- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Drug Safety Update - April 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2015 (PDF).

The maximum dose of hydroxyzine in an adult is restricted to 100mg due to an increased risk of QT interval prolongation and Torsade de Pointes. It is also recommended that hydroxyzine is not prescribed to people with a prolonged QT interval or who have risk factors for QT interval prolongation, for example those on other medicines that prolong QT interval, those with cardiovascular disease, family history of sudden cardiac death, significant electrolyte imbalance (low potassium or magnesium levels) or significant bradycardia. It is also advised to use the lowest effective dose for the shortest time possible.

Codeine is not recommended for use in children aged under 12 years old due to the risk of respiratory side effects. It is not recommended in those aged 12 to 18 years who have problems with breathing. The MHRA have received 26 Yellow Card reports of respiratory side-effects associated with the use of codeine in children up to 5 August 2014.

The European Medicines Agency is consulting on guidance to minimise the risk of medication error with high strength insulins. Until recently all insulins came in a standard strength of 100 units/mL. Several new insulin products have come to market recently; three high strength insulins which have concentrations greater than 100 units/mL (Tresiba®, Humalog®, Toujeo®), a fixed combination of insulin degludec and liraglutide (Xultophy®) and a biosimilar of insulin glargine (Abasaglar®). Extreme care should be taken when prescribing and dispensing these products to ensure that the patient is given the correct strength.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.