Testosterone Therapy (Low-T) Drug Investigation
UPDATE – FDA ISSUES DRUG SAFTETY COMMUNICATION AND LABELING CHANGE FOR LOW-T PRODUCTS
The FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. 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.
Stueve Siegel Hanson is investigating claims of cardiovascular complications tied to prescription testosterone (Low-T) supplements. New research indicates testosterone therapy for men could cause an increased risk of heart attack and stroke, even death.
Low-T supplements include the following: Androderm, Androgel, Axiron, Bio-T-Gel, Delatestryl, Depo Testosterone, Fortesta, Striant, Testim, Testopel. These FDA-approved products are applied through topical gel, transdermal patch, buccal system (gum), and/or injection.
In January 2014, the U.S. Food and Drug Administration (FDA) released a statement that warned of the potential risks of testosterone therapy and announced they will be conducting further research. The safety announcement in part, says,
“The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.”
The FDA made the statement after reviewing study results published by the National Cancer Institute and the Journal of the American Medical Association (JAMA). The National Cancer Institute researchers report that within 90 days, taking the hormone can more than double heart attack risk in men ages 65 and up – as well as nearly triple risk in younger men with known heart disease. The study published by JAMA had similar results, finding that older men has a nearly 30% increase in stroke, heart attack and death when undergoing testosterone therapy.
What is Low-T?
Testosterone is a hormone that acts as the primary sex hormone in men. It promotes:
- Bone density
- Fat distribution
- Muscle strength and mass
- Red blood cell production
- Sex drive
- Sperm production
Testosterone peaks during adolescence and early adulthood. As men age, testosterone level gradually declines. Lower testosterone level (Low-T) symptoms can include changes in sexual function, changes in sleep patterns, physical changes (such as increased body fat and reduced muscle bulk) and emotional changes.
FDA Approval is Limited
The FDA has not approved any of the testosterone products for men with low testosterone who do not have an associated medical condition. These conditions may include a failure of testicles to produce testosterone for a variety of reasons or brain structure problems.
Marketing of Low-T Drugs
Drug manufacturers have been aggressively marketing testosterone replacement therapy to men who complain of being overweight, tired, and less interested in sex. These advertisements suggest the men could be suffering from Low-T and urge them to visit their doctor for a prescription for testosterone replacement drugs.
The marketing has worked. Use of testosterone drugs has increased fivefold from 2000 to 2011, with 5.3 million prescriptions filled in 2011 and sales expected to hit $5 billion by 2017. However, research has suggested that most of these prescriptions are not medically needed. Many patients never even had their testosterone levels checked before beginning the therapy.
If you or someone you know has experienced cardiovascular side effects due to Low-T therapy, including heart attack and stroke, and wish to receive additional information about your legal options, please call 1.888.756.6494.