A testosterone lawsuit has been filed in Canada against the manufacturer of the testosterone injectable, Delatestryl (Testosterone Enanthate), over allegations that include that the consumers were not sufficiently advised of the risks associated with the so-called “Low T” medication. The lawsuit also alleges that use of Low T treatment is tied to the increased likelihood of cardiovascular reactions, such as heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism, and death.
The U.S. Food and Drug Administration (FDA) posted a notice on its website indicating that, on September 17, 2014, it would be convening a joint meeting with the Reproductive and Urologic Drugs Advisory and the Drug Safety and Risk Management Advisory committees. Recommendations regarding cardiac reactions tied to Low T drugs and what issues should be considered when prescribing low testosterone therapy are expected to be among the covered topics.
Low-T drugs have long been tied to a number of significant side effects, including pulmonary embolism, DVT, stroke, heart attack and other cardiovascular issues, and death. In fact, since an FDA Safety Announcement concerning testosterone medications was announced in January 2014, four AndroGel lawsuits were filed in U.S. District Court, Northern District of Illinois. All of the lawsuits similarly allege that use of AndroGel caused the men, all of who allege no prior history of cardiac disease, to suffer heart attacks, heart failure, and stroke.
Court documents reveal that over 150 testosterone lawsuits have been filed on behalf of U.S. consumers in the multidistrict litigation (MDL) underway in U.S. District Court, Northern District of Illinois. Similar to the complaint filed in Canada, the cases allege that the makers of low testosterone treatments have neglected to warn physicians and patients about the medications’ potential to lead to serious heart problems.
The agency review followed release of two studies that found that older men and men with pre-existing cardiac disease were likelier to suffer heart attack, stroke, or death if taking testosterone medication. The first of the two studies was published in the Journal of the American Medical Association (JAMA) last November, and involved older men. The research suggested increased risks for stroke, heart attack, and death were seen in men prescribed testosterone therapy. The second study, published in journal, PLoS, also suggested increased risks for heart attack in older men, and in younger men diagnosed with a pre-existing heart disease.
Current testosterone treatments include skin patches; short-acting injections; topical gels; and the buccal system, which involves application to the upper gum or inner cheek. Products include AbbVie Inc’s AndroGel, Androderm, Axiron, Bio-T-Gel, and Delatestryl. Endo International, previously known as Endo Health Solutions Inc., announced launch of Aveed, Reuters reported.