Another Warning from the FDA Chides Doctors for Over-Prescribing and Enabling Overuse of Testosterone Therapy
The Food and Drug Administration has issued another warning to doctors regarding overuse of testosterone replacement therapy – the gels, pills, and ointments, the agency says, should not be overused to treat common signs of aging, such as low libido and exhaustion.
Although many doctors have, for years, prescribed various forms of testosterone therapy to men to treat “Low T” and other signs of aging, the treatments have never officially been approved by the FDA to treat low libido, tiredness, or aging signs. Regardless, pharmaceutical companies have inundated the market with advertisements targeted towards aging men, over-prescribed, and enabled overuse of testosterone therapy.
Testosterone therapy has, so far, only been approved to treat diagnosed low testosterone diseases, caused by injury, cancer, or genetic diseases like hypogonadism. Any other use is outside of current government recommendations, the FDA said, and added that testosterone therapy can increase the risk of heart attack, stroke, and other cardiovascular problems. In spite of reported dangers, as many as half of the patients prescribed some form of testosterone therapy have not been tested for “low T.”
“The benefits and safety of this use have not been established,” the FDA said in a statement Tuesday, March 3rd. In September last year, the FDA convened a panel to discuss the potential benefits and side effects of testosterone therapy, and advised pharmaceutical companies like AbbVie and Eli Lilly that they must conduct more thorough studies on their testosterone therapy products to ensure the drugs’ safety, and its effectiveness on aging symptoms, not just hormonal disorders.
Several plaintiffs have filed lawsuits against major pharmaceutical companies that manufacture testosterone therapy, especially AbbVie, which manufactures Androgel. AbbVie, however, defends its marketing of Androgel and other testosterone therapies to older men.
“Testosterone replacement therapy is an important men’s health topic. AbbVie is committed to our patients and we will work with the FDA during its review,” the pharmaceutical company said in a statement last fall.
The FDA’s memo from September stated that testosterone therapy prescriptions for these patients is “controversial” and notes that “there are no reliable data on the benefit in such a population.”
Testosterone therapy defendants include AbbVie Inc. and Abbott Laboratories, Inc. (Androgel), Lilly USA LLC and Eli Lilly and Co. (Axiron), and Endo Pharmaceuticals (Aveed, Fortesta, and Delatestryl), who all supported the creation of an MDL. Actavis and Auxilium were against the “creation of an all-testosterone therapy MDL.” Pfizer Inc. and Pharmacia & Upjohn Co. wanted an MDL specifically for testosterone gel products.
The Strom Law Firm Defends Victims of Testosterone Therapy Side Effects
The South Carolina personal injury attorneys at the Strom Law Firm are investigating cases involving the dangerous side effects of testosterone therapy, especially from Androgel, Axiron, and Testin. Testosterone therapy lawsuits allege that the manfacturers failed to warn consumers of the risks, instead directly targeting potential users with heavy direct mail marketing. Men over the age of 65 are at greater risk of developing blood clots or cardiovascular problems if they use testosterone therapy to treat “low T.”
If you or a loved one were prescribed testosterone therapy, and you suffered serious and potentially life threatening side effects including heart attack, stroke, or death, our South Carolina testosterone therapy attorneys are here to help. Contact us today for a free consultation. 803.252.4800