Posts Tagged ‘FDA warning’

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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 […]


April 20th, 2012

Aliskiren (Tekturna) Gets New Warning and Contraindication from FDA

The FDA has issued new warnings about antihypertensive drugs containing the direct renin inhibitor aliskiren (including Tekturna, Amturnide, Takamio, and Valturna) when used in combination with ACE inhibitors or angiotensin-receptor blockers (ARBs). The FDA now states that these drug combinations are contraindicated in patients with diabetes, and it is adding a new warning to avoid […]


December 27th, 2011

Clopidogrel Testing Comes Under Fire

The phenomenon of clopidogrel resistance has been much discussed, but no consensus has emerged about the best, or any, response to the problem. Now a review published in JAMA finds no clinically relevant relationship between the CYP2C19 genotype  and cardiovascular events. Michael Holmes and colleagues performed a meta-analysis of 32 studies involving CYP 2C19 genotyping and more than […]