The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2018 (PDF).
This issue notes that oral lidocaine-containing products for infant teething are now only to be available under the supervision of a pharmacist. This is to ensure that appropriate guidance about managing infant teething symptoms can be given and lidocaine-containing products only be used when simple measures have failed to provide sufficient relief.
This issue also reports that compliance with the new valproate measures for pregnancy prevention currently appears to be variable by CCG. All healthcare professionals must continue to identify and review all female patients on valproate and provide them with the patient information materials every time they attend their appointments or receive their medicines.
Readers are also advised the packaging and patient information leaflets for emollients will soon be updated warning about the risk of severe and fatal burns. These warnings are being are being extended to all paraffin-based emollients regardless of paraffin concentration and also for paraffin-free emollients where there is still a risk.
This issue also notes that direct-acting antivirals for chronic hepatitis C have been associated with an increased risk of hypoglycaemia in patients with diabetes. It is suggested the glucose levels are monitored more closely, particularly in the first 3 months of treatment, with diabetic treatment adjusted accordingly.
Also, this issue advises that hydrocortisone muco-adhesive buccal tablets should not be used off-label for adrenal insufficiency in children. This is due to serious risks of insufficient cortisol absorption and life-threatening adrenal crisis. Licensed hydrocortisone products for adrenal replacement therapy are available and should be used.
Finally this month, the summary of letters to healthcare professionals includes a letter circulated about the risk of aortic aneurysm and dissection, particularly on older patients, using fluoroquinolones and notification that Quadrivalent Influenza Vaccine (under the brand name VaxigripTetra®▼) intended for export to Europe has been authorised for use in the UK to satisfy higher than expected demand.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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