June 18 (Reuters) - The U.S. health department said on Thursday it was seeking updates to labels for testosterone replacement therapies after reviewing new clinical data and other evidence.
The proposed changes would remove limits on use in men with age-related low testosterone, revise warnings on enlarged prostate and update information related to prostate cancer risk, the U.S. Department of Health and Human Services said.
The move could make it easier for doctors to prescribe the therapy to a wider group of men and marks the latest effort by the department under the Trump administration to ease restrictions on hormonal treatments.
In 2015, the U.S. Food and Drug Administration required testosterone therapy labels to state that the safety and effectiveness of the treatment had not been established in men with signs and symptoms associated with idiopathic hypogonadism, a condition involving low testosterone levels without a known underlying cause.
HHS said newer evidence, including a large study of more than 5,200 men, found no meaningful increase in the risk of major heart-related events, such as heart attack and stroke, among men receiving testosterone therapy.
Based on its review of these findings and other available evidence, the FDA has concluded that the limitation of use is no longer warranted, the agency said.
Current labels of testosterone replacement therapies warn that their use may increase the risk of developing prostate cancer. However, under the new FDA revisions, the therapies use would be contraindicated only in men with metastatic prostate cancer."
According to HHS, the FDA's review found that available data have not generally shown an increased prostate cancer risk with testosterone therapy, though doctors should still assess patients before treatment and monitor them during therapy.
For enlarged prostate, HHS said the FDA's review found no worsening of symptoms in men with mild to moderate disease, though patients with severe symptoms should continue to be monitored.
Last year, the FDA removed boxed-warning language on increased heart-related risks from testosterone products, while adding or updating warnings about increased blood pressure.
Current FDA-approved testosterone formulations include oral, topical gel, transdermal patch and injections.
Source (Archive)
The proposed changes would remove limits on use in men with age-related low testosterone, revise warnings on enlarged prostate and update information related to prostate cancer risk, the U.S. Department of Health and Human Services said.
The move could make it easier for doctors to prescribe the therapy to a wider group of men and marks the latest effort by the department under the Trump administration to ease restrictions on hormonal treatments.
In 2015, the U.S. Food and Drug Administration required testosterone therapy labels to state that the safety and effectiveness of the treatment had not been established in men with signs and symptoms associated with idiopathic hypogonadism, a condition involving low testosterone levels without a known underlying cause.
HHS said newer evidence, including a large study of more than 5,200 men, found no meaningful increase in the risk of major heart-related events, such as heart attack and stroke, among men receiving testosterone therapy.
Based on its review of these findings and other available evidence, the FDA has concluded that the limitation of use is no longer warranted, the agency said.
Current labels of testosterone replacement therapies warn that their use may increase the risk of developing prostate cancer. However, under the new FDA revisions, the therapies use would be contraindicated only in men with metastatic prostate cancer."
According to HHS, the FDA's review found that available data have not generally shown an increased prostate cancer risk with testosterone therapy, though doctors should still assess patients before treatment and monitor them during therapy.
For enlarged prostate, HHS said the FDA's review found no worsening of symptoms in men with mild to moderate disease, though patients with severe symptoms should continue to be monitored.
Last year, the FDA removed boxed-warning language on increased heart-related risks from testosterone products, while adding or updating warnings about increased blood pressure.
Current FDA-approved testosterone formulations include oral, topical gel, transdermal patch and injections.
Source (Archive)
