ADR that result in revision of patient information
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| Canada: New heart warnings for the drug Sensipar (cinacalcet) |
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Health Canada has completed a safety review of the drug Sensipar (cinacalcet) that identified a possible link between the drug and abnormal heart rhythm associated with low blood calcium. New warnings have been added to the labelling information advising of this risk.
Sensipar is used for treating disorders of the parathyroid gland that result in abnormal blood calcium levels. Sensipar is well known to cause lower-than-normal levels of blood calcium (hypocalcemia). The risk of low blood calcium associated with the use of Sensipar is clearly outlined on the Canadian drug label. Low blood calcium can cause electrical changes in the heart known as “QT prolongation” and abnormal heart rhythm (arrhythmia). Arrhythmia can be serious and, in some cases, may lead to sudden death.
QT prolongation and arrhythmia have been reported in a small number of patients with low blood calcium treated with Sensipar. Health Canada has reviewed all available information.
It is difficult to determine with certainty what role Sensipar may have played in the development of QT prolongation or arrhythmia, as other risk factors were present at the same time. However, given the effect of low blood calcium on the heart, the possibility of developing QT prolongation or arrhythmia with the use of Sensipar could not be ruled out.
Health professionals are advised to monitor patients for signs of low blood calcium, and prescribe Sensipar with caution in patients with other risk factors for QT prolongation, such as known congenital long QT syndrome (an inherited heart condition), or in patients who are taking other drugs known to cause QT prolongation. For patients treated with Sensipar for chronic kidney disease and receiving dialysis, reduce dose or stop use if low blood calcium, signs of QT prolongation, or arrhythmia continue. For these patients, Sensipar should not be started if they have severe hypocalcemia.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../36267a-eng.php
In Hong Kong, there are two registered pharmaceutical products containing cinacalcet, namely Regpara Tab 25mg (HK-58066) and 75mg (HK-58067). They are prescription-only medicines. So far, the Department of Health has not received any adverse drug reaction report in relation to the drug. In view of Health Canada’s latest recommendations, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, October 16, 2013
Issued at HKT 12:30 |
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