FDA scrutinizing testosterone products

Candace Stuart | | Cardiovascular Business | Patient Care

The FDA is re-evaluating previously approved testosterone products after two studies suggested the testosterone treatments may increase the risk of stroke, MI and death.

The agency issued an alert to cardiologists, urologists and family practice physicians to inform them that it was investigating the potential safety risk of testosterone products. It cited two separate studies that reported safety signals.

Most recently, a cohort study of 55,593 men who initiated testosterone therapy found that older men and younger men with heart disease may be at increased risk.

The FDA instructed physicians to weigh the benefits and risk of testosterone treatments while it evaluates the studies and other data. Patients should not discontinue treatment without first talking with their physicians.

Patients and physicians are encouraged to report adverse events or side effects from use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Candace Stuart, Contributor

Related Content

Concomitant ablation surgery during heart operations boosts long-term survival
Cardiologist explores why colchicine failed to help heart attack patients
Bioresorbable BTK stent superior to ballon angioplasty at 2 years
Most heart failure patients miss out on guideline-recommended palliative care
Cardiologist behind EARLY TAVR explains how proactive treatment improves patient outcomes
FDA approves Medtronic’s new all-in-one mapping and ablation system for AFib

Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."