FDA calls for Testosterone Label Change

androgel-pictureAn FDA Drug Safety Communication on March 3, 2014 cautioned that testosterone products used for low testosterone due to aging require a labeling change regarding possible increased risks of heart attacks and strokes. The FDA has also concluded that “based on the available evidence from published studies and expert input from an Advisory Committee meeting, (there) is a possible increased cardiovascular risk associated with testosterone use.”

This information updates the FDA’s Drug Safety Communication issued on  January 31, 2014 regarding the agency’s evaluation of the risk of stroke, heart attack and death associated with FDA-approved testosterone products.

Low-T Therapy not approved for Aging

The FDA in the announcement cautions that prescription testosterone products are approved only for men with low testosterone levels due to certain medical conditions. Any benefits and the safety of these “Low-T” medications have not been established for the treatment of low testosterone levels brought on by aging, regardless of whether a man’s symptoms appear to be related to low testosterone.

The agency is consequently now requiring Low-T product makers to change their labeling to clarify the approved uses of these medications. FDA is also requiring Low T therapy product makers to add labeling information regarding  a possible increased risk of heart attacks and strokes.  This label change includes the language: “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”

Testosterone approved only for Certain Disorders

Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.

These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.

FDA finds Label Change needed

FDA said it is “requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy.”

Clinical Trials Needed

FDA said it is also requiring testosterone product makers to conduct a “well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists” among Low T product users. The agency is encouraging Low T makers to “work together on a clinical trial, but they are allowed to work separately if they so choose.”

Low T Makers asked to Police Themselves

Herein lies the rub. Why weren’t such studies done before Low T therapy was unleashed on the public? And how are companies with vested interests supposed to police themselves?  The design of any study can reach predetermined outcomes in various ways. Will Low T product makers kill a billion-dollar cash cow by designing studies that might possibly implicate their products in an unacceptably high risk of heart attacks, strokes, deaths?  Is it only cynicism to ask such questions?  Do corporations ever not act in their best interests first, in the best interests of their executives and shareholders, and in the interests of their customers second?  Or are corporations really people (as the Supreme Court ruled 5-4 with the duplicitously-named Citizen’s United case), entities who feel empathy for others, who bleed and cry and die like regular people?

FDA-approved Low T Products

A list of FDA-approved testosterone products can be found by searching “testosterone” at Drugs@FDA.The FDA urges health care professionals and patients to report side effects involving testosterone products to the FDA MedWatch program.

Testosterone Lawsuit

If you or someone you love took a Testosterone therapy product and suffered heart attack, stroke, blood clotting or worse, contact an experienced Testosterone Lawyer at Matthews & Associates for a free legal consultation.



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