ADR that result in revision of patient information
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| Canada: Celexa (citalopram) - Association with abnormal heart rhythms |
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Lundbeck Canada, in collaboration with Health Canada, would like to inform you that the antidepressant Celexa® (citalopram hydrobromide; also marketed as generics), should no longer be used at doses greater than 40 mg per day due to study results indicating a dose-dependent potential for QT prolongation. A randomized, double-blind, placebo- and positive-controlled, crossover study was performed in healthy subjects (N=119) to examine the effects of citalopram 20 mg/day and 60 mg/day on electrocardiogram (ECG) intervals when administered according to an escalating multiple dose regimen (9 days at 20 mg/day, 4 days at 40 mg/day, 9 days at 60 mg/day). The maximum mean differences from placebo were 8.5 (10.8) and 18.5 (21.0) msec for 20 mg and 60 mg citalopram, respectively. The effects of the 40 mg/day dose were not studied, but are predicted to be approximately 13 msec. Changes in the electrical conductivity of the heart (prolongation of the QT interval on the ECG) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients should be advised to contact a healthcare professional immediately if they experience signs and symptoms of an abnormal heart rate or rhythm while taking Celexa® (citalopram hydrobromide). These include dizziness, palpitations, syncope or seizures. The Canadian Product Monograph for Celexa® (citalopram hydrobromide) has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/celexa_2_hpc-cps-eng.php
In Hong Kong, In Hong Kong, a total of 17 citalopram-containing products are registered and all are prescription-only medicines. The above safety news has been released by the US FDA, Health Canada and Australia TGA and was posted on the website of the Drug Office on 25 August 2011, 15 October 2011 and 4 November 2011. A letter for healthcare professionals was issued on 25 August 2011. The matter was discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board on 6 September 2011. The Committee decided that the labelling of products containing citalopram should include the safety information regarding the abnormal heart rhythm associated with high doses of citalopram and that the maximum daily dosage of citalopram is 40mg per day.
Ends/ Tuesday, January 31, 2012
Issued at HKT 12:30 |
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