2014 Issues   /   Pharmacy

FDA Reviewing Low-T Therapy After Second Study Shows CV Issues

USM By U.S. Medicine
March 10, 2014

WASHINGTON — With a second study showing increased risk of cardiovascular events among men using testosterone replacement therapy, the Food and Drug Administration announced that it is reassessing the safety of those products. The agency said it is investigating the risk of stroke, heart attack and death in men taking FDA-approved products for low testosterone. “We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the agency reported in a safety alert. In January, a study appearing in PLOS ONE, an online open access journal, found that the risk of myocardial infarction following initiation of testosterone therapy is substantially increased in older men and in younger men with pre-existing diagnosed heart disease. A VA study late last year also found that testosterone replacement therapy increased risks of death, heart attack or ischemic stroke in veterans who had undergone coronary angiography and low serum testosterone levels. The FDA said it will continue to evaluate information from the studies and other available data and then communicate final conclusions and recommendations. Until then, it said, patients should not stop taking prescribed testosterone products without discussing the issue with healthcare professionals, but clinicians should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.

Related Articles

VA Hospitals First to Publicly Report Opioid Prescribing Rates

In January, the VA became the first hospital system in the United States to publicly post opioid prescribing rates.

Long-term Opioid Prescribing Declines in VHA, Bucking National Trend

Extended Prescribing Dropped from 9.5% in 2012 to 6.2% in 2016 By Brenda L. Mooney IOWA CITY, IA—Long-term prescribing of opioid painkillers is on the decline at the VA, in contrast to what appears to be happening outside of federal medicine.


U.S. Medicine Recommends


More From 2014 issues

2014 Issues

VA Slammed for Slow Action Against Officials Behind Wait-Time Scandal

Legislators: Only Four Senior Executives Removed by Mid-November

2014 Issues

VA Launches Largest Overhaul Ever as McDonald Pushes Reforms

WASHINGTON - New VA Secretary Robert McDonald continues to methodically tackle the issues that have caused a breakdown in efficient veteran care over the last few years, now pushing the agency to undertake the largest reorganization since its founding.

2014 Issues

VA’s IT Security Controls Cited for 15th Year in a Row

Controversial Scheduling System Will Be Replaced in 2015

2014 Issues

Study Offers New Statistics on How Many OEF/OIF Veterans Have PTSD

VA’s Consolidated Mail Outpatient Pharmacy (CMOP) in Charleston, SC. New legislation is seeking to increase clinician input into formulary decisionmaking. WASHINGTON — Legislation to prevent VA from outsourcing creation of its drug formulary and to... View Article

2014 Issues

Danger of Pneumonia Increases with Veterans’ Worsened Health Status

VA’s Consolidated Mail Outpatient Pharmacy (CMOP) in Charleston, SC. New legislation is seeking to increase clinician input into formulary decisionmaking. WASHINGTON — Legislation to prevent VA from outsourcing creation of its drug formulary and to... View Article

Facebook Comment

Subscribe to U.S. Medicine Print Magazine

U.S. Medicine is mailed free each month to physicians, pharmacists, nurse practitioners, physician assistants and administrators working for Veterans Affairs, Department of Defense and U.S. Public Health Service.

Subscribe Now

Receive Our Email Newsletter

Stay informed about federal medical news, clinical updates and reports on government topics for the federal healthcare professional.

Sign Up