March 4, 2015

FDA Changes Testosterone Product Warnings, Limits Prescriptions

By Marilyn T.  McGoldrick, Esq.

Posted on Mar 4, 2015

The FDA has announced two important changes to the labeling of testosterone replacement (LowT) products. First, the makers of testosterone replacement medication must change the labels to make clear that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.” Prior to this directive, testosterone was widely advertised and prescribed to men with symptoms of aging such as loss of muscle mass, low sex drive, fatigue, and depressed mood. The FDA’s Drug Safety Communication says that: “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. for men with the typical symptoms of aging.”

The FDA has also strengthened the safety warnings on the label of testosterone products. Manufacturers must now add a warning about a possible increased risk of heart attacks, strokes, and other cardiovascular events in patients taking testosterone. Drugmakers must also conduct a long-term study about the safety of testosterone “to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.”

The new requirements track the recommendations made by the experts appointed last year to advise the FDA on these issues. The panel had voted 20-1 to limit prescription testosterone to a narrow list of actual medical conditions, and recommended further studies be undertaken on the risk of cardiovascular conditions such as heart attack and stroke.

Testosterone replacement has boomed over the past few years, fueled by millions of dollars in advertising. Over 2 million men take the supplements, and sales of testosterone replacement products are over $2 billion dollars and climbing.

This new FDA Drug Safety Communication only allows advertising or marketing of the drugs to persons whose low testosterone was caused by one of the recognized medical conditions originally approved for testosterone replacement, like pituitary tumors or genetic disorders. The FDA notes that the most common diagnosis for which testosterone therapy is currently prescribed is the not very specific ‚Äútesticular hypofunction, not elsewhere classified.”  The FDA is putting the brakes on the LowT industry. Most of the recent increase in prescriptions for testosterone replacement has gone to men aged 45 to 64 who are prescribed the drug for so-called LowT.

Thornton Law Firm is investigating claims for men who have suffered cardiovascular events while taking prescription testosterone replacement therapy. If you believe that you may have suffered a heart attack or stroke after taking testosterone replacement therapy, contact the LowT lawyers at Thornton Law Firm for a free, completely confidential consultation. Call us on our toll-free number 888-341-1405 to talk to one of our testosterone replacement lawyers, or tell us your story here. Lawsuits are subject to strict legal time limits so do not delay seeking legal advice if you believe you have a claim.

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