Testosterone Therapy and Heart Problems Linked Again in Recent Study

In the most recent study linking testosterone therapy to heart problems, researchers found a correlation between taking testosterone drugs and increased rates of heart attack both in men older than 65 and men younger than 65 with a known risk of heart problems.  The study, published on January 29, 2014, found that the risk for both groups was doubled in the 56,000 men that they tracked between 2008 and 2010.

A smaller scale randomized study, published in 2010 had also hinted at such a link; however, it studied only older men (over 65) using high doses of a testosterone gel and ended prematurely because of an increase in heart attacks, strokes, and other heart problems.  A Veterans Affairs study published in the Journal of the American Medical Association in November 2013 also found an almost 30 percent increase of heart attacks, strokes, and death in the 1,223 men who took the drug, vs. the 7,486 who did not.

Testosterone therapy heart problems

Some skeptics, such as Boston urologist Abraham Morgentaler (also an author of a book about testosterone) have argued that the studies were insufficient and neglect the heart problems that men with low testosterone have already.  Dr. Michael Lauer, director of cardiovascular sciences at the National Heart, Lung and Blood Institute concedes that because the study was not a randomized trial, “[b]y itself… … it may not tell us very much.”  However, with the other studies, he continues, it “tells us that we potentially have a problem.”

The studies have prompted some researchers, including William Finkle (the lead author of the recent study), to call for the FDA to revise warning labels specifically citing the link between testosterone therapy and increased heart problems.  According to Sidney Wolfe, currently senior advisor at Public Citizen, a public health advocacy group, “Given that there have been several studies now, I don’t see how the Food and Drug Administration can justify having no warnings of heart attacks at all.”

AndroGel and heart attack risks

The FDA has approved testosterone therapy only for men with hypogonadism, a condition in which the male sex organs produce no or very low testosterone.  However, in recent years, physicians have prescribed the drug for so-called “off-label” uses, in which older men with flagging energy and libido take the drug in order to recapture their youthful zip and sex drive.  For instance, frequently aired commercials for AndroGel, a widely-used testosterone gel used to treat low testosterone suggest that older men talk to their doctors if they believe that they have “low T.”

However, there is little clinical evidence to suggest that the drug will provide these kinds of benefits.  Moreover, many health officials worry that testosterone replacement drugs are being prescribed for men with relatively normal levels of testosterone.  These worries that have been compounded by the risk of heart attack and other side effects from AndroGel and other testosterone therapies suggested in recent studies.

Such studies have prompted some to take legal action.  On February 4, 2014, five men filed a testosterone therapy lawsuit in a Chicago court against Abbot Laboratories and AbbVie, Inc., makers and marketers of AndroGel, charging that they concealed or downplayed the heart risks associated with their drug.  The men claim to have had heart attacks or strokes after taking the drug, and were not warned that heart problems might be a risk.

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