Pfizer Suspends Sales of Bextra (cont.)

Non-selective NSAIDs

Based upon the available data, FDA has concluded that an increased risk of CV events may be a class effect for NSAIDs. There are a number of non-selective NSAIDs currently approved for marketing in the United States. Long term controlled clinical trials have not been conducted with most of these NSAIDs. However, the available data suggests that use of these drugs may increase CV risk.

To further evaluate the potential for increased CV risk, all sponsors of non-selective NSAIDs will be asked to conduct and submit to FDA a comprehensive review and analysis of pertinent available controlled clinical trial databases.

In addition, FDA is requesting labeling changes for prescription and OTC non-selective NSAIDs. Because the use and labeling for the prescription products is different from those available without a prescription, they are addressed separately.

Prescription Non-Selective NSAIDs

Based on the available data, the FDA will request the manufacturers of all prescription products containing non-selective NSAIDs to revise their product labeling to include:

  • 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 to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs. The Medication Guide will 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 in an individual patient.

OTC Non-Selective NSAIDs

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

FDA will ask the manufacturers of all non-prescription 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 the package instructions unless otherwise advised by a physician, and
  • A warning about potential skin reactions.

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