The United States Food and Drug Administration (FDA) has finally begun to push back against the trend of overprescribing testosterone treatments, and recently released new marketing rules for low-t drugs.

Due to these new rules, pharmaceutical manufacturers released new instructions for medical prescribers, highlighting the fact that testosterone is not an approved treatment for “low-t.” The companies now must warn doctors about an increased risk of heart attack and stroke for men who take testosterone replacement therapy.

Concerns Over Low-T Marketing

Many medical professionals believe that the prevalence low testosterone or “low-t” condition is the result of pharmaceutical companies advertising strategies. Prescriptions for testosterone treatments began to exponentially increase in 2007, when Abbott Laboratories launched an awareness campaign called “Is it Low-T?”

The campaign focused on middle aged men and promised them they would feel thinner, more muscular, more energetic, and more sexually satisfied. The low-t campaign told consumers to request testosterone treatments from their medical professionals if they had gained weight, felt sad or grumpy at times, or became sleepy after meals. These are all symptoms that naturally occur as men (and women) grow older and age.

According to researchers, campaigns like the low-t campaign generally blur the lines between increased awareness about important public health issues and infomercials intended to sell medications. The marketing scheme is simple: the more low-t diagnoses medical professionals make, the more testosterone prescriptions will be written and sold.

Unfortunately, the low-t marketing campaign is not targeting the right men. Low testosterone levels can lead to serious side effects in certain cases. Men experiencing abnormally low testosterone levels may have experienced trauma, chemotherapy, genetic abnormalities, undescended testes, or other serious underlying medical issues. These men need testosterone treatments in order to function and develop normally.

Many medical professionals believe that these men don’t need awareness campaigns because their treatment is standard practice.

FDA Questions Testosterone Therapy Benefits

The FDA is skeptical about the benefits of treating low-t in most men. In fact, the FDA’s endocrine advisory committee has begun to question whether low-T is even a disease or merely the natural affects of aging.

Several medical researchers, including Steven Woloshin and Lisa Schwartz, question why the FDA has been so slow to react to the low-t campaign. According to statistics, over the last 7 years at least 25 million prescriptions for low-t have been written. As a result, the drug manufacturers of low-t treatments have made over $9.7 billion in sales.

The FDA claims that it can take limited action in marketing materials that do not address a specific drug by name (like the majority of low-t ads). However, the agency can regulate campaigns that become uniquely identified with a specific unnamed drug. The low-t campaign identifies testosterone treatments in all of its available forms which include, tablet, patch, roll-on, and gels.

Testosterone product lawsuits are generally filed by men who used the treatments and suffered adverse side effects. According to the Journal of the American Medical Association, men who took testosterone replacement therapy drugs increased their risk of having a heart attack or stroke by 30%.

Product liability attorneys are currently looking for potential plaintiffs to bring testosterone product lawsuits against drug companies like Abbott Laboratories.