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By Michael Smith, MD
WebMD Medical News
Reviewed By Brunilda Nazario, MD
February 22, 2005
After three grueling days of meetings, an FDA expert panel released its recommendations last week regarding Vioxx and other so-called Cox-2 inhibitors, such as Celebrex and Bextra. They also had a few things to say about the older anti-inflammatory pain relievers. In order to help you sift through this confusing and controversial topic, WebMD's doctors put together this list of 10 things you need to know about pain relievers.
Among the arthritis drugs known as Cox-2 inhibitors, Vioxx has been most strongly linked to heart attacks and strokes. Celebrex at the most common dose of 200 mg per day has not been linked to an increase in heart attacks and strokes. Of all the Cox-2 inhibitors, the least amount is known about Bextra because fewer studies have been done evaluating its potential risks. An FDA warning about Bextra applies only to patients undergoing heart bypass surgery. Cox-2 inhibitors don't treat pain any better than older anti-inflammatory drugs like ibuprofen and naproxen.
Most people on Cox-2 inhibitors don't need them and can use an older anti-inflammatory drug. Cox-2 drugs are meant for people who have had a stomach ulcer or are at high risk of stomach bleeding, such as people on the blood thinner Coumadin. Acetaminophen (Tylenol) is not an anti-inflammatory drug and has never been linked to heart attacks and strokes.
Almost all anti-inflammatory drugs, including the Cox-2 inhibitors and the older drugs, carry some increased risk of heart attack and stroke. Although one report linked naproxen (brand names Aleve and Naprosyn) to an increase in heart attacks, experts feel that was unjustified and unnecessarily scared the public. Naproxen may actually be the one anti-inflammatory drug that may lower heart attack risk other than aspirin.
The FDA expert panel does not have the final say. The official FDA decision is expected to be announced in the next few weeks. The FDA typically follows the suggestions of its expert panels.
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SOURCES: WebMD Medical News: "Despite Risks, Pain Relievers Given OK." WebMD Medical News: "Celebrex Linked to Heart Attacks." WebMD Medical News: "Heart Warning Added to Bextra Label." WebMD Medical News: "Vioxx, Celebrex Were Overused, Study Shows." WebMD Medical News: "Naproxen Warning Unjustified, Say
FDA Experts.
Posted April 2005 | Permanent Link
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