The U.S. Food and Drug Administration (FDA) just announced its approval of Endo International Plc’s Aveed, a drug it previously rejected not once, but three times. Aveed is a testosterone replacement therapy that is approved to treat male hypogonadism.
Male hypogonadism is a condition in which the male body produces low levels of testosterone. Testosterone is the male hormone responsible for maintaining muscle bulk, sexual function, and bone growth. Low levels of testosterone may lead to reduced libido, fatigue, and depression, according to Reuters.
Aveed was rejected for the third time last May, according to Reuters. The FDA indicated that, at that time, Endo needed to provide an improved plan to manage risks associated with the long-acting testosterone treatment. Aveed contains both testosterone and castor oil and the agency was concerned about the risks of castor oil leading to pulmonary blood vessel blockages and complications associated with post-injection reactions.
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 that its Aveed will be launching early this month, Reuters reported.
Meanwhile, the FDA recently issued a “Drug Safety Communication” in which it announced its investigation of increased stroke, heart attack, and death risks in men taking currently FDA-approved testosterone products, such as Androgel. The agency also indicated that it is monitoring cardiac and death risks tied to testosterone products for approved uses and is re-assessing these risks following the publication of two separate research studies on the matter. Both studies suggest that an increased risk of cardiovascular events was seen in men prescribed and receiving testosterone therapy.
Public Citizen, a consumer advocacy group, has urged the FDA to increase the warnings about these risks on drugs’ labels, calling for the agency to add a “Black Box” warning, the FDA’s most serious warning, a prior Reuters report stated. According to the FDA, no approved testosterone product has been cleared for use in men diagnosed with low testosterone that is not linked to a medical condition. Medical conditions include the genetic failure of the testicles to produce testosterone, according to a previous Reuters report.
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.
Low-T drugs have been tied to a number of significant side effects, including pulmonary embolism, deep vein thrombosis (DVT), stroke, heart attack and other cardiovascular injuries, and death. In fact, since the FDA’s announcement, four AndroGel lawsuits were filed in U.S. District Court, Northern District of Illinois. All of the lawsuits similarly allege that the use of AndroGel caused the men, all of who allege no prior history of cardiac disease, to suffer heart attacks, heart failure and stroke.