ADR that result in revision of patient information
|
| |
| The United Kingdom: Drug safety update: Hydroxyzine (Atarax, Ucerax): risk of QT interval prolongation and Torsade de Pointes |
| |
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
When using hydroxyzine, healthcare professionals are advised of the following:
• Do not prescribe hydroxyzine to people with a prolonged QT interval or who have risk factors for QT interval prolongation as described above.
• 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/hydroxyzine-atarax-ucerax-risk-of-qt-interval-prolongation-and-torsade-de-pointes
In Hong Kong, there are 16 registered pharmaceutical products containing hydroxyzine, and they are prescription-only medicines. Related news has been released by the EMA, and was posted on the Drug Office website on 9 May 2014, 14 February 2015 and 28 March 2015. Letter to healthcare professionals was issued on 16 February 2015 to draw their attention to the warning. So far, the Department of Health (DH) has not received any adverse drug reaction report on hydroxyzine. As previously reported on 28 March 2015, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The DH will remain vigilant on any safety updates of the drug and regulatory actions taken by other overseas drug regulatory authorities.
Ends/ Thursday, April 30, 2015
Issued at HKT 14:00
GlaxoSmithKline Limited (GSK) is the registration certificate holder of three branded pharmaceutical products containing hydroxyzine, namely Atarax Film-coated Tab 25mg (HK-24218), Atarax Film-coated Tab 10mg (HK-24239) and Atarax Syrup 10mg/5ml (HK-24243). GSK notified the DH that the company is going to issue a "Dear Healthcare Professional Letter" today to inform the local healthcare professionals about the new restrictions for hydroxyzine-containing medicines to further minimise the known risk of QT prolongation. The DH will maintain close contact with GSK to monitor any action deemed necessary. As previously reported, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Content last updated: Thursday, July 16, 2015
|
| |
|
