Kristin J. Kelley, CardioExchange Staff
June 23rd, 2014
FDA: Risk for Venous Thromboembolism with All Testosterone Products
Kristin J. Kelley, CardioExchange Staff
The FDA is requiring an expanded label change to all approved testosterone products to warn of the increased risk for venous thromboembolism. Labels currently address the risk for clots associated with polycythemia caused by testosterone treatment. The action follows reports of blood clots in testosterone users unrelated to polycythemia. The agency says the warning is not […]
December 21st, 2012
Dabigatran Shouldn’t Be Used in Patients with Mechanical Heart Valves
Kristin J. Kelley, CardioExchange Staff
Dabigatran (Pradaxa) should not be prescribed to prevent blood clots or stroke in patients with mechanical heart valves, the FDA warned. The warning follows the termination of a European clinical trial in which patients taking dabigatran had more frequent thromboembolic events than those on warfarin. Dabigatran patients also experienced more bleeding after valve surgery. Patients with mechanical […]
December 7th, 2012
Heparin Labels Will Be Revised to Reduce Dosing Miscalculations
Kristin J. Kelley, CardioExchange Staff
Heparin manufacturers will now be required to state the total drug strength of the entire container on their labels, the FDA announced on Thursday. The revisions, proposed by the United States Pharmacopeia (USP) in order to avoid medication errors caused by dosing miscalculations, will take effect on May 1, 2013. The new labels for heparin lock […]
July 12th, 2012
FDA Issues Class I Recall of Cardiovascular Diagnostic Tests
Kristin J. Kelley, CardioExchange Staff
The FDA announced on Wednesday a Class I recall of several lots of cardiovascular diagnostic tests aiding in the triage of heart failure, MI, and pulmonary embolism. According to the agency, the affected products do not provide the precision described in the package insert, which could lead to potentially fatal false-positive and false-negative test results. The […]
NEJM Journal Watch — Recent Cardiology Articles- Sex-Based Disparity in CABG Outcomes: Are We Moving Toward Parity?
- Can Genetic and Social Risk Scores Improve Cardiac Risk Prediction?
- Extensive Ablation vs. Pulmonary Vein Isolation in Persistent Atrial Fibrillation
- Can a Novel Stent Design Improve Long-Term Outcomes of Percutaneous Coronary Intervention?
- Are Angiographically-Derived Coronary Physiology Measurements Ready for Use in the Cath Lab?