FDA Fails to Find Evidence That Use of Testosterone Therapy Works
The Food and Drug Administration has scheduled a meeting amongst regulators to discuss the benefits and detriments of the use of testosterone therapy, in light of numerous Low T personal injury lawsuits that have recently alleged harmful side effects from using the product, including blood clots, strokes, and heart problems.
Two weeks before the official meeting, however, the FDA announced that evidence shows there is little benefit to patients use of testosterone therapy, whether gels or pills.
FDA reviewers state that “the need to replace testosterone in these older men remains debatable,” according to the statement from the federal agency. Currently, the FDA has approved only a few types of testosterone therapy, and only for extreme cases of low testosterone in men such as hypogonadism. Despite this limited approval, use of testosterone therapy has expanded for male patients over the age of 40 to treat typical signs of aging such as low energy, low sex drive, and loss of muscle.
The FDA memo states that testosterone therapy prescriptions for these patients is “controversial” and notes that “there are no reliable data on the benefit in such a population.”
However, the FDA also added that other studies into the dangers of use of testosterone therapy were unconvincing. The current available studies that look at the risks of heart disease and stroke in older testosterone therapy patients “do not provide convincing evidence that testosterone replacement therapy is associated with adverse cardiovascular events.”
The FDA advisory panel noted the “relative absence of large, controlled long-term studies, which makes it difficult to interpret the long-term clinical impact” of the treatments.
“Nevertheless,” the memo continued, “the data consistently support testosterone replacement therapy benefits on measures of lean mass, fat mass, and bone mineral density and architecture. Less consistently, data also suggest benefit with sexual function. Additionally, there is some evidence that suggests benefit with mood and fatigue.”
Meanwhile, all testosterone therapy personal injury lawsuits were recently consolidated into a multidistrict litigation (MDL). The testosterone therapy lawsuits were consolidated in the Northern District of Illinois under the Honorable Matthew F. Kennelly. The MDL was created on June 6th, and gathers “45 actions pending in four districts.”
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 Can Help with Testosterone Therapy Personal Injury Lawsuits
The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, from AndroGel to Zoloft. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as testosterone therapy or supplements, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800