An FDA advisory panel voted 20-1 Wednesday to design limits around the use of testosterone-replacement therapies, and that more information is needed to assess whether these treatments pose a cardiovascular risk.
While FDA is not required to follow its advisors’ advice, if the agency does adhere to the near-unanimous recommendations to rein in the drugs’ prescribing, often for a lifestyle-related condition known as “low-T,” could translate into a sales dip for AbbVie’s AndroGel and Eli Lilly’s Axiron.
Both drugs have seen sales grow dramatically since their introduction, with prescriptions rising over 58% since 2010 to 4.8 million last year, according to IMS Health. If the FDA tows the panel’s line, labels would narrow to include only men with low hormone levels stemming from disease or injury—and exclude those who seek treatment from age-related low testosterone.
FDA stated earlier this year that it would give testosterone replacements a second look, and review their impact, after two studies reflected an increased risk of cardiovascular issues. FDA added a warning of the general risk of blood clots to the drugs’ labels this past June.
Researchers of a study published in JAMA this past July involving 24,000 Medicare patients found that the drugs did not increase the risk of heart attack, contrary to several previous studies.
Eli Lilly is currently conducting a study of 600 men with hypogonadism to observe the benefits and safety of testosterone, results from the trial will come in 2015.