Information Update: New Heart Warnings for the Drug Sensipar
(firmenpresse) - OTTAWA, ONTARIO -- (Marketwired) -- 10/15/13 -- 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, including one case involving the death of a . Health Canada has reviewed available information, including this case.
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
Additional information for healthcare professionals
Report health or safety concerns
- Call toll-free at 1-866-234-2345
- Visit MedEffect Canada's Web page on for information on how to report online, by mail or by fax
Related Advisories, Warnings and Recalls
- March 7, 2013 -
Egalement disponible en francais
Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
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Datum: 15.10.2013 - 13:44 Uhr
Sprache: Deutsch
News-ID 1272794
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