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Painkiller Warnings Explained

Detailed Information on Cox-2 Inhibitors continued...

Vioxx was voluntarily removed from the market by Merck in September 2004. The FDA is going to carefully review any proposal from Merck to bring Vioxx back on the market.

Based on the available data, the FDA will request the manufacturers of all prescription products containing anti-inflammatory drugs to revise their product labeling to include:

  • A boxed warning regarding the potential for heart attacks and strokes and the serious, potentially life-threatening stomach ulcer bleeding associated with the use of this class of drugs.
  • A notice that these drugs should not be used in patients who have recently undergone heart bypass surgery.
  • A medication guide for patients to help make them aware of the potential for heart attacks, stroke, and stomach ulcer bleeding. The FDA says patients should discuss with their doctor the risks and benefits of using these drugs. In addition, patients should talk to their doctors about the importance of using the lowest effective dose for the shortest duration possible.

For a complete list of drugs affected by this FDA announcement, click here.

Over-the-Counter Anti-Inflammatory Drugs

The FDA says that data do not appear to show an increased risk of heart attacks and strokes with short-term, low-dose use of the anti-inflammatory drugs available over the counter.

The FDA will ask the makers of all nonprescription 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 heart attack, stroke, and stomach ulcer bleeding risks.
  • Instructions about which patients should seek the advice of a doctor before using these drugs.
  • Stronger reminders about limiting the dose and duration of treatment unless otherwise advised by a doctor. Previous recommendations have said not to take over-the-counter anti-inflammatory drugs for more than 10 days without seeing your doctor.
  • A warning about potential skin reactions.

Who is at higher risk when taking these drugs?

  • Patients who have had recent heart bypass surgery.
  • People with heart disease -- blockages in their heart arteries -- including people who have had chest pain or a heart attack.
  • People who have had a stroke or who currently have episodes known as TIA (transient ischemic attacks).
  • People with a history of stomach ulcers.

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