Q: What is Celebrex?
A: Celebrex or celecoxib was given approval by the US Food and Drug Administration on December 31, 1998 to treat rheumatoid arthritis and osteo-arthritis. And on December 23, 1999, the FDA also granted approval Celebrex as medication to reduce some intestinal polyps in patients with an uncommon genetic disorder which is called as familial adenomatous polypsis or FAP. Celebrex is a non-steroidal anti-inflammatory drug or NSAID and belongs to drug category called “Cox-2 inhibitor.”
Q: What is the latest news regarding Celebrex?
A: The National Institute of Health or NIH declared on December 17, 2004, that it had stopped the use of COX-2 inhibitor celecoxib with brand name Celebrex for all the participants in a huge colorectal cancer prevention clinical trial; done by the National Cancer Institute or NCI. The study was called Adenoma Prevention with Celecoxib (SPC) trial, was halted because the analysis done by the Data Safety and Monitoring Board or DSMB revealed that there were 2.5 more increased risks of fatal and non-fatal cardiovascular activities for the participants using the drug as compared to those on placebo.
In the APC clinical trial, the patients who are using the 400 mg of Celebrex two times every day had 3.4 times more risks of cardiovascular activities compared to those who are using a placebo. With patients in the trial taking the 200 mg of Celebrex mg two times every day, the risk was 2.5 times more. The average duration of the treatment in the trial was about 33 months. However, it was found out that another similar study was ongoing comparing the Celebrex 400 mg once every day against placebo in patients with the same duration of time, has not shown any increased risk.
Pfizer and the FDA are presently assessing the data from these two studies.
On the same date of December 17, FDA asked Pfizer to voluntarily stop their direct-to-consumer promotion on Celebrex during the period FDA is getting and evaluating the new and contrasting scientific data on adverse events related to the drug. FDA also recommended that Pfizer change its information given to doctors to mirror the suggestions of FDA to encourage doctors to consider other alternative remedies as they evaluate their patient’s needs. Pfizer consented to halt the advertising of Celebrex and to design appropriate detailing to doctors that show the uncertainty of scientific data presently available.
Q: Can a pharmacist continue to fill my prescription for Celebrex?
A: The answer is yes. Celebrex has not been removed in the USA and continues to be available by prescription.
Q: What should I tell the doctor before he/she prescribes me with Celebrex?
A: You must inform your doctor if you:
- Drink alcohol;
- Have congestive heart failure;
- Have heart problems;
- Have hypertension;
- Have an ulcer or some bleeding in the stomach;
- Have fluid retention;
- Have a coagulation or bleeding disorder or if you are using an anti-coagulant, commonly known as blood thinner;
- Have a liver or kidney illness, asthma;
- Pregnant or breastfeeding;
- Experience on allergic reactions after using aspirin or any other NSAID;
- Taking steroid treatment like Prednisone; and/or
- Had an allergic reaction to sulfa-based procedure.
Q: What should I tell the doctor if I suspect I have arthritis?
A: Inform your doctor about the following:
- Where you have pain or stiffness;
- What the pain feels like ( sharp or stabbing, dull or aching);
- How long the pain lasts;
- How long you have had the pain;
- What are the tasks you have difficulty in doing presently;
- Had any injury in your joints or overused them in a job or hobby;
- If your family has the same sufferings; and
- If you are exercising, what kind of workout do you have and how often you do it.
Q: What should I ask the doctor about the treatment of arthritis before leaving the doctor’s clinic?
A: You can ask the following questions:
- What can I do to help relieve my pain and live more comfortably?
- What are the pros and cons of the different treatments?
- When shall I expect to feel better after I start my treatment?
- What can I expect over the coming years or months?
- What circumstances should I call your clinic?
Q: What must I do if I think I have been injured as a result of using Celebrex?
A: If you experience unusual side effects after using Celebrex. Consult your doctor immediately. Then, you can find a reliable lawyer who is experienced in product liability litigation to discuss some potential legal claims you can recover for injuries caused by Celebrex.
Q: How can I succeed in suing the producer of a drug like Celebrex?
A: Since all drugs or treatments have particular side effects, a drug producer has the obligation to make its pharmaceutical products safe for human consumption and inform the medical community and the general public of known health risks related with the drugs or treatments. If a producer fails to do this, then they are liable to patients who are injured as a result of insufficient or lack of warnings or the unreasonable hazards of the drug under a legal theory called “product liability.”