Testosterone Prescriptions Draw New FDA Warnings About Dependence, Abuse

Amid continuing concerns about the heart risks with testosterone prescriptions, and efforts to limit use of the popular drugs to men who have a true medical need, federal regulators indicate that new warnings will be placed on Androgel, Testim, Axiron and other testosterone replacement therapy medications, indicating that users face a risk of addiction and abuse.

In an FDA warning statement issued on Tuesday, it was announced that a new class-wide labeling change will be made about the risk of abuse and dependence with testosterone drugs and other anabolic androgenic steroids.

“Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health and endocrine system,” the FDA warns. “Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility.”

The FDA also notes that testosterone drug abusers have reported suffering symptoms of withdrawal, including depression, fatigue, irritability, loss of appetite, decreased libido and insomnia.

The new warning will indicate that testosterone drugs have the potential for abuse which can result in serious adverse health events, highlighting the heart and mental health risks when used with steroids. It will also warn prescribers to test serum testosterone concentration levels if they suspect testosterone abuse.

Testosterone is a Schedule III controlled substance under the Anabolic Steroids Control Act of 1990. However, use of testosterone treatments among aging men has increased dramatically in recent years, amid aggressive marketing by drug makers, which encourage men to seek treatment if they experience symptoms of “low T”, such as reduced energy levels, strength, sex drive or other symptoms. However, the widespread use of medications and supplements have drawn criticism from some experts, which point out that there is no medical condition known as “low T”, which is a term that originated with drug marketing.

Testosterone replacement therapy, which includes blockbuster drugs like Androgel, Testim, Axiron and others, were initially expected to be a niche treatment for men suffering from testosterone deficiency caused by a medical condition, known as hypogonadism. However, as men receive prescription of the drugs for life-style reasons, the industry grew to generate more than $2 billion in sales annually in recent years.

Testosterone Litigation

The FDA warning comes as thousands of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone prescription lawsuits are moving forward in courts nationwide, indicating that users experienced a heart attack, stroke, blood clot or died while using the medications.

Last year, the FDA required new warnings about the potential risk of heart attacks and strokes from testosterone replacement therapy, urging doctors to only prescribe the drugs to men diagnosed with hypogonadism backed up by laboratory testing.

According to allegations raised in the testosterone prescription litigation, AbbVie and other pharmaceutical companies marketing the drugs withheld important safety warnings from consumers and the medical community, while promoting the widespread use of the medications among men without a true need for testosterone treatments.

Given the similar allegations raised in the lawsuits, more than 6,000 cases filed throughout the federal court system have been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

As part of the coordinated proceedings, a series of Androgel trials are expected to begin between April and November 2017, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

If testosterone injury settlements are not reached following bellwether trials in the MDL, the drug makers may face hundreds of individual trial dates in U.S. District Courts nationwide over failure to warn about the heart risks associated with their medications.