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FDA Announces New Testosterone Labeling Rules

Nov 01, 2016

FDA Announces New Testosterone Labeling Rules

Labels on all testosterone products must now include information about the risk of abuse, according to a ruling issued by the U.S. Food and Drug Administration (FDA) last week.

The agency explained that the labeling change stems from published literature and case reports on the abuse of testosterone and other anabolic androgenic steroids.

Produced by the testes, testosterone is an important hormone for men. It creates and maintains many of their masculine characteristics, including facial hair, muscle mass, and a deep voice. It is also involved with sex drive and erections.

Doctors may prescribe testosterone when men’s bodies don’t produce enough of it on their own. For example, certain genetic conditions, chemotherapy, infection, and injury to the testes can all affect a man’s testosterone production. Currently, the FDA approves the use of testosterone for men in these situations.

However, testosterone levels naturally decline as men get older. As a result, men may feel weak, fatigued, and irritable. They may also lose interest in sex and have problems getting erections. Sometimes, doctors prescribe testosterone to treat these symptoms.

Some men abuse testosterone, taking more than the recommended dose and/or taking it with other anabolic androgenic steroids. Some athletes and bodybuilders take testosterone or other drugs to enhance their performance.

The FDA reports that testosterone abuse can damage the heart, brain, liver, and the endocrine system. It may also affect a man’s mental health.

“Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility,” the FDA said in a press statement, adding that men undergoing withdrawal from testosterone may have symptoms such as “depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.”

The FDA also advised healthcare providers to measure a man’s testosterone if they suspect he is abusing the hormone.

Resources

LiveScience.com

Rettner, Rachel

“Prescription Testosterone Gets New Warning”

(October 25, 2016)

http://www.livescience.com/56640-prescription-testosterone-warning.html

 

MD Magazine

Black, Ryan

“FDA Announces Stern New Warning Labels for Testosterone Treatments”

(October 25, 2016)

http://www.hcplive.com/medical-news/fda-announces-stern-new-warning-label-requirements-for-testosterone-treatments

 

Medscape

Brooks, Megan

“FDA Adds New Warnings to All Testosterone Product Labels”

(October 25, 2016)

http://www.medscape.com/viewarticle/870932

 

Reuters

Clarke, Toni

“U.S. FDA adds abuse warning to prescription testosterone”

(October 25, 2016)

http://www.reuters.com/article/health-testosterone-fda-idUSL1N1CV1MA

 

U.S. Food and Drug Administration

“FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS)”

(Press statement. October 25, 2016)

http://www.fda.gov/Drugs/DrugSafety/ucm526206.htm