Other safety alerts
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| Canada: Information Update - Possible cardiovascular problems associated with testosterone products |
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Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.
Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. Health Canada is working with manufacturers to update the Canadian product labels regarding this risk.
Health Canada would like to remind the public of the following important information from the Canadian Product Monographs regarding the use of testosterone products:
- they should not be used in men for non-specific symptoms if laboratory tests have not been done to confirm a low testosterone level and other possible causes for the symptoms have not been excluded;
- they should not be used in children under the age of 18 as the safety and effectiveness has not been established in these patients; and
- they should not be used by women.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../40587a-eng.php
In Hong Kong, there are eight registered pharmaceutical products containing testosterone which are prescription-only medicines. The Department of Health (DH) noted that the US FDA and EMA started reviewing the risk of cardiovascular events of testosterone products and conclusion has not yet been drawn, and the related news was posted on the Drug Office website on 4 February 2014 and 12 April 2014 respectively. Related news on risk of venous thromboembolism has been released by the US FDA, and was posted on the Drug Office website on 20 June 2014. Letter to healthcare professionals was issued on the same day to draw their attention to the matter. So far, the DH has not received any adverse drug reaction report on the drug related to heart failure or cardiovascular complications. In view of the above Health Canada's announcement, letter to healthcare professionals will be issued to draw their attention to the matter and urge them to report any adverse drug reaction related to the drug, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The DH will remain vigilant on any safety updates related to the drug and actions taken by other overseas regulatory authorities.
Ends/ Wednesday, July 16, 2014
Issued at HKT 14:00
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