Celebrex

What Is Celebrex?

Celebrex, a non-steroid anti-inflammatory drug used to treat rheumatoid arthritis and osteoarthritis, and has been linked to an increased risk of serious adverse cardiovascular effects.

On December 17, the FDA asked Pfizer to voluntarily suspend direct-to-consumer advertising on Celebrex during the time the FDA is obtaining and evaluating the new and conflicting scientific data on adverse effects associated with the drug. The FDA also requested Pfizer change the information provided to physicians to reflect the recommendations FDA made encouraging physicians to consider alternative therapies as they evaluate their individual patient needs. Pfizer agreed to suspend its Celebrex promotion and to craft appropriate detailing to physicians that reflects the uncertainty of scientific data currently available.

Common Side Effects of Celebrex

In addition to the serious side effects listed below, some common, but less serious side effects associated with Celebrex include:

Headache
Indigestion
Upper respiratory tract infection (a "cold")
Diarrhea
Sinus inflammation
Stomach pain
Nausea

Who Should Not Take Celebrex

According to Pfizer, patients should not take Celebrex if they have aspirin-sensitive asthma, or allergic reactions to aspirin or other arthritis medicines or certain sulfa drugs called sulfonamides, or if they are in their third trimester of pregnancy.

Special Warnings with Celebrex

Celebrex and other NSAID medicines can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Celebrex and with higher doses of Celebrex. Stomach bleeding can also happen suddenly while you take Celebrex. Stop taking Celebrex and call your healthcare provider right away if you get:

A burning stomach pain;
Black bowel movements that look like tar;
Vomit that looks like blood or coffee grounds.

Celebrex and other NSAID medicines can cause serious allergic reactions that include swelling of the face, lips, tongue or throat. These allergic reactions may cause problems with breathing, swallowing, and wheezing. Serious allergic skin reactions have also been reported with the use of NSAIDs. If you experience any of these symptoms, contact a physician immediately.

$89 Million Proposed Class Action Settlement Provides Consumers and Insurers With Money Back for Celebrex and Bextra Purchases and Reimbursements

A federal court in San Francisco has granted preliminary approval to a proposed settlement with Pfizer Inc. ("Pfizer") about the marketing of the prescription drugs Bextra and Celebrex. The settlement in the case called In re Bextra and Celebrex Marketing, Sales Practices, and Product Liability Litigation, No. 05-CV-01669, MDL No. 1699, pending in the United States District Court for the Northern District of California, will provide a Settlement Fund of $89 million to benefit a class of consumers and insurance companies or other entities (also called Third-Party Payors) that paid for either medicine before July 29, 2005.

The lawsuit, which does not concern safety risk of either drug, claims that Pfizer falsely advertised Bextra and Celebrex as having greater benefits than less expensive pain medications, causing consumers and other entities to pay a greater price for Bextra and Celebrex than they would otherwise have paid for less expensive alternatives or no medications at all. The lawsuit also claims that the advertising was not consistent with the drugs' Food and Drug Administration approved labeling. Pfizer denies any wrongdoing and denies all of the claims in the lawsuit but is settling this lawsuit to avoid the cost and expense of further litigation.

Consumers who paid for Bextra and/or Celebrex on or before July 29, 2005 are included in the Proposed Settlement. Third-Party Payors that paid or reimbursed for all or a percentage of the cost of Bextra and/or Celebrex on or before July 29, 2005 can also make a recovery under the Proposed Settlement. Third-Party Payors include insurance companies, union health and welfare plans, and self-insured employers.

Consumers and Third-Party Payors that wish to remain in the Settlement and file a claim will be bound by the Court's orders and will give up the right to sue the defendants on their own. Claim forms must be postmarked by October 23, 2009.

The Court will hold a Final Approval Hearing on September 25, 2009 at 10 a.m. to consider whether the Proposed Settlement is fair, reasonable, and adequate and the motion for attorneys' fees and expenses.

Celebrex - Pain Pills in Heart Failure Patients May Be Risky

Tuesday, February 3, 2009

NEW YORK (Reuters Health) - Use of a class of painkillers known as nonsteroidal anti-inflammatory drugs (NSAIDs) by patients with chronic heart failure is associated with increased risk of death and cardiovascular illness, new research suggests.

"Accumulating evidence" points to increased cardiovascular risk associated with NSAID use, in particular in patients with established cardiovascular disease, Dr. Gunnar H. Gislason, of Gentofte University Hospital, Hellerup, Denmark, and colleagues note in the Archives of Internal Medicine.

In the current study, they assessed the risk of death and hospital admission for heart attack or heart failure associated with the use of NSAIDs in 107,092 patients who survived a first hospitalization for heart failure. Heart failure is a chronic disease in which the heart gradually loses its ability to pump blood efficiently, leaving organs starved for oxygen.

Quick Facts

Manufacturer
Pfizer
Status
On the market
Intended Uses
Rheumatoid Arthritis and Osteoarthritis treatment
Complications
Serious risk of heart attack and stroke, bleeding stomach ulcers, liver damage, kidney problems

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