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Posts Tagged ‘celebrex’

Experts Advise Users to Follow Directions On Painkiller Label

Wednesday, August 1st, 2007

By Marilynn Marchione, THE ASSOCIATED PRESS
Getting a headache trying to choose a painkiller?
The government’s advice is to take the lowest possible dose for the shortest possible time, and talk with your doctor about what’s best for you.
No medicine is without risk, but nonprescription pain pills appear safe when taken at the suggested dose [...]

Bextra Recall a Sign of Tougher Drug Safety?

Monday, April 11th, 2005

The FDA has been the object of great criticism in recent months. Some influential members of Congress, including Senate Finance Committee Chairman Charles E. Grassley (R-Iowa), have been pushing for a more independent drug safety office within the FDA.
The FDA, according to some critics, has been ineffective in protecting public safety from dangerous drugs [...]

Bextra Lawsuits Filed Against Pfizer in New York

Monday, April 11th, 2005

Source: PR Newswire
Three Bextra lawsuits were filed against Pfizer Inc. on behalf of three individuals who allegedly were injured by the pain relief drug, Bextra, the Philadelphia law firm Kline & Specter, P.C. announced Monday in a statement.
Two of the plaintiffs suffered heart attacks and one sustained a stroke after taking Bextra, attorneys for the [...]

Celebrex to Include Boxed Warning, FDA Says

Friday, April 8th, 2005

Source: U.S. Food and Drug Administration
Published: April 08, 2005
Celebrex, a pain relief drug from Pfizer Inc., will include a boxed warning, highlighting the potential for increased risk of heart problems and the serious, potential life-threatening gastrointestinal (GI) bleeding associated with its use, the Food and Drug Administration said Thursday in a statement.
The agency [...]

FDA Goes Against Recommendations of its Advisory Panel and Bans Bextra

Thursday, April 7th, 2005

After six months of questions regarding the COX-2 inhibitor class of drugs, including Merck & Co.’s Vioxx and Pfizer Inc.’s Celebrex and Bextra, the FDA has asked Pfizer to remove Bextra from the market.
Though Pfizer said it disagreed with the FDA’s request to withdraw Bextra, the company has stopped sales of its $1.3 billion [...]

COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Thursday, April 7th, 2005

The Food and Drug Administration (FDA) has asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market. FDA is also asking manufacturers of all marketed prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for [...]

Health Advocates Call for Reform of FDA Advisory Committees

Monday, March 21st, 2005

Health Advocates Call for Reform of FDA Advisory Committees
Source: Center for Science in the Public Interest

“Stop placing scientists with direct financial conflicts of interest” on Food and Drug Administration advisory committees, health advocates wrote in a letter to Acting FDA Commissioner Lester Crawford.
In the letter dated March 10, 2005, the groups said the agency [...]

Celebrex, Other COX-2 Drugs Being Cast Off

Wednesday, March 9th, 2005

According to a Spine-health.com poll, nearly two-thirds of patients who were taking a COX-2 inhibitor, which includes Celebrex, Bextra and Vioxx, prior to the September 2004 Vioxx recall and Celebrex and Bextra adverse cardiovascular studies that followed in the months after are no longer taking the medications.
The poll included 375 back pain patients who [...]

New Celebrex Trial Will be Conducted

Wednesday, February 23rd, 2005

FDA advisers unanimously voted that Celebrex increases the risk of heart attack and stroke. The advisers recommended the arthritis medicine carry the FDA’s most severe warning, known as a black box.
In response to the FDA panel meeting, Pfizer Inc. said it will no longer attempt to prove its drug has a heart benefit and [...]

FDA Panel Rules Celebrex Increases Heart Risks

Friday, February 18th, 2005

A committee of doctors and scientists has unanimously voted that Pfizer Inc.’s biggest selling prescription arthritis drug Celebrex significantly raises the risk of heart attacks and stroke.
Chairman of the panel, Alastair Wood, said four or five studies have shown significant cardiovascular hazards among COX-2 inhibitors, the class of drug Celebrex belongs to. Last September, [...]