“Low T” Testosterone Drugs May Not Benefit Most Men, FDA Says in September Review

Published on September 4, 2014 by Sandy Liebhard

AndroGel and other testosterone treatments may not benefit men without abnormally low levels of the hormone, despite manufacturer claims that they are effective in treating common symptoms of aging, the U.S. Food and Drug Administration (FDA) said this week.

The federal agency posted a review on September 3rd that referred to some prescription therapy treatments as “controversial” in men who aren’t suffering from hypogonadism, a condition referring to extremely low male hormone levels. Oftentimes, otherwise healthy men who may be fatigued, have low libido or be suffering from muscle loss are prescribed AndroGel, Testim and other medications advertised to treat these “Low T” symptoms, by their doctors. The FDA argues in the review that “the need to replace testosterone in these older men remains debatable.”

At the time this federal review was published, these prescription therapies were only approved to treat men suffering from hypogonadism, and had been named in dozens of testosterone lawsuit filings.

FDA Scheduled to Discuss Testosterone Drug Risks at September Meeting

Interestingly, the U.S. regulator released its testosterone drug review two weeks shy of a September 17th meeting scheduled to assess their possible cardiovascular side effects.  This meeting follows an FDA warning in January that vowed to conduct a full safety review of AndroGel, Testim and other products after two federally-funded studies found an increased risk of strokes, heart attacks, and other serious cardiovascular events in all older men, and younger men with pre-existing heart disease. The first one was published in November 2013 by the U.S. Veterans Affairs, and showed a 30 percent likelihood of serious heart events in older men taking testosterone products. The second found a doubled risk of heart attacks in users older than 65.

According to Fox News, the FDA mentions in its September review that these associations have not been confirmed. They have been alleged, however, in dozens of testosterone drug lawsuits now filed on behalf of men who experienced heart attacks, strokes and other heart events after taking AndroGel and other medications. A Case List updated on August 15th shows that 177 claims have now been centralized in a federal litigation established in the U.S. District Court, Northern District of Illinois. These cases were brought by men who blame drug manufacturers for injuries they allegedly sustained, and accuse them of withholding vital product safety information from the public.