EMA: New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines

Use to be avoided in patients at greatest risk and doses to be kept low The CMDh1 has agreed by consensus new measures to minimise the risk of effects on heart rhythm with medicines containing the antihistamine hydroxyzine. The measures include restricting use of hydroxyzine in patients at high risk of heart rhythm problems and using the medicine at the lowest effective dose for as short a time as possible. Hydroxyzine medicines are available in most EU countries. Their approved uses (indications) vary between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and treatment of sleep disorders.

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