FDA Requires Updates to "Low-T" Product Warning Labels
You may have spotted these commercials while watching the football game, your favorite show, or the evening news.
Over the last years, “Low T” advertisements have flooded television networks, warning viewers of the dangers of low testosterone and touting their testosterone therapy products as a solution. With the help of testosterone therapy, such advertisements claim, men can raise their sex drive, elevate their mood, and increase their muscle mass.
Sounds great, right? Unfortunately, not too long after Low-T products hit the shelves, this type of medication revealed itself to have severe, often fatal consequences, including increased risk of heart attack, stroke, and blood clotting.
This month, the US Food and Drug Administration (FDA) confirmed the risks of testosterone replacement therapy in a safety announcement, maintaining that “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”.
For this reason, the FDA is now requiring manufacturers of testosterone replacement therapy products to change their labels in order to clarify safe uses for these medications, and add information about the possible increased risk of heart attacks and strokes associated with these products.
The FDA goes on to warn health care professionals against prescribing Low-T products to patients unless they have certain medical conditions. They advise health care professionals to inform patients of the increased risk of heart attacks, stroke, and death when determining whether to start or continue testosterone therapy. The FDA is also requiring manufacturers of testosterone replacement therapy products to conduct a clinical trial that looks deeper into health risks.
Should I be Concerned?
As testosterone replacement therapies came under scrutiny over recent years, researchers discovered that many approved testosterone replacement medications could have harmful, sometimes fatal, side effects. Some of the most popular Low-T medications with potentially adverse side effects include:
- Androderm®
- AndroGel®
- Android®
- Axiron®
- Fortesta®
- Bio-T-Gel®
- Delaestryl®
- Depo-Testosterone®
- DHEA®
- Methyltestosterone®
- Striant®
- Testofen®
- Testopel®
- Testosterone Cypionate®
- Testred®
These are just a handful of the many past and current low-testosterone products. If you have used one of these or any other low testosterone therapy products, you should seek medical attention if you exhibit any one of the following symptoms:
- Aggressive behavior
- Headache
- Hypertension
- Chest pain
- Shortness of breath or difficulty breathing
- Weakness in one side of the body
- Slurred speech or difficulty speaking
- Prostate enlargement
- Difficulty urinating
These symptoms may be indicative of larger problems, including heart attack, stroke, prostate cancer, and liver cancer.
In addition, testosterone therapy treatments can be particularly harmful to women and children. Women and children who come into skin contact with testosterone medications may absorb some of the medication, which can result in adverse effects such as deepened voice, reproductive anomalies, and stunted growth.
Manufacturers should be held accountable for the harm their products cause to their consumers if they fail to properly warn of risks and side effects. If you or someone you love has suffered harmful, fatal, or otherwise undesirable side effects after using testosterone replacement medications, contact a personal injury lawyer with experience in prescription drug liability cases. An attorney can help you recover damages for your suffering, and help raise awareness of the deceptive and damaging practices of testosterone manufacturing companies.
About the Author:
Since 1994, seasoned litigation and trial lawyer Anthony B. White has helped thousands of accident victims seek damages due to injuries sustained as a result of another party’s negligence. Included in America’s Registry of Outstanding Professionals and selected to the 2012, 2013, and 2014 editions of Florida Super Lawyers, Mr. White specializes in car accidents, insurance disputes, wrongful death, product liability, and medical malpractice cases. He is a longstanding member of the Florida Justice Association and the American Association for Justice and currently sits on the Board of Directors of the Broward County Justice Association.