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AndroGel manufacturers Abbot Laboratories and subsidiary AbbVie already face a number of personal injury lawsuits in the U.S. concerning their testosterone replacement products. Plaintiffs typically claim the companies failed to provide adequate warnings about the cardiovascular risks.

Now, plaintiffs in Canada have filed a new class-action lawsuit against the drug makers, as well. They claim that not only did Abbot fail to warn doctors and the public about the increased risk of heart attack and stroke, but also overpromoted the product, running misleading advertisements that misrepresented the actual symptoms of low testosterone or hypogonadism.

Health Canada Investigates Risk of Testosterone Therapy

The FDA issued an announcement in January, noting that they were investigating the risk of stroke, heart attack, and death in men taking testosterone products. They later scheduled an advisory panel to further examine the issue in September, 2014.

On July 15, 2014, Health Canada published the results of their own safety review of testosterone replacement products. They noted that they had “observed a growing body of evidence suggesting a possible association between the use of testosterone replacement products and cardiovascular risk.”

They go on to explain that testosterone replacement therapy is known to cause an increase in blood pressure, fluid retention/swelling, and may also lead to blood vessel narrowing and blood clots. The Canadian label already warns users about a possible increase in blood pressure and fluid retention and swelling, particularly in those who already suffer from other heart problems, but it says nothing about increasing risk of heart attack or stroke.

Updating Product Labels for Testosterone Products

As part of their investigation, Health Canada reviewed the current scientific literature, international safety data, and adverse reaction reports submitted by patients and doctors. Since August 2013, they received 35 reports of cardiovascular problems associated with testosterone products. In their review of the literature, they also noted that in addition to the studies linking testosterone replacement with cardiovascular risk, some cases noted that the risk disappeared after the patient stopped using the product.

After their investigation, Health Canada concluded, “The current available evidence suggests the possibility that cardiovascular problems, other than those already identified, may occur with the use of testosterone replacement products.” They also noted that prescriptions of these products have increased over the past several years, and is most commonly given to men aged 40 to 59 years.

They then stated that they are working with manufacturers to update product label warnings, that they had warned the public about the risks, and that they are collaborating with other regulators, including the FDA and European Medicines Agency, regarding future safety actions.

Class Action Lawsuit Against AndroGel

Canadian plaintiffs filed a class-action lawsuit against manufacturers of AndroGel in June of 2014. The company faces a number of other lawsuits in the United States. The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated all federal cases into the Northern District of Illinois.

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