Product News and Recalls

FDA Adds New Warning for Testosterone Therapy Products

The Food and Drug Administration (FDA) recently issued a new safety alert stating that men who use testosterone therapy products are at an increased risk for venous blood clots, a condition referred to as venous thromboembolism (VTE). The FDA is requiring all manufacturers of testosterone therapy products to include on labels a general warning about the heightened VTE risks.

Venous blood clots are as they sound — blood clots that occur in the veins. They can occur in the lungs, known as a pulmonary embolism (PE), and block the flow of deoxygenated blood from the heart to the lungs. They can also occur elsewhere in the deep veins of the body, known as a DVT. These usually occur in the legs, and may eventually travel to the lungs and cause a PE.

VTEs can be life-threatening if not properly treated in a timely manner. Even if a person discovers a clot in a timely fashion, treatment may be extensive, possibly requiring extended hospital stays, new drug regimens, and even surgery to remove a clot or insert a filter.

Plaintiffs filing testosterone lawsuits allege that, until this new FDA requirement, manufacturers had not provided adequate warning to medical professionals or consumers of the high risk of blood clots. If you have suffered blood clots from using any type of testosterone product, you may be entitled to substantial compensation from the respective pharmaceutical manufacturer.

Other Risks of Testosterone Therapy

In January of 2014, the FDA issued a different safety warning, informing consumers that it was looking into reports of severe cardiovascular events in users, including strokes, heart attacks, and death.

Additionally, the FDA stated it had not approved testosterone products for men who lacked a medical condition associated with low testosterone. However, testosterone therapy manufacturers continue to market their products to men with no medical conditions, but who simply have symptoms such as decreased libido, loss of body hair, or fatigue. These symptoms are often a natural byproduct of aging.

The pharmaceutical attorneys of Lopez McHugh, LLP are actively consulting with men who have suffered serious adverse health conditions due to prescription testosterone products. Do not hesitate to call us today at (877) 737-8525 to discuss a possible case.