Health Canada Orders Label Change For Testosterone Drugs In July 2014: Must Warn About Increased Risks Of Side Effects Including Blood Clots, DVTs, PEs
(Posted by Tom Lamb at DrugInjuryWatch.com)
The safety issues concerning the popular testosterone replacement therapy (TRT) products AndroGel, Axiron, and Testim continue to be be debated with mixed decisions in different arenas.
We will start with the FDA, which on July 17, 2014 issued this "September 17, 2014 Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement":
Agenda: The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.
We note that the Bone, Reproductive and Urologic Drugs Advisory Committee was formerly known as the Reproductive Health Drugs Advisory Committee.
Next, on July 15, 2014 Health Canada issued this "Information Update - Possible cardiovascular problems associated with testosterone products":
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....
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...
Strictly Confidential, No Obligation.
Last but not least -- just to make sure you do not surmise the tide is only going against testosterone products like AndroGel, Axiron, and Testim -- back in mid-May 2014 we found this article, "Testosterone therapy not associated with myocardial infarction, stroke':
Testosterone therapy did not increase the risk of myocardial infarction or stroke and may provide a cardioprotective factor, a presenter at the AACE 23rd Annual Scientific & Clinical Congress said....
... Robert S. Tan, MD, MBA, of the Low T Institute in Dallas, Texas, professor of family and community medicine at University of Texas and associate professor of medicine in geriatrics at Baylor College of Medicine, said during his presentation. “Our study showed that perhaps carefully monitored testosterone replacement therapy may actually protect from heart attacks and stroke.”
We look forward to seeing what will transpire at the upcoming September FDA testosterone Advisory Committee meeting while we continue to watch for developments relevant to the safety issues concerning AndroGel, Axiron, Testim, and the other testosterone replacement therapy / TRT / "Low-T" drugs that have gotten increasingly popular in recent years.