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Consumer Advocacy Group Calls for Black Box Warning on Testosterone Therapy Treatments

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The Public Citizen group is asking the FDA to put warning labels on testosterone therapy treatments after several recent studies have highlighted the potential risk for heart attack, stroke and death among those using these drugs.

The petition, released on February 25th, 2014, cites data from IMS Health Inc. showing more than 5 million testosterone therapy treatment prescriptions were filled in 2013.  Public Citizen urged the FDA to ask manufacturers to send a “Dear Physician” letter to warn doctors about serious side effects, add a “black box warning” about the heart attacks risks, and update the medication guide for all testosterone products.  Public Citizen is also asking the FDA to “delay its decision date on approving a new long-acting injectable testosterone product Aveed (testosterone undecanoate, Endo)” which is expected on February 28th, 2014.

The FDA announced plans to investigate the use of testosterone therapy treatment on January 31st, 2014.  In the FDA’s safety announcement the agency said in part that it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”

In its petition, Public Citizen called this statement a “betrayal of its role in the U.S. Public Health Service.”

FDA-Approved Use for Testosterone Therapy Treatments

The FDA only approves the use of testosterone therapy treatment for men who have low testosterone levels due to a medical condition.  Public Citizen argues that advertising campaigns for testosterone treatment are not regulated enough and are causing men who do not actually need to be on testosterone therapy to seek treatment from doctors.

A study published in JAMA Internal medicine, Trends in Androgen Prescribing in the United States, 2001 to 2011 found a three-fold increase of androgen use in men aged 40 and older.  Topical gel was found to be the most popular form of testosterone treatment during that time period.

A substantial marketing push in 2012 was for forms of treatment that were easier to use including the topical gels and patches.  These were intended to grab the attention of healthy older men with naturally decreasing levels of testosterone, or androgen deficiency.

Do You Need Testosterone Therapy Treatment?

Testosterone therapy treatment has been touted as having several positive side effects for men, including helping with regaining energy, sex drive and libido, which can naturally decrease with aging.

Only a doctor can determine if you need treatment for low testosterone.  He or she should administer a test to measure the level of testosterone in your blood.  You should not start or stop a form of testosterone therapy treatment without permission from your physician.