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FDA Researchers Express Concerns About Testosterone Therapy

heart problems

In the August 20, 2015 issue of the New England Journal of Medicine, FDA researchers published an article that expressed their concerns regarding testosterone therapy side effects. Specifically, they are concerned about the use of these products by men who have declining testosterone caused by the natural aging process, rather than by a medical condition such as hypogonadism.

FDA officials have urged the manufacturers of products such as AndroGel, Axiron, and Testim to work together on new clinical trials to prove that men without hypogonadism may indeed benefit from testosterone therapy drugs. The article comes on the heels of growing concern regarding the potential side effects of testosterone therapy.

Some men have filed product liability lawsuits against the manufacturers of these drugs, alleging complications such as stroke and heart attack.

FDA’s position on testosterone therapy drug side effects

Dr. Christine P. Nguyen was the lead author of the article in the medical journal. She is also the deputy director of Safety in the Office of Drug Evaluation at the FDA. She and other health officials highlighted the importance of a single, “definitive” safety trial to evaluate the cardiovascular safety of these products. According to the article, the trial is necessary, given that “the widespread use of testosterone for age-related hypogonadism, the lack of substantial evidence to support such use, and the unknown effect of the label changes on prescribing patterns, the cardiovascular safety of testosterone products in older men remains an important public-health concern.”

This perspective follows an advisory meeting at the FDA, which resulted in a briefing report that raised concerns over prescribing habits. It noted that 28 percent of men who received an initial prescription for testosterone therapy products did not have their serum testosterone levels measured first, indicating that the physicians only evaluated the patients’ symptoms.

The FDA also reviewed five retrospective cohort studies and two meta-analyses that evaluated cardiovascular outcomes in testosterone therapy patients. Two of the retrospective cohort studies revealed a significant increase in adverse cardiovascular complications; however, the review as a whole revealed conflicting data.

As a result, the advisory panel recommended that testosterone therapy manufacturers be required to explain on the labels that the safety and efficacy of the products for age-related testosterone decline has not yet been established. The panel also recommended that the labels advise men to undergo serum testosterone testing before using the products.

Testosterone therapy lawsuits

The allegedly aggressive marketing tactics used by Low T product manufacturers has been brought up in many testosterone therapy lawsuits. The plaintiffs claim that the defendants aggressively marketed these products toward men who did not have a medical reason to use testosterone products. Plaintiffs also typically claim that the manufacturers failed to provide adequate warnings of the potential for life-threatening testosterone therapy side effects.

The rise in testosterone therapy lawsuits came on the heels of several studies that highlighted the potential for severe complications. One such study was published in the November 2013 issue of the Journal of the American Medical Association (JAMA). It suggested that older men who took testosterone therapy products after undergoing coronary angiography were more likely to subsequently suffer a stroke, heart attack, or sudden death.

  1. Medscape, FDA to Testosterone Makers: 'Work Together on a Single Trial',
  2. FDA, FDA Drug Safety Communication,