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FDA Law Weekly

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Adverse Drug Reactions



Research from Tufts University, Molecular Cardiology Research Institute has provided new data on adverse drug reactions



March 15th, 2007

Research findings, "Safety of lovastatin/extended release niacin compared with lovastatin alone, atorvastatin alone, pravastatin alone, and simvastatin alone (from the United States Food and Drug Administration adverse event reporting system)," are discussed in a new report. According to a study from the United States, "Recent national guidelines support combination drug therapy targeting multiple lipid abnormalities. Current drug labeling warns of an increased risk of adverse events with statin and niacin combinations."

"These recommendations have been based solely on case reports. We compared the rates of adverse event reports (AERs) received by the United States Food...


Source: FDA Law Weekly (2007-03-15)

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