Canadian Regulator Warns against Taking Testosterone Drugs Without Hormone Testing
A class of “Low T” testosterone drugs now involved in several U.S. lawsuits has caught the watchful eye of Health Canada, which recently warned about their alleged potential to cause serious heart and blood vessel problems.
According to a CBC News report on July 15th, the regulator included AndroGel, Androderm, Andriol, Delatestryl, Axiroin, Testim in a recent alert that followed a country-wide investigation of the products.
“Health Canada has recently completed a safety review on testosterone replacement products,” the agency said in a statement that day.
Among other things, the study found an increased risk of heart attack, stroke, blood clot in the lungs or legs and a possibly irregular heart rate in men taking the prescription therapies. Labeling on these “Low T” products will soon be adjusted to reflect these risks, Health Canada said before reminding the public about certain safety information related to the medications.
For one, men should not use one of the hormone-raising therapies in the absence of laboratory testing that proves they are suffering from abnormally low testosterone levels. They should also not be prescribed for non-specific symptoms, which may include fatigue, low libido and other signs of aging.
Health Canada Warns against Testosterone Drug Use in Children, Women
Additionally, children under the age of 18 should not be taking AndroGel, Axiron and similar medications, as the safety and effectiveness of these products has not been tested on this demographic. Women should not be taking “Low T” medications, either.
Health Canada’s recent warning follows a similar one from the U.S. Food and Drug Administration (FDA), who alerted the public earlier this year of cardiovascular side effects that may stem from use of the testosterone therapies. In a federal alert issued on January 31, the regulator warned that two separate studies had found a link between use of AndroGel and similar medications and the risk for heart attacks, strokes, and sudden cardiac death. The FDA reiterated that no link between the two had been confirmed, but that the agency’s review was ongoing.
Since then, a federal multidistrict litigation (MDL) involving “Low T” testosterone products has been established in the U.S. District Court, Northern District of Illinois. Plaintiffs involved in this litigation, which included at least 156 lawsuits in July, allege similar injuries caused by AndroGel, AndroDerm and other products.
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