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FDA Raises the Volume on Its Concern Over Testosterone Treatments — Physician’s First Watch

Medical News |
February 3, 2014

FDA Raises the Volume on Its Concern Over Testosterone Treatments

By Joe Elia

The FDA has heightened its posture of concern over studies showing higher cardiovascular risk in men taking testosterone.

On Friday, the agency issued a drug safety communication for cardiologists, urologists, and family practitioners: "We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies ... FDA is providing this alert while it continues to evaluate the information from these studies and other available data."

One study, published earlier in the week in PLoS One, showed a doubled risk for MI in older men on testosterone. The New York Times quoted this noncommittal FDA response: "We will communicate any new safety information on testosterone products when our reviews of all new information have been completed."

The other study, in the Nov. 6 JAMA, found a 30% higher risk for all-cause mortality, MI, or stroke among veterans who'd started testosterone therapy after undergoing coronary angiography.

Reader Comments (1)

humberto sanchez Physician, Hematology, Hospital Dr.Manuel Noriega Trigo

Tengo dos hijos de 29 y 31 años.ambos con Ca de Testiculo asociado al uso de tesoterona durante años.La usaron en gimnasios para desarrollar masa muscular::y varios casos comentados verbalmente con identica situacion:El servicio de patologia del hospital reporto un elevado numero de casos de TU testicular el pasado año

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