On March 3, 2015, the Food and Drug Administration began requiring drug makers to caution patients that testosterone medications may escalate the risk of heart attacks and strokes.
The FDA originally approved testosterone gel only for men with low testosterone levels due to medical problems, such as effects from chemotherapy or genetic deficiencies. However, doctors and clinics have been prescribing the gels to treat the effects of aging, something the FDA never approved. The safety and benefit of these drugs have not been tested for treating low testosterone (Low T) levels due to aging. Consequently, the FDA is requiring that manufacturers use new labels detailing the exact approved use of these medications.
This new, widespread use of the drug has caused the agency to take a hard look at the possible increased risk of heart attack, stroke, and death associated with the hormone treatment. Some studies with aging men have pointed to the drug’s link with these diseases. As a result, the agency is requiring drug makers to add labeling information about the potential elevated risk of cardiovascular disease in patients. Another FDA stipulation: mandating that drug corporations carry out a study, defining just how risky testosterone treatment is.
Carey Danis & Lowe represents men who have been harmed by testosterone gels. If your health has been impaired by the use of testosterone gels, we suggest that you discuss legal possibilities and compensation eligibility with one of our personal injury lawyers.
Contact Carey Danis & Lowe by phone at 800.721.2519, or complete a confidential personal injury claim form.References: Pharmaceutical litigation, Testosterone