Hydroxyzine (Atarax, Ucerax): risk of QT interval prolongation and Torsade de Pointes
The maximum adult daily dose of hydroxyzine is now 100 mg. Do not prescribe hydroxyzine to people with a prolonged QT interval or risk factors for QT interval prolongation.
When using hydroxyzine:
- do not prescribe hydroxyzine to people with a prolonged QT interval or who have risk factors for QT interval prolongation (see below)
- avoid use in the elderly - they are more susceptible than younger patients to the side effects of hydroxyzine
- consider the risks of QT interval prolongation and Torsade de Pointes before prescribing to patients taking medicines that lower heart rate or potassium levels
- the maximum daily dose is now
- 100 mg for adults
- 50 mg for the elderly (if use cannot be avoided)
- 2 mg per kg body weight for children up to 40 kg in weight
- prescribe the lowest effective dose for as short a time as possible
- continue to report any suspected side effects to hydroxyzine or any other medicine on a Yellow Card
Hydroxyzine is an antihistamine used to treat pruritus in adults and children and anxiety in adults.
A European review of the safety and efficacy of hydroxyzine has been undertaken following concerns of heart rhythm abnormalities associated with this medicine. The review concluded that hydroxyzine is associated with a small risk of QT interval prolongation and Torsade de Pointes. Such events are most likely to occur in patients who already have risk factors for QT prolongation, such as:
- concomitant use of medicines that prolong the QT interval
- cardiovascular disease
- family history of sudden cardiac death
- significant electrolyte imbalance (low potassium or magnesium levels)
- significant bradycardia
Further information
sent to healthcare professionals in April 2015
European Medicines Agency announcement March 2015
Article citation: Drug Safety Update volume 8 issue 9 April 2015: 1