Cardiovascular Risk Associated with ‘Low-T’ Drugs Should Be Studied, FDA Advisory Panel Says
Popular testosterone-replacement drugs have been called into question by a Food and Drug Administration advisory panel, which has voted in favor of restricting their use to men with medically related low testosterone.
Currently, the drugs are marketed mainly to men with age-related low testosterone as a relatively quick and painless cure for the condition, which adversely affects sex drive and can cause depression, fatigue and loss of muscle mass.
“The panel voted 20-1 in favor of restricting the drugs’ authorization to people with medically related low testosterone, such as a genetic disorder or a tumor,” a story on NBCNews.com stated. “If implemented, the restriction would mean companies could not market or promote their products for age-related low testosterone….”
The panel, comprised of the Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees, also voted in favor of requiring companies selling low-testosterone drugs to study and assess risks associated with the cardiovascular system. One of the questions the panel voted on was worded in the FDA presentation as follows: Is the overall benefit / risk profile of oral testosterone undecanoate acceptable to support approval of this product for testosterone replacement therapy?
Prescriptions to cure “Low T” have risen dramatically since 2010. WebMD’s Medscape Medical News reported U.S. sales of the drugs have increased 65 percent through 2013 and prescriptions soared to 2.3 million in 2013, up from 1.3 million in 2010. Most of those prescriptions were written for men ages 40 to 64.
In June of 2014, the FDA warned of blood clots in the legs as a potential result of taking low-testosterone drugs and mandated that information be included on product labels. The NBCNews.com story mentions more ominous risks. “The risk of deep vein thrombosis comes on top of the suspected risks of stroke, heart attack, and death from taking testosterone pills or using testosterone creams,” it was reported.
An FDA Drug Safety Communication explains the agency-approved testosterone products target men who experience the condition because of a specific medical condition. However, doctors have been prescribing those drugs to men with age-related “Low T.”
Products come in the form of gels, injections, patches and pills.
Men who think they are having symptoms related to low testosterone levels should consult their doctor and get a blood test.