New Medical Research Suggests The Safety Of A Testosterone Drug Might Depend On Its Form: Injections / Shots; Creams / Gels; Skin Patches
On March 3, 2015 an FDA Drug Safety Communication about testosterone products was issued requiring drug companies to make a “labeling change to inform of possible increased risk of heart attack and stroke with use”.
Now, according to a large retrospective cohort medical study published online by the JAMA Internal Medicine journal in May 2015, we learn that short-acting testosterone injections or shots -- such as the Depo-Testosterone (testosterone cypionate) injection from Pharmacia and Upjohn Company (a division of Pfizer) -- are associated with a higher risk of cardiovascular events, hospitalizations, and deaths when compared with gels or patches.
From the Abstract for "Comparative Safety of Testosterone Dosage Forms" (an Online First article), we get this overview of the new medical research:
Importance Increases in testosterone use and mixed reports of adverse events have raised concerns about the cardiovascular safety of testosterone. Testosterone is available in several delivery mechanisms with varying pharmacokinetics; injections cause spikes in testosterone levels, and transdermal patches and gels cause more subtle but sustained increases. The comparative cardiovascular safety of gels, injections, and patches has not been studied.
Objective To determine the comparative cardiovascular safety of testosterone injections, patches, and gels.
Conclusions and Relevance Testosterone injections were associated with a greater risk of cardiovascular events, hospitalizations, and deaths compared with gels. Patches and gels had similar risk profiles. However, this study did not assess whether patients met criteria for use of testosterone and did not assess the safety of testosterone among users compared with nonusers of the drug.
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From a May 11, 2015 news report, "Testosterone Shots: Riskier Than Gels or Patches?" -- with this sub-headline: "Spike in T levels from bolus injections may explain higher adverse outcome rates" -- published online by MedPage Today, we get the following summary information and commentary about this testosterone drugs safety study:
Compared with men using gels, those receiving injections had a greater risk for the composite of cardiovascular outcomes (MI, unstable angina, and stroke) (HR 1.26, 95% CI 1.18-1.35), hospitalization (HR 1.16, 95% CI 1.13-1.19), and death (HR 1.34, 95% CI 1.15-1.56) but not VTE (HR 0.92, 95% CI 0.76-1.11).
When testosterone patches were compared with gels, the investigator did not find any increased risk for cardiovascular events (HR 1.10, 95% CI 0.94-1.29), hospitalization (HR 1.04, 95% CI 1.00-1.08), death (HR 1.02, 95% CI 0.77-1.33), or VTE (HR 1.08, 95% CI 0.79-1.47).
"Different dosage forms lead to different serum testosterone levels over time -- injections result in spikes and super-normal levels -- possibly accounting for the observed risk of cardiovascular disease," [J. Bradley Layton, PhD, an epidemiologist at the University of North Carolina Chapel Hill] and colleagues wrote....
The study is well-designed and done by a reputable group, said Bradley Anawalt, MD, an endocrinologist and professor of medicine at the University of Washington Medical Center, in an email to MedPage Today. But it only included short-acting forms of injectable testosterone (testosterone cypionate, enanthate, and propionate) and not the longer-acting testosterone undecanoate which is the most common form used in Europe and which was recently approved in the U.S.
The short-acting forms of injectable testosterone are associated with higher spikes in testosterone levels, said Anawalt, who was not involved with the study.
"I don't think we should change our practice based on this study," Anawalt said. However, he added that for those using short-acting testosterone injections, the study suggests it may be prudent to use lower doses at more frequent intervals.
For more about what is currently know about testosterone drugs like Axiron, AndroGel, Testim, Depo-Testosterone, see this website page Testosterone Therapy Drugs.
We will continue to watch for new medical research about testosterone drugs safety especially as regards heart attacks or myocardial infarction (MI), strokes, and cardiovascular deaths which might be caused by so-called "Low-T" testosterone therapy products such as Depo-Testosterone injections or shots.