Consumer Organizations Demand New Warnings on Testosterone Therapy

By Levin Simes
March 4, 2014

On January 31, 2014 the FDA published a warning on the risks of testosterone therapy1. This warning prompted news organizations to cover stories about these new risks, and now prominent consumer productions agencies are calling for changes to the warning labels of testosterone therapy products2.

Public Citizen is a consumer advocacy organization with more than 300,000 members and supporters nationwide, and on February 25th 2014 they published a letter3 sent to Margaret A. Hamburg, the commissioner of the Food and Drug Administration (FDA). In the letter they request:

(1) immediately add a black box warning about the increased risks of heart attacks and other
cardiovascular dangers to the product labels of all testosterone-containing drugs presently
on the market in the United States;

(2) ask manufacturers to send “Dear Doctor” letters to warn physicians of these serious
adverse effects;

They call for these new warnings in light of the mounting evidence on the high risk factors from testosterone therapy. One study showed a 30% increase in the risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy. Another study reported a 100 percent increase in the rate of heart attacks among men aged 65 years and older in the first 90 days following the first prescription of testosterone.

Most troubling, a 2013 meta-analysis of testosterone studies noted that studies sponsored by pharmaceutical companies failed to find any risk, but those not sponsored by companies selling testosterone therapy noted a 106% increase4.

Millions of Americans received testosterone therapy without being told of the risks of heart attack, stroke, blood clots, and death. Many Americans who suffered injuries while taking testosterone would not have taken the drugs had they received a fair and full warning. These products include:

• Androgel
• Androderm
• Axirom
• Bio-T-Gel
• Delatestryl
• Depo-Testosterone
• Fortesta
• Striant
• Testim
• Testopel

Learn More about Filing a Testosterone Therapy Lawsuit

If you or a love one has been injured while taking testosterone replacement therapy, please contact one of our experienced pharmaceutical attorneys at Levin Simes LLP for a free case review and legal consultation. Contact Levin Simes at (415) 426-3000 or contact us online by completing the free consultation form.

(1) January 31, 2014 FDA Safety Announcement – FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-approved Testosterone Products
(2) February 25, 2014 Reuters article by Toni Clarke. Testosterone drugs should warn of cardiac risk, consumer group says.
(3) February 25, 2014 Public Citizen Letter to Margaret Hamburb, Commissioner of the Food and Drug Administration.
(4) March 3, 2014 Post by Levin Simes LLP. Did Studies Sponsored by Pharmaceutical Companies Hide Risks of Testosterone?

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