Low testosterone can produce a variety of difficulties for men including low motivation, low energy, and limited sex drive. Testosterone replacement products are often prescribed to men who have low testosterone levels. Unfortunately, the risk associated with testosterone replacement products is not fully understood. In fact, there is growing concern that some of these products may have negative side-effects such as cardiac arrest and stroke.
Medical experts note that normal testosterone levels in men can vary from about 300 to 900 nanograms per deciliter (ng/dL). Low testosterone has been linked to a variety of difficulties, especially sexual ones. More importantly, however, doctors believe that low testosterone may also be linked to other health problems such as high blood pressure, diabetes, metabolic syndrome, and obesity. Medical doctors and research studies agree that low testosterone can negatively impact a man. What they do not agree on, however, is whether treating the low testosterone, which can increase lean muscle mass, improve sexual performance, and increase bone density is worth the risk.
Although studies funded by pharmaceutical companies have concluded there is no increased risk of adverse cardiovascular events associated with testosterone drugs such as AndroGel, other research indicates that some Low T treatments may increase the risk of heart attack or stroke. Recently, however, the Food and Drug Administration (FDA) has demanded new warning labels and changes to existing labels for all prescription “Low T” drugs, such as AndroGel, Axiron, Testim, Depo-Testosterone, creams, patches and injections. The FDA said these additional warning labels are needed because the “FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use.” The FDA believes that some men may have an increased risk of heart attack, stroke, or death associated with the use of testosterone treatment.
AbbVie Inc. was established in 2013 as a spinoff from Abbott Laboratories. They currently employ an estimated 25,000 employees worldwide and reported revenue close to 20 billion in 2013. Although several different companies produce low testosterone products, AbbVie Inc. produces one of the most popular products called AndroGel, which is a testosterone replacement therapy drug which has recently come under fire due to reports that it may contribute to an increase in heart attacks in men. Sells for the controversial drug AndroGel have sky-rocketed over the last few years as the manufacturer promoted it as a viable treatment for Low T. In fact, the company reports they spent close to $80 million to promote the product and were able to corner an estimated 60 percent of the Low T treatment market.
No one is surprised that men have rushed to purchase AndroGel with promises from the company that it could combat common symptoms of aging such as low libido and fatigue, with what some are calling untested claims. Experts expect the sale of the drug to lower substantially this year and next as AbbVie battles against accusations that it failed to warn the public about AndroGel’s heart risks for men. Right now lawsuits have been filed which suggest AbbVie withheld information about the drug’s dangers and that the company deceived users by “relaying positive information through the press, including testimonials from retired professional athletes, while downplaying known adverse and serious health risks.” Legal experts expect more lawsuits against AbbVie to be filed. The FDA has also announced they are going to study therapy replacement products again given the new information they have received from users regarding the potential increase in the risk of heart attack, stroke, and prostate cancer.
Lawsuits are currently pending by more than 1,340 men who tried testosterone supplementation to treat their Low T and believe they suffered injury as a result. The lawsuits have been consolidated in the U.S. District Court in the Northern District of Illinois against seven companies involved in the marketing of the hormone. Discovery is set to start early spring of 2015. To be discussed is whether or not the men involved in the suit have suffered injuries, such as heart attacks, strokes, or other health problems after taking testosterone. The case is scheduled to be heard in 2016.
At issue is whether pharmaceutical companies overstepped the legal boundaries of marketing their products for a condition the FDA hasn’t even recognized as a disease. Attorneys for the plaintiffs argue that companies engaged in “disease mongering” to convince men they had a condition that may not have been real. Right now the FDA only approves testosterone for treatment of hypogonadism, a drastic hormonal decline caused by injury or disease. Other “off label” marketing, attorneys argue, should not be allowed. If you have been injured from the direct-to-consumer ads which attributed low testosterone to symptoms associated with aging, including low motivation, low libido and fatigue, you may be able to receive compensation for your injuries. Additionally, the FDA now requires companies who sell low testosterone products to improve their labeling and warnings for patients.