An advisory committee for the U.S. Food and Drug Administration has voted to reject a new oral testosterone drug called Rextoro, saying that the drug is â€śineffective.â€ť
Testosterone replacement therapy (TRT) is a controversial hormone treatment used to help men produce more testosterone naturally. Traditionally, testosterone treatments are applied externally, through gels, lotions and even nasal sprays.
What Are the Dangers of Testosterone Gel?
Some of the biggest problems with topical testosterone are skin reactions (like rashes, itching or swelling) and secondhand exposure. Patients can leave trace amounts on door handles or countertops, which can expose women and children to high doses of testosterone.
Clarus Therapeutics Inc. submitted an application for Rextoro back in January, saying that the “easy-to-swallow softgel capsulesâ€ť were more convenient than gels or ointments. The drug company also believed that the pills were less likely to cause skin reactions or accidental exposure.
Why Wasnâ€™t This Drug Approved?
Despite the advantages of offering the drug in pill form, the FDAâ€™s advisory committee voted against widely distributing the drug, because there was not enough evidence to support Rextoroâ€™s effectiveness.
The panel voted 18-3 that the overall benefit/risk profile of Rextoro was not acceptable for testosterone replacement therapy. The decision comes after the FDA decided to crackdown on all testosterone drugs following reports of heart attack, stroke and blood clot risks among men.
Do I Need Testosterone Replacement Therapy?
In light of the health risks, the panel recommended that doctors stop prescribing TRT to all men suffering from low T. Instead, they advised healthcare professionals to only prescribe testosterone drugs for men suffering from medical conditions that affect their testicles, like prostate cancer, hypogonadism or tumors.
I Need an Attorney Who Handles Testosterone Cases
Drug companies are willing to market testosterone therapy to every man with low T to boost sales, despite the drugâ€™s documented health risks. If you or a loved one has suffered because a doctor or drug company did not let you know the risks, a licensed attorney could help you get justice.
[Did You Know:Â The first testosterone skin patch was approved in 1995.]
Proffitt & Cox, LLPÂ â€“Â Columbia Injury Lawyer