FDA Testosterone Concerns Questioned in Position Statement by Endocrinologist Groups

Amid continuing concerns about potential side effects of testosterone drugs and the widespread overuse of the medication, two endocrinology groups have released a position statement indicating that they disagree with the FDA’s recent recommendations about who should be prescribed the popular medications.

The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) released a joint position statement in this month’s issue of the medical journal Endocrine Practice, questioning the FDA’s position on the controversial medications and indicating that there is a lack of evidence on whether testosterone replacement therapy (TRT) hurts or helps the heart. 

Over the past decade, testosterone drugs like Androgel, Testim, Axiron, Androderm, Depo-Testosterone and other similar medications, have grown from a niche treatment to an industry that generates more than $2 billion in sales per year. However, serious testosterone concerns have emerged over the past 18 months, following reports that suggest the drugs are widely used by men with no real medical need and amid studies that indicate testosterone medications may increase the risk of heart attacks, strokes, blood clots and other injuries.

On March 3, the FDA issued a drug safety communication to announce that it is requiring new warnings for the drugs, which indicate there is evidence of a possible link between testosterone replacement therapy and heart problems. The agency also urged doctors not to prescribe testosterone drugs to patients who had not been confirmed as having hypogonadism through serum testosterone blood tests.

The AACE has been at odds with both the FDA, as well as the Endocrine Society, over the testosterone concerns for some time. The new position statement states that the FDA’s recommendations are unclear, though they agree that potential testosterone drug recipients should be properly tested. The group also agreed, however, that the risk to benefit ratio of giving men with lower testosterone due to aging has not been established, and echoed the FDA’s calls for more rigorous studies.

Where the groups differ is on how doctors should determine who gets testosterone, which the FDA says should be based in determining that the underlying cause is actually hypogonadism.

“The decision to replace testosterone should be guided by the signs/symptoms and testosterone concentrations rather than the underlying cause,” the position statement claims. “These men should be told that we do not have definitive studies demonstrating efficacy or risk for treating men with these conditions.”

The AACE previewed its position on testosterone replacement therapy at a conference in May, when a panel called for the FDA to retract warnings about testosterone heart risks and suggestions that doctors limit prescriptions to those with demonstrable cases of hypogonadism.

Studies Lead To Testosterone Heart Attack Concerns

According to the FDA, testosterone drugs are meant to treat men suffering from hypogonadism, which causes abnormally low testosterone levels. The condition usually comes due to injuries or problems with the testicles or certain parts of the brain. The only way to confirm whether someone suffers from hypogonadism is through a serum testosterone blood test.

Following recent studies that have identified a link between low T drugs and heart attacks, the FDA and the Endocrine Society, which has about 1,800 members in 120 countries, have been pushing doctors to ensure that testosterone medications are only prescribed to men who have been properly tested.

In November 2013, research published in the Journal of the American Medical Association (JAMA) found that older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events, such as a heart attack, stroke or death.

That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.

In January 2015, another study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.

As the debate over the safety of testosterone replacement therapy continues among some in the medical community, a growing number of Androgel lawsuits, Axiron lawsuits, Testim lawsuits, Androderm lawsuits, Depo-Testosterone lawsuits and other product liability cases against manufacturers of “low T” drugs continue to be filed, alleging that inadequate research was conducted before marketing the drugs and that inadequate warnings were provided for consumers and the medical community.

The AACE and ACE position statement includes an extensive list of those involved in formulating the groups’ position who have received financial support from testosterone drug companies, including several who are paid to speak on behalf of AbbVie, the makers of AndroGel, the most widely used testosterone replacement therapy on the market.