There has been much controversy lately surrounding testosterone replacement therapies and their harmful effects on men’s cardiovascular health. Despite several reputable studies linking T-Therapy drugs with increased risk of heart attack, stroke and cardiac death, the FDA refuses to add such warnings to drug labels. Testosterone replacement therapy attorneys at Pintas & Mullins Law Firm take a deeper look into this issue and who is most at risk.
Testosterone therapy was approved by the FDA only for use in men with dangerously low testosterone levels (hypogonadism) in addition to another underlying health condition, such as limited mobility. The drugs, which come as either injections or topical gels in the United States, were not approved for men who exhibit natural signs of age-related testosterone decline.
Despite these clear indications, T-Therapy manufacturers such as AbbVie have been aggressively, some say fraudulently marketing the drugs. Their ads usually come on during sports games or other male-oriented programs, depicting a middle-aged man with “low T,” who then asks his doctor about Androgel and ultimately drives off into the sunset with a 20-something babe. Granted, some men (about 2% of the male population) do suffer from dangerously-low testosterone levels to the point that it becomes a medical problem.
For the vast majority of men, however, symptoms like fatigue, decreased muscle mass and strength, and changes in libido are simply the common, natural signs of aging, and not cause for concern. It is not surprising that American men are still choosing to take T-Therapy drugs to combat their fearful gray hairs. What is surprising is how little patients are being told about the risks of this therapy.
Two recently-published studies have made headlines in major news outlets. The first study, titled the Testosterone in Older Men with Mobility Limitations (TOM) trial, enrolled about 200 male patients, all over the age of 65 and all with evidence of limited physical function. Researchers split the patients into two groups, the first receiving a topical T-Therapy gel (like Androgel) and the second receiving a placebo.
After it became clear that the patients prescribed to the T-Therapy were suffering serious cardiac events in high rates (more than double than those on the placebo), the researchers shut down the trial. Similar conclusions were reached in the second, larger trial. This larger study included over 55,000 male patients of varying ages. Researchers tracked their health records in the year prior to starting T-Therapy, and followed them through the three months after they began using the medication.
Researchers in this study found that men 65 and older taking T-Therapy drugs had double the chance of suffering a heart attack than the general population. Additionally, younger men with preexisting heart disease also had a two- to three-fold higher risk of heart attack.
Dramatic Increase in Prescriptions Despite Lack of Testing
What is perhaps most concerning about these findings is the lack of initial
testing before doctors write prescriptions. Over the past decade the number
of T-Therapy prescriptions written has increased three fold, however,
at least 25% of those patients were never given initial blood tests to
determine their baseline testosterone levels. This is significant because
of the conflicting evidence of the short and long term risks of T-Therapy,
particularly concerning the risks of cardiovascular disease and prostate
cancer, two incredibly serious conditions.
If young, healthy men are being prescribed T-Therapies without evidence that such treatment is needed in the first place, there is significant risk that these patients are being unnecessarily subjected to a host of potentially-fatal ailments. Physicians need to tell patients of these risks, and fully disclose how much is not yet known about testosterone therapy. In some cases, it could mean the difference between life and death.
Our team of testosterone therapy attorneys is currently investigating cases of cardiovascular injury from Androgel and other similar medications. If you or someone you love was hospitalized after taking T-Therapy, contact our firm immediately. We can answer any questions you may have about filing a claim and obtaining compensation for your medical bills, lost wages, or loss of a loved one. Our case reviews are available to potential patients nationwide, free of charge.