More Evidence Links Vioxx to Heart Attacks
September 14, 2005
(HealthDayNews) -- A major Canadian study solidifies evidence that the now-withdrawn arthritis drug Vioxx increases the risk of heart attack , and shows that higher doses are associated with a greater risk.
No similar increase in risk was found for Celebrex, another member of the cox-2 inhibitor family of drugs to which Vioxx belongs, said the report by researchers at McGill University in Montreal.
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 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 month s.
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WASHINGTON, D.C. - An expert on COX-2 inhibitors such as Vioxx had his invitation to participate in a drug safety panel rescinded by the U.S. Food and Drug Administration because of his criticism of that particular class of drugs.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
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.
MedWatch - BEXTRA Dear Healthcare Professional letter
October 16, 2004
2002 Safety Alert - BEXTRA (valdecoxib tablets). ... Please see the revised full prescribing information for BEXTRA enclosed with this letter.
Pfizer Warns of Bextra Risks - Safety of All COX-2 Inhibitors Questioned
October 16, 2004
Pfizer has issued a warning that its popular pain killer Bextra could increase the risk of heart attack or stroke in patients who have undergone heart bypass surgery.
Pfizer Links Bextra, Some Heart Problems
October 15, 2004 12:42:28 PM PDT , Reuters
Pfizer Inc. (NYSE:PFE - news) 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 an increased risk of stroke and heart attack.
Bextra Consumer Information : Bextra®. Brand Name: Bextra®. Active Ingredient: valdecoxib. Strength(s): 10 mg and 20 mg. ... What is Bextra used for? Bextra is used to relieve...
New worries tarnish arthritis drugs - Experts debate whether entire class is problematic Thursday, November 11, 2004 Posted: 10:04 AM EST (1504 GMT)
In September, Merck & Co. yanked Vioxx from the market when a trial showed that long-term use of the painkiller nearly doubled the risk of heart attack and stroke.
This week, researchers said a preliminary study indicated that Bextra -- another painkiller in the same class -- also more than doubled the risk of heart attacks and strokes among patients with heart disease.
Bextra - Pfizer Calls New Bextra Study Unsubstantiated
Pfizer has called a new study about Bextra which cites an increased heart risk, reported at an American Heart Association meeting and in the New York Times, "unsubstantiated".
American Dental Assocation reports on a Bextra lawsuit over Pharamica's use of outside 'research groups' to circumvent the FDA.
FDA Patient Safety News: Show #12, February 2003 : New Warnings on Bextra Label FDA Patient Safety News: Show #12, February 2003. FDA and Pharmacia are advising health care professionals... |
