A panel of drug experts on Wednesday voted 20-1 in favor of the Food and Drug Administration imposing more stringent guidelines restricting the prescription and sale of testosterone products to men who are only experiencing symptoms of aging (such as decreased energy and libido) and not true low-testosterone related problems. Since the FDA is prone to take the advice of similar expert panels, even though they are not obligated to do so, it is likely that this could mean a big economic hit to the multi-billion dollar testosterone drug industry.

Today, over two million men in the U.S. regularly use testosterone drug products, whether in the form of a testosterone gel, cream, or shot. The majority of these male consumers do not have a serious medical condition requiring a low-t treatment, but were allegedly convinced to ask their doctors for a testosterone prescription due to aggressive and often misleading low-T product commercials and marketing.

These marketing tactics have been thrust in the spotlight lately after a recent study found that men who take testosterone increased their risk of heart attack, stroke, and death by nearly 30%. This study sparked a flurry of testosterone injury lawsuits by men who say they were injured by low-t creams, gels, injections and patches.

Should the FDA limit testosterone prescriptions in the U.S. the marketing for such products would be seriously monitored and insurance coverage guidelines for low-T treatments would become quite limited.

According to Dr. Michael Domanski, one of 20 doctors on the FDA advisory panel and director of heart failure research at Mount Sinai School of Medicine, “The whole idea [of limiting testosterone products] is to try to rein in the inappropriate advertising and use of these drugs[.]”

In doing so, men who do not have a true low-t condition and are at risk of heart problems would not be able to have these products as easily prescribed, as various heart conditions have been reported as possible testosterone side effects.

FDA Examines Testosterone Heart Risks

Currently, the FDA is conducting research into the various reported cases of stroke and heart attack in testosterone product consumers to evaluate the safety of these products and whether or not they outweigh the benefits for those with a true low-t condition.

As for those men experiencing decreased energy and libido and loss of muscle mass who have turned to testosterone gels and creams as a quick fix, the FDA has publicly stated, “the benefits of testosterone treatments for healthy, aging men are unproven, and that the drugs could be risky. Men who take them have been found to have higher rates of heart problems in some studies,” according to a recent NY Times article.

With this support from a panel of experts and the FDA, more consumers may pursue testosterone product lawsuits or join testosterone drug class action lawsuits.

Testosterone Side Effects

The various testosterone gels, creams, shots, and packages on the drug market are heavily advertised to middle age men experiencing the natural effects of aging, including a natural decrease in testosterone production. Many testosterone product manufacturer’s like AbbVie Inc. market their products with alleged promises of increased libido, energy and muscle conditioning without fully informing their customers of possible, serious side effects.

Some serious testosterone side effects include:

• Blood clots
• Enlarged prostrate
• Heart attack
• Stroke
• Death

There have been recent studies reporting that spouses and children of testosterone product consumers allegedly having secondary exposure to the testosterone hormones. According to the FDA Drug Safety and Availability site:

“The manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, were required to include a boxed warning on the products’ labels. The agency required this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).”

Additionally, studies have shown that secondary testosterone exposure can cause physical changes in women  and potentially result in fetal damage in pregnant women.

As a result many individuals and family members are pursuing testosterone injury lawsuits against the manufacturers of these products.