Kristin J. Kelley, CardioExchange Staff

All posts by Kristin J. Kelley, CardioExchange Staff

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June 23rd, 2014

FDA: Risk for Venous Thromboembolism with All Testosterone Products

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

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

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

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 […]