September 19, 2014

Experts Recommend FDA Limit “Low T” Testosterone Drug Claims

Posted by Marilyn McGoldrick on Sep 19, 2014 12:11:00 PM

A panel of experts appointed to advise the FDA voted 20-1 this week to recommend the FDA warn consumers that testosterone treatments have not been shown to reverse common problems of aging like low libido, muscle loss or energy levels. Testosterone drug makers have been advertising that testosterone will improve the condition they have named “Low T”, but the panel says that language should be added to the drug labels to make clear that there is little or no scientific evidence that this is the case.

Testosterone replacement has become a booming business over the past five years. Commercials and advertisements have flooded popular media. As a result, over 4.8 million prescriptions were written in 2013 alone according to drug data firm IMS-Health. It is estimated that over 2 million men take the supplements. The FDA advisory panel vote would only allow advertising or marketing of the drugs to persons whose low testosterone was caused by one of the medical conditions originally approved for testosterone replacement, like pituitary tumors or genetic disorders.

In contrast to the limited marketing recommended by the panel, 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, a condition not linked to pituitary or genetic disorders. Further, the safety of testosterone replacement is in question, as recent research has pointed to a possible link to heart attacks and strokes. The panel recommended that the FDA undertake further studies of those possible serious cardiovascular side effects.

The FDA also announced that the same panel rejected a new oral testosterone-replacement called Rextoro – generic name testosterone undecanoate – made by privately-held Clarus Therapeutics Inc. The panel held that the benefits didn’t outweigh the risks of Rextoro. The FDA staff analysis found that it wasn’t safe enough, and doctors on the panel were concerned that the oral drug was likely to be used more by men who weren’t taking it for an approved medical reason.

If you believe you  have experienced a serious cardiovascular side effect like heart attack or stroke after taking testosterone replacement therapy, contact the LowT lawyers at Thornton Law firm for a free, confidential legal consultation. Tell us your story here or call us toll-free at 888-341-1405 to talk to one of our testosterone replacement lawyers. Time limits for filing all legal claims are short; do not delay seeking legal advice.

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