On June 19, 2014, the FDA issued a labeling change for all testosterone products. The FDA noted that prior labels only warned about a risk of blood clots in connection with polycythemia (an increased red blood cell count). However, the FDA noted many of the reports of blood clots are unrelated to polycythemia. Therefore, the FDA is broadening the warning to a general risk of blood clots.
This change in labeling impacts lawsuits where a person had a blood clot in their legs, lungs, or any other vein that was not the result of an increased red blood cell count. The change suggests that prior warnings were inadequate to warn about these events.
If you or a loved one had a pulmonary embolism, blood clot, stroke or heart attack while taking a testosterone medication, please call our experienced AndroGel attorneys at (888) 606-5297 for a free consultation about your potential AndroGel lawsuit.