Testosterone drug makers must now supply their products with stricter labeling about the risk for blood clots in all users, not just those suffering from polycythemia, a condition associated with an abnormally-high red blood cell count, the U.S. Food and Drug Administration (FDA) ordered in June.

According to WebMD.com, the FDA announced on June 20th that it received numerous reports of blood clots unrelated to polycythemia in patients taking “Low T” medications, and that stronger warnings are necessary. “Low T” medications already include warnings about blood clots in the veins, which include deep vein thrombosis (DVT) and pulmonary embolism in conjunction with this condition. The FDA’s call for newly-adjusted testosterone drug warnings follows another FDA announcement issued earlier this year; this one involving the risk for AndroGel, Axiron and other medications to serious cardiovascular side effects.

FDA Warns about “Low T” Testosterone Treatments

On January 31, 2014, the federal agency issued a public health alert about certain “Low T” drugs’ potential to cause strokes, heart attacks and death in younger men with pre-existing heart conditions, as well as all older men who may or may not have a history of cardiovascular problems. The FDA’s alert in January warned at the time that the alleged link between the hormone-raising drugs and the risk for serious heart problems had not been confirmed, but was a subject of federal investigation.

Since then, dozens of testosterone lawsuits have been filed on behalf of men who allegedly suffered these side effects after taking AndroGel and other medications. Many “Low T” lawsuits are now pending in the U.S. District Court, Northern District of Illinois, where a federal multidistrict litigation (MDL) was recently created. According to a federal update on June 16th from the U.S. Judicial Panel on Multidistrict Litigation (JPML), a total of 98 lawsuits have now been filed by men who similarly accuse drug manufacturers of failing to adequately warn about serious side effects associated with their products, which they promoted for off-label uses not approved by the FDA. Instead of marketing the drugs for abnormally-low testosterone levels in conjunction with a medical condition, such as hypogonadism, manufacturers were pushing sales for the treatment of fatigue, low libido and other symptoms associated with aging.

Contact a Testosterone Lawyer Today

Call our Firm today to learn more about FDA warnings about certain “Low T” testosterone medications, and to find out if you are eligible to file a claim at (877) 779-1414.

Published June 23, 2014 by