Bextra Gets New Warning On Label
NOTE: April 7, 2005, Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the with the FDA. For more information, please read the
FDA press release.
Related MedicineNet Medication
Links
Related MedicineNet Disease Links
Bextra Label Updated with Boxed Warning Concerning Severe Skin
Reactions and Warning Regarding Cardiovascular Risk
The Food and Drug Administration (FDA) announced today important new
information on side effects associated with the use of Bextra, a COX-2 selective
non-steroidal anti-inflammatory drug (NSAID) which is indicated for the
treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual
pain). A "boxed" warning, strengthening previous warnings about the risk of
life-threatening skin reactions and a new bolded warning contraindicating the
use of Bextra in patients undergoing coronary artery bypass graft (CABG) surgery
will be added to the label.
In addition, the FDA will also seek input from the public and from outside
experts on the appropriate uses for Bextra and other NSAIDs at a
previously-announced Advisory Committee meeting, to be held early in 2005.
Boxed and bolded warnings provide healthcare professionals and patients with
important information on drugs that may be associated with serious side effects
in a way that maximizes the drug's benefits and minimizes its risks.
Serious Skin Reactions The new boxed warning in the label states that
patients taking Bextra have reported serious, potentially fatal skin reactions,
including Steven-Johnson Syndrome and toxic epidermal necrolysis. These skin
reactions are most likely to occur in the first 2 weeks of treatment, but can
occur any time during therapy. In a few cases, these reactions have resulted in
death. The labeling advises doctors that Bextra should be discontinued at the
first appearance of a skin rash, mucosal lesions (such as sores on the inside of
the mouth), or any other sign of allergic reactions. The new boxed warning also
states that Bextra contains sulfa, and patients with a history of allergic
reactions to sulfa may be at a greater risk of skin reactions.
As of November 2004, FDA had received reports of a total of 87 cases in the
United States of severe skin reactions in association with Bextra, including
Stevens-Johnson Syndrome and toxic epidermal necrolysis. Twenty of the 87 cases
involved patients with a known allergy to sulfa. Of these 87 cases, 36
hospitalizations were reported, including 4 deaths. Other Cox-2 selective
inhibitors and traditional NSAIDs such as naproxen and ibuprofen also have a
risk for these rare, serious skin reactions, but the reported rate of these
serious side effects appears to be greater for Bextra than for other COX-2
agents.
Cardiovascular Risks In addition to highlighting serious skin reactions, the
strengthened label warnings also highlight new data about cardiovascular risks.
A recently-completed study conducted by Pfizer, which included over 1,500
patients treated after CABG, showed an increased cardiovascular risk in patients
treated with Bextra compared to placebo. Observed cardiovascular events included
thromboembolic events such as myocardial infarction (heart attack),
cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the
leg), and pulmonary embolism (blood clot in the lung).
Pfizer submitted the final report of the new CABG study to FDA on November 5,
2004. The report confirms the risk of the intravenous form (about 2 percent of
patients had such an adverse event) and also shows that oral Bextra is
associated with a lower, but some, risk (about 1 percent of patients)
immediately following CABG surgery--a very specific medical setting. In the
placebo group, about 0.5 percent of patients had an adverse cardiovascular
event. Bextra is not approved for use in the treatment of postoperative pain of
any type; however, FDA believes that these new findings should be made available
to healthcare professionals and patients, and the bolded warning specifically
contraindicates Bextra for treatment of pain immediately following CABG.
FDA urges health care providers and patients to report adverse event
information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax
(1-800-FDA-0178), or by the Internet http://www.fda.gov/medwatch/index.html .
Reports can also be made directly to Pfizer, Inc., Peapack, N.J. at
1-800-323-4204.
Source: FDA Talk Paper, T04-56, December 9, 2004
Last Editorial Review: 4/7/2005
Medication RSS