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FDA Information

Etodolac has been approved by the Food and Drug Administration in 1996.

On April 7th 2005, the FDA announced that they are asking manufacturers of all prescription nonsteroidal anti-inflammatory drugs (NSAIDs) to revise the drug labeling (package insert) to include a ''boxed'' or serious warning about the potential for increased risk of cardiovascular events (including heart attack and stroke) and serious and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. This information also state that patients who have just had heart surgery should not take these medications.

 

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