Androgel Side Effects May Increase Prostate Risks in Older Men: Study

The findings of new research suggest that side effects of Androgel may cause older men to face an increased risk of suffering prostate problems. 

Researchers from Harvard and AbbVie Inc., the makers of the popular testosterone gel, published a study in this month’s issue of the Journal of Sexual Medicine that looked at the levels of prostate-specific antigens (PSAs) in men using Androgel.

While most men appeared to be unaffected, men over the age of 60 saw increased PSA levels with Androgel use..

While the effects of the increased PSAs is unclear and those levels are not used to screen for prostate cancer, high levels of PSAs have been linked to an increased risk of prostate cancer and other prostate problems.

The study involved a double-blind, placebo-controlled study of 274 men with low testosterone due to hypogonadism. AndroGel was given to 234 of the men for six months, while 40 were given a placebo.

Researchers found that overall, the men saw a slight increase in PSAs, though about a quarter of them saw a much more significant increase. The study determined that men age 60 or older showed a greater PSA increase than in younger men. In men given a placebo, the PSA levels decreased compared to the baseline.

The clinical significance of the findings were unclear, according to the researchers. The lead study author, Dr. Abraham Morgentaler, is a founder of the Androgen Study Group, which has actively worked to refute concerns about testosterone drug risks. Morgentaler has served on the science board for Auxilium, the makers of the testosterone drug Testim, and co-author Janet Benesh is a neuroscience development project director for AbbVie.

Androgel Heart Risks

The study comes amid rising concerns over the potential cardiovascular risks associated with Androgel side effects, following the publication of several studies earlier this year and recent FDA advisory panel meetings convened to evaluate what regulatory actions may be necessary to protect consumers.

In November 2013, a study published in the Journal of the American Medical Association (JAMA) linked testosterone to higher rates of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

This research was followed by a study published by the medical journal PLOSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

The FDA launched its own testosterone investigation shortly after the release of this research. indicating that the agency is reviewing the cardiovascular risks among men taking any approved testosterone drugs to determine what regulatory actions may be necessary.

Two FDA advisory committees met this summer to evaluate the available data and voted 20-to-1 to recommend that the drug makers be forced to conduct additional clinical trials to evaluate the potential heart risks. The panels also recommended that the FDA restrict use of the widely used medications to men actually suffering from testosterone deficiencies caused by hypogonadism or another medical condition.

AbbVie currently faces a mounting number of Androgel lawsuits, which allege that the drug maker recklessly promoted the medications without adequately warning consumers and the medical community. Similar testosterone drug lawsuits have also been filed against makers of competing products, including Testim, Axiron, AndroDerm and other “Low T” gels, creams, patches, injections and other treatments.