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Testosterone product labels updated


Table of Contents

The U.S. Food and Drug Administration got what it wanted the makers of FDA-approved testosterone products to do this past spring. The manufacturers updated the labels on all approved prescription testosterone products to do the following:

  1. Clarify those uses that the FDA has permitted
  2. Reflect a potential increased risk of heart attacks and strokes

“Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use,” the agency reported. “These studies included aging men treated with testosterone.”

These medications have been billed as a common Low-T treatment for the effects of aging, but that was not exactly what the FDA had in mind when it approved some of these testosterone products. The agency approved a more narrow use.

As the agency explained in a statement, “Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

The federal regulatory body went on to explain, “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of the possible increased cardiovascular risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.”

Researchers writing for the April 18, 2013, edition of the journal BMC Medicine analyzed numerous studies that medical journals published through the end of 2012. The studies were published in English and were listed in the World Health Organization trial registry. Researchers examined nearly 1,900 studies, and they narrowed it down to 27 that centered on nearly 3,000 men who had experienced 180 “cardiovascular-related events.” All of these studies were randomized and placebo-controlled, so the risk for those using the products could be compared with that of those who did not use testosterone meds. Further, these studies lasted at least 12 weeks.

The physicians determined that “exogenous testosterone increased the risk of cardiovascular-related events, with corresponding implications for the use of testosterone therapy.”

What about studies that the manufacturers conducted? Researchers noticed something peculiar about the relationship between clinical outcomes and study sponsors.

“The cardiovascular-related event rate was lower in trials funded by the pharmaceutical industry than in other trials,” the authors wrote. “In a meta-regression model, risk of cardiovascular-related events on testosterone therapy varied with the source of funding but not with baseline testosterone. In trials funded by the pharmaceutical industry, testosterone had no effect on cardiovascular-related events, but in the other trials testosterone therapy substantially increased the risk of a cardiovascular-related event.”

Not throwing the baby out with the bathwater, researchers thus concluded, “Appropriately prescribed testosterone is undoubtedly beneficial. However, caution needs to be exercised to ensure that the associated health benefits of testosterone therapy outweigh the potential increased risk of cardiovascular-related events, particularly in older men where cardiovascular disease is common.”

Testosterone therapy lawsuits are still being filed across the country in state and federal courts. At the federal level, a panel of judges in June 2014 centralized for group pretrial management numerous cases. The number of centralized cases placed before the U.S. District Court for the Northern District of Illinois stood at 1,768 as of June 15.

“All actions,” the U.S. Judicial Panel on Multidistrict Litigation wrote in regard to those cases, “involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism. All testosterone replacement therapy actions will share factual questions regarding general causation and the background science regarding the role of testosterone in the aging body (possibly including examination of the recent studies that prompted the FDA investigation), as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.”

Those who suffered a cardiovascular event following the use of a testosterone product may learn from an experienced pharmaceutical injury attorney whether they may be entitled to compensation for their injuries.

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