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First drug safety report

This article was originally published in The Tan Sheet

Executive Summary

FDA posts its first quarterly report of drugs under investigation for potential safety issues based on adverse event reports. The report meets a provision of the Food and Drug Administration Amendments Act and is intended to increase transparent communication. Published Sept. 5, the inaugural report lists 20 drugs and their potential adverse effects that FDA identified between January and March. For example, the list includes duloxetin (Eli Lilly's Cymbalta) for possible urinary retention. While the first report lists only prescription drugs, future reports could include OTC drugs. FDA stresses consumers should not stop taking a drug just because it appears on the list. The agency says its communication is preliminary and an investigation may determine an adverse event is not drug-related

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