Celebrex - FAQs

Q: What is Celebrex?

A: Celebrex (Celecoxib) is a drug prescribed for treating rheumatoid arthritis, osteo-arthritis, and familial adenomatous polyposis. The U.S. Food and Drug Administration (FDA) approved Celebrex for consumer use on December 31, 1998. Celebrex is a non-steroidal anti-inflammatory drug (NSAID), and is in a class of drugs commonly referred to as a "Cox-2 inhibitor."

Q: What is the recent news regarding Celebrex?

A: On December 17th, 2004 the National Institutes of Health (NIH) announced that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major cardiovascular events for participants taking the drug compared to those on a placebo.

In the APC clinical trial, patients taking 400 mg. of Celebrex twice daily had a 3.4 times greater risk of cardiovascular events compared to placebo. For patients in the trial taking 200 mg. of Celebrex twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months. However, a similar ongoing study comparing Celebrex 400 mg. once a day versus placebo, in patients followed for a similar period of time, has not shown increased risk.

Also on December 17, 2004, the FDA asked Pfizer, Inc. 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 events associated with the drug. 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.

Q: Can a pharmacist continue to fill my prescription for Celebrex?

A: Yes, Celebrex has not been withdrawn in the United States and continues to be available by prescription.

Q: What should I tell the doctor before he/she prescribes me Celebrex?

A:  Before taking Celebrex, you should tell the doctor if you:

• Drink alcohol;

• Have an ulcer or bleeding in the stomach;

• Have liver or kidney disease; have asthma;

• Have congestive heart failure;

• Have fluid retention;

• Have heart disease;

• Have high blood pressure;

• Are pregnant or breastfeeding;

• Have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner);

• Are taking a steroid medicine such as Prednisone;

• Have had an allergic reaction to sulfa-based medications; or

• Have experienced an allergic reaction after taking aspirin or any other NSAID.

Q: What should I tell the doctor if I suspect I have arthritis?

A:  There are a number of signs and symptoms associated with arthritis. The following include some of the things you should tell your doctor: where you have pain or stiffness; when you have pain or stiffness; what the pain feels like (sharp/stabbing, dull/aching); how long the pain lasts; how long you have had the pain; what tasks you find difficult to do now; if you ever injured your joints or overused them in a job or a hobby; if anyone in your family had problems similar to yours; if you exercise, what kind of exercise you do and how often you do it.

Q: What questions should I ask before leaving the doctor's office for treatment of arthritis?

A:  What can I do to help relieve my pain and live more comfortably?  What are the advantages and disadvantages of my various treatment options?  When might I expect to start feeling better?  What can I expect over the coming months/years?  Under what circumstances should I call your office?

Q: What should I do if I think I have been injured as a result of taking Celebrex?

A:  If you have experienced unusual side effects after taking Celebrex, you should consult your physician immediately. Thereafter, you might want to contact a product liability attorney to discuss potential legal claims you might have to recover for injuries Celebrex caused you.

Q: How could I succeed in suing the manufacturer of a drug like Celebrex?

A:  While all medications have certain, anticipated side effects, a drug manufacturer has a duty to make its pharmaceutical products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called product liability.