Testosterone Heart Attack, Stroke Problems Being Reviewed by FDA

Amid mounting concerns about the increased risk of heart attacks and strokes from testosterone replacement therapy, federal drug regulators have announced that they are investigating the findings of recent studies that suggest popular medications like AndroGel, Testim and other testosterone supplements may pose serious risks for men.

On January 31, the FDA announced it is investigating the safety of testosterone therapy, including the potential risk of stroke, heart attack or even death.

The agency said the decision to take a new look at the potential side effects of the popular hormone therapy came after two studies showed an increased risk of testoserone heart problems for certain men using the gels, creams, injections, pills and patches.

Testosterone therapy has increased in popularity in recent years, as direct-to-consumer marketing has encouraged men to seek prescription treatment for low testosterone levels, or “low T”, if they are experiencing fatigue, decreased sexual virility or other symptoms that are often common with aging.

In recent years the use of AndroGel, Androderm, Testim, Axiron and similar testosterone treatments has increased more than a factor of five, with more than $1.9 billion in sales in 2012.

Several studies have suggested that much of the increased use in recent years has been among men who may have no medical need for the medications. The FDA has only approved testosterone treatments for men who have low testosterone due to an associated medical condition. However, reports have suggested that many men are being prescribed the drugs without having testosterone levels tested or after normal tests.

“Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition,” the agency noted in a drug safety communication. “Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.”

Recent Studies Raise Concerns About Heart Risks with Testosterone

In November 2013, a study published in the Journal of the American Medical Association found that testosterone drugs were linked to increased risks of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by another study released last week by the medical journal PLOSOne, 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.

“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the FDA stated in a statement released on Friday. “We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.”

The FDA notes that it has not yet determined whether testosterone treatments carry an increased risk and that determination will be made after the agency looks over all the data.

The agency recommends that men prescribed testosterone treatments should not stop using them without first discussing their situation with their doctor. The FDA urges doctors and patients who experience adverse events after using testosterone products to contact the FDA’s MedWatch adverse event reporting program.

As men learn that testosterone replacement therapy may have caused heart attacks and strokes suffered in recent years, many former users are now considering potential AndroGel lawsuits and other testosterone injury lawsuits against the manufacturers, alleging that inadequate studies were conducted about the safety of the products and that information was withheld from consumers and the medical community.