FDA Orders Re-Labeling on Testosterone Treatments to Stress Lack of “Low T” Approval

Published on March 9, 2015 by Sandy Liebhard

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U.S. health regulators reminded men this month that certain prescription therapies now involved in testosterone lawsuits are not proven effective in treating low libido and other aging issues, and may carry an increased risk of cardiovascular injuries.

The U.S. Food and Drug Administration (FDA) published a Safety Announcement on March 3, 2015 that notified men about the risks associated with medications including AndroGel, AndroDerm and Testim, as well as other products. According to the agency’s warning, labeling on these products will be adjusted to reflect their lack of approval in treating men with aging issues. Prescription testosterone treatments are only cleared in the U.S. to treat men with hypogonadism, a condition that refers to abnormally low levels of the hormone. Manufacturers including AbbVie and Eli Lilly have also been ordered to conduct clinical trials that assess a possible testosterone heart attack risk that may be associated with products that are already on the market, and produce those findings to the FDA.

Public Health Alert about Testosterone Treatments Follows Several by FDA

This is federal agency’s most recent and significant warning about testosterone drug complications. In September 2014, the FDA orchestrated a panel of advisers that voted 20-1 in favor of re-labeling the medications to note their lack of effectiveness in treating “Low T” a condition marketed by testosterone manufacturers that can be alleviated with AndroGel and other products. At the start of that year, the FDA issued its first public health alert involving testosterone problems. The warning was issued on January 31, 2014 and relayed the findings of a study that found an increased risk of strokes, heart attacks and other problems in men older than 65 and all younger men with a pre-existing history of heart disease.

Testosterone lawsuits that allege these side effects are also pending in a federal multidistrict litigation (MDL) underway in the U.S. District Court, Northern District of Illinois. Plaintiffs in these cases blame the makers of AndroGel, Testim, AndroDerm and other treatments for the cardiovascular injuries they allegedly sustained because of the drug, which they were inadequately warned about. They further accuse the companies of promoting the medications off-label for uses not approved by the FDA.

Consider a Testosterone Lawsuit. Call Us.

Call a testosterone lawyer at our Firm today for more information about heart risks that may stem from use of the prescription therapy treatments. Call us now at .