FDA Panel Advises Testosterone Therapy for “Low T” Needs Further Investigation
When the Food and Drug Administration originally approved some types of testosterone therapy, the intended use was to treat serious hormonal disorders, such as hypogonadism.
Despite this limited approval, pharmaceutical companies heavily marketed the claim that testosterone products could treat “symptoms of Low T,” a series of age-related changes in men that may be related to a decline in testosterone production. These symptoms typically include exhaustion and low sex drive.
In response to this, an FDA panel met to discuss further use of testosterone therapy to treat this non-life-threatening condition, and the FDA advises Testosterone Therapy pharmaceutical companies like AbbVie and Eli Lilly must conduct further studies into the effectiveness of testosterone therapy on “Low T.”
Several men and their families have filed personal injury lawsuits against testosterone therapy manufacturers in recent years, because the treatment can allegedly lead to heart conditions, stroke, and blood clots in older men. Some independent studies have backed up the potential life-threatening side effects of unnecessary testosterone therapy.
In a 20-1 panel vote, The FDA advises Testosterone Therapy drug developers further investigate the potential cardiovascular risks of their testosterone products ; in a second vote, also 20-1, the FDA advisory panel ruled it would revise who may be prescribed the drugs.
“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.
Eli Lilly stated that, so far, no causal link between testosterone therapy and cardiovascular problems could be determined conclusively, but the company released its own statement: “However, based on feedback from the committees, Lilly will collaborate with the FDA to determine how to communicate cardiovascular risk to patients.”
Two weeks before the panel met, FDA reviewers stated 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 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.”
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 Lawsuit
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