science
HHS Requests Testosterone Therapy Label Updates to Reflect New Safety Data
The Department of Health and Human Services asked for changes to testosterone replacement therapy labels on Thursday, including removal of a 2015 statement on age-related low testosterone.
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U.S. Department of Health and Human Services requested revisions to the labels on testosterone replacement therapies for men after reviewing new data and evidence on their safety and benefits, the agency announced Thursday. The requested label changes include removing the statement that the safety and effectiveness of testosterone replacement therapy have not been established in men with age-related low testosterone.
The agency also requested updating information related to prostate cancer risk and revising warnings regarding enlarged prostate. “By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men,” HHS Secretary Robert F. Kennedy Jr.
Said in the announcement. U.S. Food and Drug Administration required label changes on testosterone therapy stating that safety and effectiveness had not been established for men with signs and symptoms associated with idiopathic hypogonadism.
That limitation was added because evidence of benefit was limited and concerns had been raised about possible cardiovascular risks, according to HHS. A large clinical study involving more than 5,200 men found no “meaningful increase” in major cardiovascular events such as heart attack or stroke among people receiving testosterone therapy, HHS said.
Current labels on testosterone therapy generally advise against its use in men who have known or suspected prostate cancer and caution that treatment may increase the risk of developing the disease.
More recent research data have not generally shown an increased risk of prostate cancer in men receiving testosterone replacement therapy, the agency said. Under the requested revisions, testosterone therapy would be advised against only in men whose prostate cancer has spread. Current labels on therapies generally warn that testosterone therapy may worsen symptoms of benign enlarged prostate.
