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Bextra is a prescription pain management drug usually prescribed for
patients suffering with arthritis, acute pain management, and severe
menstrual symptoms. Bextra, a pharmaceutical medication, is in a class of
drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Other NSAIDs
including Vioxx and Celebrex.
An FDA (Food & Drug Administration) advisory panel has been studying the
drug safety and risky side effects associated with Bextra, Vioxx and
Celebrex. The latest FDA recommendations regarding the sale and labeling of
NSAIDs can be found here:
http://www.fda.gov/cder/drug/infopage/COX2/default.htm
The FDA's recommendations include a request that pharmaceutical manufacturer
Pfizer halt the sale of Bextra (April 7, 2005). The release states that the
health risks associated with Bextra outweigh the drug's benefits.
| "We have concluded that, from a public
health perspective, we must assume that Bextra has an increased risk of
CV events with long-term use. This conclusion is strongly supported by
the significant increase in CV risk seen in those patients who had just
undergone heart surgery and the fact that other COX-2 selective NSAIDs
have demonstrated such increased CV risk in long-term studies." - FDA.gov |
FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib)
label. FDA is asking manufacturers of all other prescription NSAIDs to
revise their labels to include the same boxed warning highlighting the
potential for increased risk of cardiovascular (CV) events and
gastrointestinal (GI) bleeding associated with their use. Manufacturers of
Celebrex and all other prescription NSAIDs will be asked to revise their
labeling to include 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.
Bextra was first approved by the FDA in November, 2001. Since then it is
estimated that over 7 million patients worldwide have taken Bextra, and that
12.9 million prescriptions were written last year alone. This resulted in
approximately $1.5 billion in Bextra sales for Pfizer just last year.
Since the approval of Bextra, all NSAIDs and COX-2 inhibitors have come
under the scrutiny of the medical community. Several studies have shown an
increased risk of heart attacks, strokes and other cardiovascular events in
patients taking Bextra. Additionally, the FDA has cited an increased risk
for gastrointestinal bleeding and life threatening skin reactions, including
Stevens Johnson Syndrome (SJS).
Bextra side effects sometimes include:
- Abdominal pain, tenderness, or discomfort
- Bloody, black, or tarry stools
- Nausea or heartburn
- Bloody vomit
- Unexplained weight gain
- Swelling or water retention
- Unusual fatigue or lethargy
- Yellowing of the skin or eyes
- Flu-like symptoms
- Unusual bruising or bleeding
Studies have indicated
that those at higher risk for dangerous Bextra side effects include patients immediately
post-operative from cardiovascular bypass surgery (CABG) and people who have
coronary artery disease (people who have known angina or who have had a
heart attack), people who have cerebrovascular disease (people who have had
a stroke or who currently have episodes known as TIA (transient ischemic
attacks)), and people with a history of stomach ulcers.
If you are currently taking Bextra,
you should immediately contact your doctor to discuss alternative
medication. Any decision about which drug product to take to treat your
symptoms should be made in consultation with your physician based on an
assessment of your specific treatment needs.
If you have been injured by Bextra
the manufacturer may have failed in its duty to design, make, inspect and
label the product appropriately.
Brown & Crouppen has been building a reputation for success with
personal injury clients for almost 25 years. Today, we are one of
mid-America’s largest personal injury law firms with over 70 legal
professionals and five offices throughout Missouri and Illinois. Brown &
Crouppen has thrived because of our shared commitment to deliver the best
possible service to clients throughout Missouri and the United States. A
large area of our concentration is dangerous drug litigation involving
manufacturers and suppliers of unsafe drugs and products.
Contact our experienced injury attorneys today for a
FREE claim evaluation. Contact Us Online, or call:
1(800)536-HELP | |
