Call Today for a FREE Confidential Case Review
Toll-Free 24/7 (866) 920-0753

FDA Adds Heart Attack, Stroke Warnings to Testosterone

March 4, 2015 — The FDA is asking manufacturers of prescription testosterone replacement products to stop marketing them for the treatment of age-related “Low T,” add warnings about heart attacks and strokes, and start studying the long-term risks.

In a Safety Communication issued yesterday, the agency warned:

“Testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

It is normal for men over 50 to have lower testosterone levels than young, healthy men. It is also normal for older men to occasionally have fatigue, low sex drive, moodiness, increased body fat, less muscle mass, and other ailments.

The most popular testosterone products, such as AndroGel, were marketed with a ubiquitous ad campaign suggesting that these ailments could be symptoms of “Low T,” encouraging men to talk to their doctor. Between 2009 and 2013, prescriptions for testosterone skyrocketed from 1.3 million to 2.3 million.

Federal law prohibits marketing drugs for “off-label” (unapproved) purposes. However, only 50% of men on testosterone therapy actually have hypogonadism, which is the only condition the FDA has approved the drugs to treat.

Hypogonadism involves low testosterone due to a medical condition, such as missing testicles, pituitary gland problems, chemotherapy side effects, infections, and more.

One major reason “off-label” marketing is prohibited is because long-term side effects have not been studied. Now, the FDA is demanding that drug-makers conduct new clinical trials to assess potential cardiovascular side effects of testosterone therapy.

At least two studies have already found evidence of a risk. One study (Vigen) found a 30% higher risk of heart attack, stroke, and death. Another study (Finkle) found higher rates of heart attack in the 90 days after an initial prescription for testosterone.

Do I have a Testosterone Therapy Lawsuit?

The Schmidt Firm, PLLC is currently accepting testosterone induced injury cases in all 50 states. If you or somebody you know has been injured by a heart attack, stroke, or death, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

Free Case Evaluation

The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.

No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.