays, including using adequate protection should also be advised. Use in patients with a history of skin cancers should be reconsidered.
This issue also reports a small increased risk of aortic aneurysm and dissection, particularly on older patients, using fluoroquinolones. These antibiotics should only be used after careful consideration in patients at risk of aortic aneurysm and dissection, for example those with a family history, pre-existing aortic aneurysm or dissection and diseases that increase the risk such as Marfan syndrome, Ehlers-Danlos syndrome and hypertension.
It is also reported that a clinical study of sildenafil (Revatio® and Viagra®) in early-onset intrauterine growth restriction has been terminated early after reports of persistent pulmonary hypertension of the newborn (PPHN). It is noted that sildenafil is not licensed for this condition and that Revatio is not recommended in pregnancy unless strictly necessary while Viagra is not authorised for use in women.
A Europe wide campaign is running from 19–23 November 2018 to support the safe use of medicines in babies, children, and pregnant and breastfeeding women. Social media will be used to discuss the importance of reporting suspected side effects via the Yellow Card Scheme.
Also this month, the summary of letters to healthcare professionals includes information about expiry date extension of Jext® adrenaline autoinjectors, a reminder of the advice about phenytoin (Epanutin®) 30mg/5ml oral suspension supply disruption and shortage of sodium valproate modified release (Epilim Chronosphere®▼). CoaguChek Test Strips have also been found to give false high readings and it is recommended that readings above 4.5 are confirmed using a laboratory method or unaffected batches of test strips before adjusting treatment.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.