December 15, 2006: FDA Approves New Use for Celebrex

The US Food and Drug Administration or US FDA has granted approval to Celebrex for the relief of symptoms that are related to Juvenile Rheumatoid Arthritis or JRA on patients two years old and above. JRA is a severe condition referred to as autoimmune illness that affects more than 30,000 children in USA.  Symptoms of JRA are as follows: joint swelling and pain, limited movements to permanent disability in severe and uncontrolled cases. Press here to read the FDA press release.

It was on December 17, 2004, when the National Institute of Health or NIH declared that it suspended the use COX-2 inhibitor celecoxib or Celebrex for all participants in a huge colorectal cancer prevention clinical trial done by the National Cancer Institute or NCI. The study was called as the Adenoma Prevention with Celecoxib or APC trial but it was stopped due to the result of the analysis made by the Data Safety and Monitoring Board or DSMB which revealed 2.5-more increased risks of major fatal and non-fatal heart activities for the study participants who took the drug as compared to placebo.

In the APC clinical trial, the patients who took 400 mg of Celebrex two times a day had 3.4 times greater risks of heart activities as compared to placebo. The patients who took 200 mg of Celebrex had a risk of 2.5 times more. The average time of treatment in the trial was 33 months.  It was learned that aside from this study, there was a similar study comparing Celebrex 400 mg once every day against placebo, to patients following the same duration, and results showed that it has not showed increased risk.

The producers of Celebrex which is Pfizer and FDA are presently assessing the data from the studies.

On the same day, December 17, FDA asked Pfizer Inc. to voluntarily stop the direct-to-customer advertising on Celebrex during the period FDA is getting and evaluating the new and the conflicting scientific data on adverse events related with the drug. FDA also asked Pfizer to change the information given to the doctors to consider the recommendations made by the FDA asking the doctors alternative remedies during their evaluation of their patient’s needs. Pfizer consented to stop advertising Celebrex and to design more appropriate detailing to doctors that mirror the ambiguity of scientific data presently available.

Read more about the news at:

• NIH Halts Use of COX-2 Inhibitor in Large Cancer Prevention Trial (NIH)
• FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex (FDA)
• Pfizer Statement on New Information Regarding Cardiovascular Safety of Celebrex (Pfizer, Inc.)