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FDA Says Testosterone Products Must Include Warning Label regarding Blood Clots

Written by Ankin Law Office

The U.S. Food and Drug Administration (FDA) recently announced that it will now require testosterone manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins.

Blood clots in the veins – which are also known as venous thromboembolism (VTE) – include both deep vein thrombosis (DVT) and pulmonary embolism (PE). According to the FDA, “[t]he risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.”

It is important to note that this new warning label requirement applies to blood clots in the veins, and is not related to the FDA’s ongoing investigation into the risk of stroke, heart attack, and death associated with testosterone replacement therapy. The FDA is continuing to evaluate the risk of stroke, heart attack, and death (which are related to blood clots in the arteries), and health care professionals and consumers are asked to report any adverse reactions to the FDA’s MedWatch Safety Information and Adverse Event Reporting program by submitting a report online at or faxing a report to 1-800-FDA-0178.

Lawsuits against testosterone manufacturers continue to rise, particularly in light of a 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.

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

Moreover, a recent study published in the Journal of Alzheimer’s Disease found that testosterone therapy appears to damage brain cells in Caucasian men with elevated levels of oxidative stress, which may raise their risk of dementia.

Contact a Testosterone Lawsuit Lawyer

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

The Chicago testosterone injury 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.

Categories: Product Liability