FDA Calls on Advisory Committees to Recommend Action on Low T Drugs

In what is likely a precursor to the Food and Drug Administration taking regulatory action on low testosterone replacement therapy (TRT), the FDA has asked two advisory committees to meet on September 17 to evaluate the risks and reported testosterone side effects linked to so-called “Low T” drugs, such as AndroGel, Testim, AndroDerm, Axiron, Bio-T Gel, Foresta, and others.

The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will make recommendations to the FDA about what regulatory actions they suggest in light of the increasing evidence that there is a causal link between Low T drugs and heart attacks, blood clots, embolisms, strokes, even death. Although not binding, recommendations that such committees make to the FDA on various drugs or devices have a significant impact on the FDA’s actions in the marketplace.

When profits are the priority, testosterone side effects are ignored

Testosterone is a naturally occurring hormone that maintains sex drive, energy levels, muscle mass, and sperm production. Testosterone levels start decreasing in men at about 30 years of age and diminish about 1% annually. Signs of low T may include weight gain, reduced energy levels, diminished sex drive and loss of muscle strength–symptoms of hypogonadism, for which low T drugs are specifically approved.

However, these same symptoms occur naturally in men with normal testosterone levels so there is a real danger of risky testosterone replacement medications being aggressively marketed and prescribed needlessly to ward off symptoms that occur naturally with age.

A January 2014 study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism suggests that many men in the U.S. are prescribed testosterone treatments with normal levels or after a single test.

Heavy marketing of low T therapy as a “lifestyle” drug has generated enormous profits. In 2002, testosterone therapy sales were $324 million. In 2012, sales figures reached almost $2 billion in the absence of warnings of the heart risks of Low T therapy.

Testosterone therapy risks spotlighted in Low T studies

The FDA asked the committees to convene only days after Health Canada , the Canadian drug regulators, announced that their own safety review on Low T drugs showed strong links between those medications and heart issues. They also found that these cardiovascular problems appeared when using the drug, disappeared when the medication was stopped, and reappeared upon using the drug again, likely establishing a causal link.

In November 2013, a study published in the Journal of the American Medical Association (JAMA) found that testosterone therapy could increase the risk of death, heart attack and stroke by 29% among certain men, prompting the FDA to carry out its own review in January 2014.

A study involving 55,000 men was published in January 2014 in the medical journal PLOSOne which found that low T treatments could double the risk of heart attack for younger men with pre-existing heart disease and men over the age of 65 both with and without prior heart disease.

FDA rejects call to warn of testosterone drug side effects

Although the FDA issued a statement in June requiring new warnings on labels regarding the risk of venous thromboembolism (VTE), or blood clots that occur in the veins, it rejected a call to add a black box warning to all testosterone products that use of such products could cause side effects like heart attacks, strokes, and sudden death.

Citing the results of the HealthCanada study, Dr. Sydney Wolf, founder and senior health advisor of the consumer advocacy group, Public Citizen, asked if “the FDA is more sensitive to pressure from doctors dispensing more than 7 million prescriptions of testosterone in the past year and from the companies selling billions of dollars of testosterone products during the past year than Canadian regulators.”

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