Information Update - Possible cardiovascular problems associated with testosterone products

Starting date:

July 15, 2014

Posting date:

July 15, 2014

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-40587

• Issue
• What you should do
• Report health or safety concerns
• Media enquiries
• Public enquiries

Issue

OTTAWA – 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. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.

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. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

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.
• They should not be used by women.

What you should do

• Before using testosterone products, advise your healthcare professional if you have cardiovascular (heart or blood vessel) problems or a history of these problems. 
• Tell your healthcare professional if you experience any of the following: chest pain or discomfort; shortness of breath; sudden numbness in the face, arm or leg; sudden difficulty speaking or understanding; trouble with walking or seeing; headache, light-headedness, dizziness; rapid pulse; sweating; coughing up blood; swelling or pain in the leg (including ankle and foot); changes in skin color (e.g., turning pale, red or blue); a fluttering in your chest, a racing heartbeat, fainting or near fainting.
• Talk to a healthcare professional about any questions or concerns regarding your testosterone therapy.

What health professionals should do

• Before starting testosterone therapy, patients should be assessed for any cardiovascular risk factors, such as existing ischaemic heart disease, or prior history of cardiovascular events (e.g. myocardial infarction, stroke, or heart failure).
• Patients on testosterone therapy should be closely monitored for possible serious cardiovascular events.

Related products

Summary Safety Review - Testosterone Replacement Products - Cardiovascular Risk

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709