Pfizer Suspends Bextra Sales in U.S.,
Europe
04/07/2005
NEW YORK (Reuters) - Pfizer Inc. on
Thursday suspended sales of its arthritis
drug Bextra on requests by U.S. and
European regulators, who said the risks of
potentially fatal side effects outweigh the
benefits.
The FDA said it singled out Bextra for
suspension because it gives no added
advantage as a painkiller and can cause a
potentially life-threatening skin condition
called Stevens-Johnson syndrome
Pfizer arthritis ads 'misleading': FDA.
1/12/2005
The U.S. Food and Drug Administration
has warned Pfizer in a letter that its
ads for arthritis drugs Celebrex and
Bextra are misleading.
The FDA
said in a letter dated Jan. 10 and
released on Wednesday that Pfizer (PFE:
news,
chart,
profile) failed to disclose
information on risks in different
advertising campaigns and made
"unsubstantiated effectiveness claims"
in its ads. The letter alleged Pfizer
violated provisions of the U.S. Food,
Drug and Cosmetic Act.
Doctors Say Avoid Pfizer's Bextra -Medical
Journal
12/27/2004
a Yahoo News Report stated that Doctors
recommend avoiding Pfizer's Bextra, just as
a large study found the drug maker's sister
drug, Celebrex, doubled risk of heart
attacks.
Shades of the Vioxx Case for Bextra
11/23/2004
WASHINGTON, New York Times
The U.S. Food and Drug Administration is facing the same questions and problems with Bextra today as it did with Vioxx three years ago, and facing the same lack of clarity when striking a balance.
Pfizer Hit With Bextra Lawsuit
Nov 16, 2004, TheStreet.com, NY
Pfizer was hit by a lawsuit alleging its painkiller Bextra was responsible for the death of a 46-year-old New Jersey man who used the drug for nine months.
Drug Expert Concerned About Bextra & COX-2 Drugs (registration required)
11/13/2004, Washington Post
WASHINGTON, D.C. – An expert on COX-2 inhibitors such as Vioxx had his invitation to participate in a drug safety panel rescinded by the U.S. Food and Drug Administration because of
his criticism of that particular class of drugs.Study Links Bextra to Heart Attacks
11/10/2004, Herald Tribune
In a Wake Forest
University study, the rate of heart attacks and strokes in patients given Pfizer’s painkiller Bextra was more than double that of those given placebos.
New Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks
November 10, 2004, Southwest Florida Herald Tribune (and
New York Times, Subscription Required)
By GARDINER HARRIS, The incidence of heart attacks and strokes among
patients given Pfizer's painkiller Bextra was more than double that of those
given placebos, according to preliminary results of a study presented
yesterday at the American Heart Association meeting in New Orleans.
Pfizer Says FDA Warning Likely For Bextra
November 4, 2004, Forbes.com
According to Pfizer, Bextra can cause a rare but sometimes
life-threatening drug reaction called Stevens-Johnson Syndrome in which
the skin, mouth, and eyes can become horribly blistered.
EMEA to review COX-2 inhibitors
October 22, 2004, European Medicines Agency
Following the worldwide withdrawal of Vioxx (rofecoxib), the
European Medicines Agency (EMEA) has been asked by the European
Commission, as a precautionary measure, to conduct a review of COX-2
inhibitor medicines.
Pfizer Says Bextra, Heart Problems Linked
October 15, 2004
Pfizer Inc. on Friday said
two small clinical trials showed heart bypass surgery patients
taking Bextra, an anti-inflammatory in the same class as the
recently withdrawn drug Vioxx, had a higher risk of stroke and heart
attack.
The company also updated its warning that Bextra can cause a rare,
but sometimes fatal, skin disorder called Stevens-Johnson syndrome
to note that cases of the condition are being seen more often with
Bextra than with other drugs in the same class.
More tests to be conducted on arthritis drug
In addition, Bextra has been studied in several surgical settings.
In studies in general surgery, Bextra in combination with the
investigational drug parecoxib showed no increased risk of
cardiovascular thromboembolic events. However, in two trials in a
high-risk surgery known as coronary artery bypass graft, an increase
in cardiovascular events was observed in patients receiving Bextra
alone or in combination with parecoxib, the company said.
Pfizer shares slammed by Bextra update
Pfizer shares slumped Friday after the Dow component said it would
conduct additional studies on its Bextra drug treatment for
arthritis pain to confirm its cardiovascular safety for patients.
Update 2: Pfizer to Test Safety of Pain-Drug Bextra
Pfizer Inc. said Friday it will conduct long-term cardiovascular
safety tests on its pain drug Bextra in light of Merck & Co. pulling
Vioxx, a drug in the same category.
After the announcement, Pfizer shares dropped $1.23, or 4.2 percent,
to $27.85 in morning trading on the New York Stock Exchange.
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