Other safety alerts
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| The United States: Celexa (citalopram hydrobromide): Drug Safety Communication - abnormal heart rhythms associated with high doses |
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FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm
In Hong Kong, a total of 17 citalopram-containing products are registered and are prescription-only medicines. In view of FDA's recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, August 25, 2011
Issued at HKT 12:30
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