With Over 100 Testosterone Lawsuits Awaiting Litigation in the U.S., Health Canada Has Issued A Safety Review Warning of Possible Cardiac Risks Associated With Testosterone Treatment Drugs
Wright & Schulte LLC has learned that Health Canada has issued a warning to patients and healthcare professionals of the potential life-threatening heart and blood vessel problems associated with testosterone replacement therapy products. The Canadian regulatory agency said it is working with testosterone drug manufacturers to update their testosterone therapy product labels to reflect the risk of heart attack, stroke, blood clots in the lungs or legs, and increased or irregular heart rate linked with the use of testosterone medication. Meanwhile in the United States, court documents indicate that the number of lawsuits continue to mount in federal litigation in the U.S. District Court of Illinois against the makers of testosterone replacement therapy products, such as Androderm, AndroGel, Testim and Depo-Testosterone, that all purport men have sustained cardiac events such as strokes and heart attacks due to low testosterone treatment drugs (In re: Testosterone Replacement Therapy Product Liability Litigation – MDL No. 2545)
[healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/40587a-eng.php, July 15, 2014]
Health Canada said in its July 15 safety review that there are 12 testosterone-containing products currently marketed for use as testosterone replacement therapy:
and their equivalent generics.
The firm continues to speak with men who have suffered cardiac issues purportedly from low testosterone treatment drugs such as AndroGel and AndroDerm and encourage anyone who believes they have experienced side-effects from testosterone therapy drugs to contact one of their attorneys at 1-800-399-0795 or visit www.yourlegalhelp.com for a free legal evaluation. You can also like us on Facebook and follow us on Twitter for all the up to date news.
As of August 31, 2013, Health Canada said it had received 35 reports of cardiovascular problems involving low testosterone treatment products. Of the 35 reports, 11 reports that included heart attack, blood clots in the lungs and irregular heart rate were considered possibly related to testosterone products. Health Canada further stated, some of the cardiovascular problems reported went away when men stopped taking the medication but the problems returned when they started taking the testosterone drug again. Health Canada further said it is working with federal regulatory agencies from other countries, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, about the safety concerns over testosterone replacement therapy products.
In January, the FDA launched an investigation into the safety of testosterone replacement therapy drugs after reviewing two studies showing potential cardiovascular problems linked with taking low testosterone medication. A study published in the PLOS One Journal on, found that men over 65 and younger men with a pre-existing heart disease who were prescribed testosterone drugs were at a greater risk of having a heart attack within the first 90 days after taking the medication for the first time. The second study, published in the November 2013 Journal of the American Medical Association, found that older men who had underlying cardiovascular disease and took low testosterone treatment had a 30 percent increased risk of having a stroke, heart attack or death compared to men who did not take the medication.
[fda.gov/Drugs/DrugSafety/ucm383904.htm, January 31, 2014] [plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805, January 29, 2014] [jama.jamanetwork.com/article.aspx?articleid=1764051, November 6, 2013]
In June, the FDA ordered manufacturers of all FDA-approved testosterone products to include a general warning about the risk of venous blood clots on their drug labels. Existing testosterone drug labels already have a warning about blood clots in veins as a consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. The FDA, however, said that post-market reports have shown that blood clots are occurring that are unrelated to polycythemia.
[fda.gov/drugs/drugsafety/ucm401746.htm, June 19, 2014]
Testosterone replacement therapy drugs are used to treat hypogonadism (low testosterone) in men who lack or have low testosterone levels due to an underlying medical condition. Among the FDA-approved testosterone products marketed in the U.S. are AndroGel, Androderm, Delatestryl, Depo-Testosterone, Testim and Testope. Testosterone products are manufactured as topical gels, transdermal patches, and as a buccal system applied to upper gum or inner cheek. Some testosterone drugs are injected.
[fda.gov/Drugs/DrugSafety/ucm383904.htm, January 31, 2014]
According to court records one of the testosterone lawsuits in MDL2545 is an AndroGel lawsuit filed on behalf of a Georgia man who alleges he has had three heart attacks, since January 8, 2013, as a result of taking AndroGel, the low testosterone replacement therapy. The complaint purports that the man was prescribed AndroGel from November 2011 to February 14, 2014 to treat symptoms he attributed to low testosterone based on AndroGel advertisements and that AbbVie Inc., which manufactures AndroGel, wrongly marketed the low testosterone treatment therapy as having few side effects and is a safe method of alleviating symptoms associated with aging. According to the complaint, the Georgia man now has an increased risk of having additional cardiovascular disease, cerebrovascular accidents, and death as a result of his heart attacks allegedly due to taking AndroGel. (Case No: 1:14-cv-01726)
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