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European Health Agency NSAID Review Recommends No Changes

This article was originally published in The Tan Sheet

Executive Summary

The European Medicines Agency is not recommending changes in the use of non-steroidal anti-inflammatory drugs following an assessment of potential cardiovascular risks

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EMEA's Committee on Human Medicinal Products met Sept. 12-15 to review the link between NSAIDs and adverse events such as GI bleeding and skin rashes, yet does not expect to reach a conclusion until October. The committee "continued its assessment of the available data on the cardiovascular, gastro-intestinal and skin safety of non-selective non-steroidal anti-inflammatory drugs," the European Medicine Agency announces in a release Sept. 15. "It is expected that an overall view on the different safety aspects considered in this review will be reached during the Committee's October 2005 meeting." In August, the Committee announced that it did not recommend any changes to labeling information or advice given to patients and physicians about NSAID use (1"The Tan Sheet" Aug. 8, 2005, p. 6)...

UK Strengthens Addiction Warnings For Nonprescription Codeine Products

Warnings that long-term use of codeine and/or dihydrocodeine may lead to addiction will be added to product labeling for nonprescription analgesics that contain the ingredients, the Medicine & Healthcare products Regulatory Agency announced Aug. 15

EMEA Will Evaluate All NSAIDs In Search Of Potential “Class Effect”

The EU health authority will undertake its own review of all non-steroidal anti-inflammatory drugs in light of safety concerns surrounding COX-2 inhibitors

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