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Tag Archive | "cardiovascular"

FDA warning on Multaq and Increased Risk of Death

Thursday, December 22, 2011

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U.S. Food and Drug Administration has completed a safety review of Multaq (generic name dronedarone).  According to this review, in patients with permanent atrial fibrillation (AF),  Multaq increased the risk of serious cardiovascular events, including death. The  data was obtained from ATHENA and PALLAS clinical trials.  New information and recommendations are being provided by FDA for […]

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Tiotropium risk of stroke and reports of cardiovascular adverse outcomes

Tuesday, November 18, 2008

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Tiotropium (marketed as Spiriva HandiHaler) FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed […]

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