OTTAWA, ONTARIO--(Marketwired - Oct. 15, 2013) -
This document corrects and replaces the press release that was sent today at 3:44 PM EDT.
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.
Stronger warnings have been added to the drug label to inform patients about the risk of QT prolongation and arrhythmia associated with the use of Sensipar and to advise health professionals to monitor and report heart-related side effects.
What you should do
- Before starting Sensipar, talk to your doctor if you have heart rhythm problems or take medicines known to cause heart rhythm problems or if you have low levels of blood calcium, or have/had heart problems (low blood pressure or worsening heart failure).
- Tell your doctor if you experience an unusually fast or pounding heartbeat.
- Tell your doctor immediately if you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures. These may be signs that your calcium level is too low.
- Talk to your doctor or pharmacist about any questions or concerns regarding your Sensipar treatment.
Additional information for healthcare professionals
- Carefully monitor patients for signs of low blood calcium.
- 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.
Report health or safety concerns
- Call toll-free at 1-866-234-2345
- Visit MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax
Related Advisories, Warnings and Recalls
- March 7, 2013 - Health Canada cautions against use of Sensipar in children
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