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FDA Panel Backs New Testosterone Drug Safety Limits

Androgel packageAmid concerns over testosterone therapy side effects, an FDA panel has backed limitations on labeling for testosterone to exclude prescriptions for men who take the therapy only to counteract ordinary signs of aging rather than specific hormonal abnormalities. The panel also voted overwhelmingly to require clinical safety trials for some forms of testosterone therapy. Though the FDA is not bound by the panel’s findings, it frequently accepts suggests offered.

Testosterone therapy was once used only for the treatment of hypogonadism, in which the body produces little to no testosterone due to illness or injury. The FDA has approved this use for testosterone therapies once doctors have performed a blood test and a thorough examination to determine that a patient indeed has this condition.

However, drug companies in recent years have advertised forms of testosterone therapy as a treatment for “Low T,” essentially defined as the natural decline of testosterone production that the male body begins to experience after 30. While this process was not formerly a “condition” that doctors treated, pharmaceutical companies advertised aggressively to older men, promising renewed vigor and libido, and doctors have prescribed testosterone to millions of men for this “off-label” use.

There have been concerns that such claims are unsubstantiated an inappropriate. Dr. Michael Domanski, one of the 20 expects on the panel who voted to change the labeling, summarized that “The whole idea is to try to rein in the inappropriate advertising and use of these drugs.”

FDA concerns over testosterone drug safety

A study published in the January 2014 edition of PLoS One found connections between testosterone therapy and heart attack in men over 65 and younger men with a documented risk of heart problems. Two earlier studies, one published in the Journal of the American Medical Association found increased rates of heart attack, stroke, and death in men who received the therapy.

The PLoS One study prompted many in the public health field to call for a heart attack warning on labels. The FDA announced at the beginning of the year that it would be evaluating the link between testosterone drugs and heart-related incidents and deaths reported in some studies. After sifting the evidence, the FDA panel reported that results had been mixed and therefore required additional clinical safety trials.

Of the many discomfiting testosterone drug safety facts brought to light was this revelation: 20% of men prescribed testosterone therapy had not received a base-line blood test from their doctors to determine testosterone levels.

Heart attacks and other testosterone side effects trigger lawsuits

As information about heart risks and testosterone therapy became more widely known, men who had suffered heart related problems while taking testosterone, or family members of those had had died of purportedly testosterone-related heart issues, began to file lawsuits over these injuries of losses. Plaintiffs claimed that heart-risks were not disclosed in advertising and labeling.

The first lawsuits were filed over the popular brands AndroGel and Testim, though other brands may be implicated in upcoming months. By June, a sufficient number of plaintiffs had filed testosterone therapy lawsuits to necessitate the formation of a multidistrict litigation (MDL) established in the Northern District of Illinois (Chicago).

The MDL will entail a common pre-trial discovery phase for all litigants, though trials will be held separately.

  1. NY Times, FDA Backs Limits on Testosterone Drugs
  2. NPR, Popular Testosterone Therapy May Raise Risk Of Heart Attack…
  3. JPML,MDL No. 2545 Transfer Order,
  4., FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products