Testosterone Replacement Therapy and Heart Attacks
By Rick Collins, Esq.
Q: Will testosterone replacement therapy increase my risk of a heart attack?
A: After a 2014 public safety alert that the U.S. Food and Drug Administration (FDA) was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products,”1 the agency changed testosterone labeling requirements in March 2015 to include a warning of possible increased cardiovascular (CV) risks. The FDA’s warnings likely scared the bejesus out of doctors and patients alike. But was FDA right about testosterone replacement therapy (TRT) and CV risks in light of more recent findings?
In January 2018, a comprehensive literature review was published in Sexual Medicine Reviews, concluding that TRT within the physiologic range for men with low testosterone “is a safe and effective therapeutic modality and imparts great benefits on men’s health and quality of life.”2 The author looked carefully at TRT and CV risks and found problems, noting that some studies purporting to associate TRT with CV risks were flawed due to contaminated data or non-validated statistical methods, while others weren’t designed to investigate CV risk or compared two groups that had nothing in common. The author concluded that “the purported risks of [TRT] with regard to [CV disease] are not supported by scientific or clinical evidence” and that the research suggests that TRT might be cardioprotective because low testosterone (hypogonadism) is a CV risk factor.
A 2018 article in Clinical Endocrinology reviewed “The state of testosterone therapy since the FDA’s 2015 labeling changes: Indications and cardiovascular risk.”3The authors’ goal was to “review these changes in the light of subsequently published studies.” They looked at 23 studies all published since FDA’s warnings. Were the new studies worrisome? Nope. Several large observational studies reported reduced CV events with TRT. Men whose blood levels of testosterone were brought into the normal range had lower risks of heart attacks than men with low testosterone levels. The overall conclusions were a sharp rebuke to FDA’s claims, finding that “existing evidence fails to support increased CV risk with [TRT]; on the contrary, there is evidence suggestive of real-world CV benefits.”
So where does this leave us? Previous editions of this column have looked at the research on CV safety with TRT and found that the negative studies were very unpersuasive. That position has only been reinforced by subsequent research, which casts doubt on the claims of those plaintiff class action lawyers who, after FDA’s warnings, filed numerous lawsuits on behalf of men who alleged they suffered CV injuries, including heart attack, stroke, deep vein thrombosis, and pulmonary embolism, as a result of TRT. More than 7,700 cases were filed, with the majority against AbbVie Inc. and Abbott Laboratories, mostly for injuries allegedly caused by their TRT drug AndroGel®4.While many cases are still pending litigation, certain companies have chosen to settle prior to trial. In December 2017, Eli Lilly and Co. settled approximately 400 cases related to its TRT drug Axiron® and in January 2018, Endo’s Auxilium Pharmaceuticals settled a case related to its TRT drug Testim®.5 For those cases still awaiting trial, the new studies give defense lawyers for the drug companies more evidence than ever to support their side.
Now, a few words of caution. It’s said that the difference between a medicine and a poison is the dose. So, while medically bringing your low testosterone levels into the normal range may be safe and greatly beneficial (let’s say, with 100 to 200 mg of a prescribed testosterone ester per week), taking 10 times that dose using black-market steroids, along with a cornucopia of other anabolics and ancillaries, especially for extended periods and without medical supervision or monitoring, will almost certainly NOT be good for your heart. The new research only examines and supports the benefits of supervised, medically prescribed TRT to bring hypogonadal men into the healthy normal range. In sum, while some hypogonadal men may not be good candidates for TRT, the body of evidence, including the new studies, shows that TRT is quite good for the hearts of most hypogonadal men.
Rick Collins, Esq., CSCS [https://rickcollins.com/] is the lawyer who members of the bodybuilding community and dietary supplement industry turn to when they need legal help or representation. [© Rick Collins, 2021. All rights reserved. For informational purposes only, not to be construed as legal or medical advice.]
References:
1. https://www.fda.gov/media/88140/download
2. https://www.sciencedirect.com/science/article/pii/S2050052117301191
3. https://pubmed.ncbi.nlm.nih.gov/29486065/
4. https://www.consumersafety.org/drug-lawsuits/testosterone/
5. https://www.drugwatch.com/testosterone/lawsuits/
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