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FDA requires labeling changes for testosterone therapies to reflect CV risk

March 3, 2015

The FDA has announced that manufacturers of prescription testosterone products must change their labeling to more clearly indicate approved uses and also include a warning about possible increased risk for MI and stroke.

According to a FDA drug safety communication, the agency recommends that health care professionals prescribe testosterone therapy only for men with laboratory confirmed low testosterone as a result of certain medical conditions of the brain, pituitary gland or testicles that result in hypogonadism. This is the only patient population for which these products have been approved.

In the Journals

Hormone therapy in transgender adults appears safe

February 25, 2015
A literature review recently published in the Journal of Clinical and Translational Endocrinology suggests that use of hormone therapy in transgender adults is…
FDA News

Flibanserin to treat hypoactive sexual desire disorder in premenopause goes back to FDA

February 17, 2015
Sprout Pharmaceuticals has resubmitted a new drug application to the FDA for flibanserin, an investigational therapy to treat hypoactive sexual desire disorder in women…
In the Journals

Hormone replacement therapy increases risk for ovarian cancer

February 12, 2015
Women who used hormone replacement therapy — even only for a few years — demonstrated an increased risk for serous and endometrioid ovarian cancer, according…
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