FDA Updates Warning Label on Testosterone Products. The U.S. Food and Drug Administration (FDA) is updating the warning label on all prescription testosterone drugs to warn that these products may present a risk of abuse and dependence.
According to an Oct. 25, 2016 FDA Safety Communication, the Abuse and Dependence section is being revised to include information about abuse and dependence associated with testosterone and other anabolic androgenic steroids (AAS). The updated warning is based on published literature and case reports.
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The new label discloses that testosterone products present a risk of abuse and can lead to serious adverse events. People who become addicted to testosterone or abuse testosterone products have experienced negative heart and mental health side effects.
“In addition to the new Warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/AAS, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.” the alert states.
Testosterone and other AAS were categorized as Schedule III of the Controlled Substances Act following the Anabolic Steroids Control Act of 1990. According to the FDA Safety Communication, adults and adolescents sometimes abuse testosterone and other AAS. Testosterone abusers may include athletes and bodybuilders. The agency warns that taking high doses of testosterone can negatively affect the heart, brain, liver, mental health and endocrine system.
“Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.” the agency warns.
The FDA encourages healthcare professionals and patients to report side effects to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.
Testosterone Replacement Therapy Background
The FDA approved prescription testosterone drugs for individuals who have low levels of testosterone due to a medical condition. Patients with a medical need for testosterone replacement products may include individuals whose testicles do not produce the hormone due to a genetic abnormality, or damaged testicles from cancer treatment or infection. Testosterone replacement drugs are not approved to treat decreased levels of testosterone due to normal aging.
In March 2015, the FDA mandated a label change on testosterone products to warn about the risk of heart attack and stroke. The agency revised the label based on data from published studies and expert input from an Advisory Committee meeting. “These studies included aging men treated with testosterone.
Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.” the agency said in its safety alert. The FDA urged healthcare professionals to disclose the risk of heart attack and stroke to patients taking testosterone therapy.
The FDA said it ordered manufacturers of testosterone products to conduct clinical trials to study the cardiovascular risks associated with testosterone replacement therapy.
The agency emphasized that testosterone replacement products are only approved for low levels of testosterone due to a medical condition, and not low testosterone levels associated with aging. “The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.” FDA cautioned.
Regulators urged testosterone replacement patients to seek medication attention if they develop symptoms of a heart attack or stroke, which include:
- Chest pain
- Shortness of breath or difficulty breathing
- Weakness in one part or one side of the body
- Slurred speech
Lawsuits Filed over Testosterone Products, including Androgel
Parker Waichman comments that personal injury lawsuits have been filed over testosterone replacement products. Plaintiffs in the litigation allege that they suffered heart attack or stroke after taking the products. The manufacturers are accused of failing to warn about the risks while promoting the benefits testosterone products.
Specifically, plaintiffs point out, testosterone replacement drug makers describe symptoms of “Low-T”, including decreased sexual desire, erectile dysfunction, fatigue, decreased strength and osteoporosis. However, lawsuits allege that Low-T is not a true medical condition, and that manufacturers are simply listing signs of normal aging in order sell more products.
Lawsuits have been filed over Androgel, Testim, Axiron, Androderm and other testosterone replacement products. Federal lawsuits over Androgel were centralized into a multidistrict litigation (MDL) before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois. MDLs are created when many lawsuits share common allegations against the same defendant.
These group litigations help make the process more efficient. The first bellwether trial in the Androgel litigation against AbbVie is scheduled for June 2017. A bellwether trial is when the first lawsuit in a mass tort goes to court; the outcome can have important implications for the remaining cases.
The first Androgel bellwether trial involves a lawsuit filed on behalf of a man who started using the product in May 2010 treat hypogonadism. He suffered a heart attack in July 2010 at the age of 49, allegedly due to using Androgel. His lawsuit alleges that AbbVie failed to disclose the risk of heart attack, or myocardial infarction, to him or his physician.
Two bellwether trials in the Axiron litigation are slated to begin in January 2018 and March 2018.
The bellwether process has also been outlined for the Testim litigation, with the first trial slated to begin in November 2017.
According to court records, there are over 6,000 testosterone product liability lawsuits pending in federal court. In addition to heart attacks, lawsuits allege that testosterone drugs caused blood clots and blood clot-related conditions such as stroke.