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Should Testosterone Products Contain a Heart Attack Warning on Labels?

Written by Ankin Law Office

In light of recent data indicating that testosterone is dangerous for many men, Public Citizen – a public advocacy group – is calling on the U.S. Food and Drug Administration (FDA) to require black box warnings about heart attack and stroke risks to be included on the labels of testosterone products. The black box warning – the strongest warning that can be required of product manufacturers – alerts consumers that a product has a high risk of causing adverse health conditions, including medical conditions that can be fatal.

According to Public Citizen, more than five million prescriptions for testosterone replacement therapy were filled in the U.S. in 2013, nearly 90 percent of which were Androgel, Axiron, Testim, and Fortesta.

“Unless the FDA immediately begins to provide strong, adequate black-boxed warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks, many in people who are not even candidates for testosterone, will continue,” representatives of Public Citizen said in a press release. “At the present rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country. Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks.”

Dangers of Testosterone Replacement Therapy

Public Citizen said that its black box request was prompted by the most recent study finding that the risk of heart attacks among men 65 and older during the first three months of using testosterone was twice the risk seen in the year before use. The study also found a nearly threefold increase in heart attack risk among men under 65 with a history of heart disease who took testosterone.

“It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks,” Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, said in a press release.

In addition to risk of stroke and heart attack, testosterone therapy has a number of other side effects, including:

  • Acne and oily skin
  • Lower sperm count (which can cause infertility)
  • Higher red blood cell count (which can increase risk of heart attack and stroke)
  • Shrinkage of the testicles
  • Larger breasts
  • Worsening of urinary symptoms
  • Increased male pattern baldness

Liability for Testosterone-Related Medical Conditions

Manufacturers of unsafe pharmaceuticals, including testosterone gels and other forms of testosterone therapy, can be held accountable for their products. If you have suffered testosterone side effects, you may be able to recover money damages for medical bills, lost wages, and emotional distress. Additionally, doctors who negligently and unnecessarily prescribe testosterone replacement therapy could be liable in a medical malpractice lawsuit.

The Chicago testosterone attorneys at Ankin Law Offices, LLC are committed to protecting the victims of unsafe pharmaceuticals, such as testosterone replacement therapy. We have considerable experience representing clients in a wide variety of personal injury and product liability lawsuits, including class actions lawsuits based on unsafe pharmaceutical drugs. If you have suffered serious testosterone side effects, contact the skilled Chicago unsafe pharmaceutical drug law firm of Ankin Law Offices, LLC at (312) 600-0000 to discuss a possible testosterone lawsuit.