April 7, 2005 - Like Vioxx, the anti-inflammatory painkiller Bextra has been withdrawn from the market. And a warning is being added to Celebrex and other prescription and over-the-counter anti-inflammatory drugs.
Details of the New Announcement
The FDA has concluded that the overall risk of Bextra outweighs the benefit. They have asked Pfizer, the manufacturer, to voluntarily withdraw the drug from the market.
In addition, the FDA is requesting that manufacturers of all prescription anti-inflammatory drugs, including Celebrex, include a boxed warning on their label. The boxed warning will highlight the potential risk of heart disease and stroke and the well-described, serious, and potentially life-threatening stomach ulcer bleeding associated with these drugs.
The FDA is also asking manufacturers of over-the-counter anti-inflammatory drugs to revise their labeling to include more specific information about the potential stomach ulcer, heart, and stroke risks.
The new information will include 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 in accordance with the package instructions unless otherwise advised by a doctor, and a warning about potential skin reactions.
Detailed Information on Cox-2 Inhibitors
Bextra is the only additional drug being removed from the market. Details of the risks and reasons for withdrawal include:
- Heart attack and stroke risks seen when used after heart artery bypass surgery.
- Reports of serious and potentially life-threatening skin reactions, including deaths. The risk of these serious skin reactions is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.
- Lack of any demonstrated advantages for Bextra compared with other anti-inflammatory drugs.
- Inadequate data on the heart safety of long-term use of Bextra.
The FDA says patients taking Bextra should contact their doctor to discuss discontinuing use and alternative treatments. Any decision about which drug to take to treat your symptoms should be made with your doctor.
Unlike Bextra, the FDA says the benefits of Celebrex outweigh the potential risks in properly selected and informed patients. The FDA has decided to allow Celebrex to remain and has asked Pfizer to take the actions listed below:
- Revise the Celebrex label to include a boxed warning about heart, stroke, and stomach ulcer bleeding risks.
- Include specific information on the data that show an increased risk of heart attacks and strokes with Celebrex.
- Encourage doctors to use the lowest effective dose for the shortest duration.
- Provide a medication guide at the time the drug is prescribed. It will inform patients of the heart, stroke, and stomach ulcer bleeding risk associated with anti-inflammatory drugs in general and Celebrex specifically. 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.
- Commit to conduct a long-term study of the safety of Celebrex compared to naproxen and other appropriate drugs.
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,
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.