NSAID safety issues

• A boxed warning regarding the potential serious adverse CV events and the serious, and potentially life-threatening GI adverse events associated with the use of this class of drugs. 
• A contraindication for use in patients who have recently undergone coronary artery bypass surgery. 
• A Medication Guide for patients regarding the potential for CV and GI adverse events associated with the use of this class of drugs. The Medication Guide will be required to be given to patients at the time each prescription is dispensed. The Medication Guide will also inform patients of the need to discuss with their doctor the risks and benefits of using NSAIDs and the importance of using the lowest effective dose for the shortest duration possible if treatment with an NSAID is warranted for an individual patient. (Related: How to lower back pain)
• Patients who are taking a prescription non-selective NSAID should discuss questions or concerns about this new information with their physician. 

OTC Non-Selective NSAIDs 

The available data do not suggest an increased risk of serious CV events for the short-term, low-dose use of the NSAIDs available over the counter. FDA will allow these products to remain on the market, but will request changes to the label to better inform consumers regarding the safe use of these products.

FDA will ask manufacturers of all OTC products containing ibuprofen (Motrin, Advil, Ibu-Tab 200, Medipren, Cap-Profen, Tab-Profen, Profen, Ibuprohm), naproxen (Aleve), and ketoprofen (Orudis, Actron) to revise their labeling to include: 

• More specific information about the potential CV and GI risks, 
• Instructions about which patients should seek the advice of a physician before using these drugs, 
• Stronger reminders about limiting the dose and duration of treatment in accordance with package instructions, unless otherwise advised by a physician, and 
• A warning about potential skin reactions.

Patients who are taking an OTC NSAID should carefully follow the labeled directions, particularly with regard to dose and duration of use, and should contact their physician regarding any questions or concerns they may have about this new information.

Note: Aspirin is a nonselective NSAID. However, aspirin is also a platelet inhibitor and has been shown in clinical trials to reduce the risk of CV events. Patients taking aspirin to prevent CV events should NOT stop taking it, unless specifically advised to do so by their physician. 

Recommended links:  Vioxx recall, Bextra recall, Celebrex black box warning, 

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