Posts Tagged ‘safety’

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October 6th, 2014

Selections from Richard Lehman’s Literature Review: October 6th

This week’s topics include medical device safety and effectiveness, familial hypercholesterolemia, and more.


January 14th, 2014

All Lots of Liptruzet In U.S. Recalled Over Packaging Defect

Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the U.S. The company said the recall was due to a packaging defect that could potentially allow air and moisture to affect the quality of the drug, although “the likelihood of the packaging defects decreasing the […]


January 3rd, 2014

FDA Plans New Safety Assessment of Dabigatran (Pradaxa)

Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the U.S. in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. On December 30 the FDA posted a request for public comment on a proposed […]