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FDA Panel Calls for More Research on Testosterone Therapy


Loyola University Health System (LUHS)

September 18, 2014

Advisors to the U.S. Food and Drug Administration reported yesterday that additional research is needed to determine if testosterone therapy causes an increased risk for heart attacks and stroke. Advisors also recommended that the FDA develop language in product labels to restrict the intended use of the drugs, which have been widely prescribed in recent years.

Loyola University Health System (LUHS) endocrinologist Norma Lopez, MD, believes testosterone therapy should be prescribed on an individual basis after weighing the risks and benefits.

"Testosterone levels and other health issues should be taken into consideration when determining if a patient is a good candidate for this therapy," said Dr. Lopez, assistant professor of endocrinology, Loyola University Chicago Stritch School of Medicine. "I commend the FDA advisory panel for raising awareness about the use of testosterone therapy and the potential risks associated with it."

Dr. Lopez reported that more men use testosterone therapy now than in the past. The agency said in its briefing documents for the hearing that it had seen a 65 percent increase in sales of testosterone therapy between 2009 and 2013.

"There is more pressure placed on physicians now to prescribe testosterone therapy even when blood levels of the hormone may be borderline," Dr. Lopez said. "Like any medication, testosterone therapy comes with risks, so we need to look closely at who is receiving this therapy and if it is absolutely necessary."

Approximately 5 million men have low testosterone levels, which can affect a man's sex drive, physical features and mood. Signs of low testosterone include:

Fatigue or decreased energy
Reduced sex drive
Sexual dysfunction
Depressed mood
Increased body fat
Reduced muscle mass and strength
Decreased bone strength
Loss of body hair
Hot flashes
Dr. Lopez encourages men to speak with their doctor and have their blood tested to determine if they are good candidates for testosterone therapy.

Loyola University Health System (LUHS) is a member of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. The medical center campus is conveniently located in Maywood, 13 miles west of the Chicago Loop and 8 miles east of Oak Brook, Ill. The heart of the medical center campus is a 559-licensed-bed hospital that houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children's Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as the LUC Stritch School of Medicine, the LUC Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola's Gottlieb campus in Melrose Park includes the 255-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.

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