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What is Bextra / Valdecoxib?
»
Why was Bextra withdrawn from the market?
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What are some of the
side effects of Bextra?
»
Why didn't the FDA
also recommend that Celebrex be withdrawn?
»
What types of patients are at the highest risk for dangerous Bextra side
effects?
»
What is Stevens Johnson Syndrome?
»
What should I do if I
am currently taking Bextra?
What is Bextra / Valdecoxib?
Bextra (valdecoxib) is in a class of drugs
called nonsteroidal anti-inflammatory drugs (NSAIDs). It is a Cox-2
inhibitor, meaning that Bextra works by inhibiting
cyclooxygenase enzymes that induce inflammation and pain in patients.
Bextra was introduced to the market with FDA
approval as a treatment for osteoarthritis, acute pain management, menstrual
symptoms, and relief from the symptoms of rheumatoid arthritis in both
adults and children.
Why was Bextra withdrawn from the market?
The pharmaceutical manufacturer Pfizer voluntarily removed Bextra from the
prescription drug market (April 7, 2005) following a request from the FDA
(Food & Drug Administration) that sales of the medication be stopped.
The FDA request was made following analysis of additional studies and
information that show an increased risk of cardiovascular events and
gastrointestinal bleeding associated with the use of Bextra. The FDA has
also cited serious and sometimes life threatening skin reactions, including
Stevens Johnson Syndrome.
| "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 |
What are some of the
side effects of Bextra?
In addition to the very serious, sometimes life threatening, side
effects of increased risk of heart attacks, cardiovascular events and
gastrointestinal bleeding, Bextra side effects may 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
Why didn't the FDA
also recommend that Celebrex be withdrawn?
The FDA has released the following statement regarding their NSAID
recommendations: "The Advisory
Committees were unanimous in their conclusion that an increased risk of CV
adverse events has been demonstrated for Celebrex (as for all the Cox-2
selective inhibitors) but strongly supported the continued marketing of the
drug. FDA has concluded, based on the available data, that the benefits of
Celebrex outweigh its potential risks in properly selected and informed
patients. This conclusion is based on our review of the available safety
data and the long-term controlled clinical trial comparisons of Celebrex to
non-selective NSAIDs. While it appears that Celebrex is associated with an
increased risk of serious CV adverse events, the available data do not
support a conclusion that Celebrex is significantly worse than the
non-selective NSAIDs. The NSAID class boxed warning regarding increased CV
and GI risks will be applied to Celebrex, and in addition the labeling will
include additional information as described in question 2 above that will
inform physicians and patients of the potential risks and allow for informed
prescribing decisions."
What types of patients are at the highest risk for dangerous Bextra side
effects?
Those at higher risk would 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.
What is Stevens Johnson Syndrome?
Stevens Johnson Syndrome (SJS) is a rare, life-threatening
reaction to medication – one of the most devastating of all adverse drug
reactions. SJS has been linked to the use of the painkiller Bextra,
manufactured by Pfizer, Inc., and Arava, manufactured by Aventis. Both drugs
are used to treat rheumatoid arthritis.
Stevens Johnson Syndrome is characterized by
inflammation of the mucous membranes of the mouth, throat, eyes, genital
tract and intestinal tract. Ulcers inside the mouth are the most common,
causing inflammation and irritation to the tongue, gums, and lips and can
extend into the throat. Affected individuals may also have skin lesions,
blisters and bleeding in the lips, eyes, mouth, nasal passage and genital
areas.
As SJS evolves, the skin literally sloughs
off in sheets. Patients are typically treated in a hospital’s burn unit. If
the skin lesions become infected, or the patient develops lesions in the
lungs, it can cause death.
What should I do if I
am 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 or any other dangerous prescription drug,
the manufacturer may have failed in its duty to design, make, inspect and
label the product appropriately.
Contact our experienced injury attorneys today for a
FREE claim evaluation. Contact Us Online, or call:
1(800)536-HELP | |
