04/14/2008- On March 31, 2008, a study funded by the National Cancer Institute, was published in the medical journal Circulation and analyzed data from six separate studies involving nearly 8,000 patients concerning the safety of the drug Celebrex.  Data showed that patients who took two 400 mg doses of Celebrex daily had a three times (or 300%) higher risk of suffering heart attacks, strokes, heart failure, blood clots, and cardiovascular death.  An interesting finding was that patients who took 200 mg doses of Celebrex had a higher risk of nearly 200% of suffering cardiovascular injuries than patients who ingested the same 400 mg daily but in a single dose, which may be attributable to a relatively small number of patients who ingested Celebrex pills only once a day.   The risks were more significant in patients who had other cardiovascular risk factors, such as diabetes and heart disease.   There was no data analyzed regarding the risks that might be associated with use of Celebrex at 200 mg per day, the most common dose used by patients in light of all of the recent information regarding the significant cardiovascular risks of all of the Cox-2 inhibitors (Vioxx, Bextra, Celebrex, and Arcoxia). 

Celebrex is a Cox-2 inhibitor that already carries a "black box" warning regarding heart attack and stroke risk, which, along with the demise of Vioxx, led to a 50% decrease in the sales ofthe popular arthritis drug.  The American Heart Association guidelines indicate that people should take Celebrex as a "last resort" and for the shortest time possible because of the risks of heart attack and strokes. 

A Pfizer spokeswoman commented on the study in a Bloomberg.com report and tried to distance Celebrex from Vioxx (despite consistent reports of similar cardiovascular risks) and instead attempted to reassure patients that the risks reported in this study are "consistent with Celebrex's current prescribing information."  The Bloomberg.com report also notes that Pfizer is having difficulty recruiting patients for ongoing studies to determine whether Celebrex is safe for use at the lowest doses that are currently recommended due to "negative publicity surrounding the category of drugs."  Additional studies are anticipated in 2010 or 2011 that would perhaps provide further answers regarding the safety of Celebrex at the most commonly prescribed doses as compared to ibuprofen and naproxen.  

This new study and Pfizer's response lead to a number of questions:

     1.    Are prospective study participants receiving better information than patients about the risks of Celebrex since extensive informed consent is required prior to entry into a study?  Pfizer focued on the "publicity", but it is hard scientific data - not editorials - that are pointing to serious safety issues with respect to Celebrex.  Thankfully, the "publicity" has reached at least half of patients who chose to dump Celebrex because the risks of the drugs outweighed any benefit.  One can only wonder whether the other 50% of patients who remained on Celebrex and purchased $2.3 billion of the drug in 2007 made rational personal choices to remain on the drug or just did not have access to adequate information of their medications.  Is it sufficient for this type of risk information to be buried in a label that most patients never see? 

    2.    Why don't we know more about the risks of Celebrex by now? The arthritis drug was approved for sale in this country in 1999, and was the first Cox 2 inhibitor introduced in the United States.  The latest reports indicate that the studies that might provide some answers on whether the drug is safe at the most commonly-used doses won't be available until more than a decade after its approval by the FDA.  Is it acceptable to permit patients to serve as guinea pigs for the 10-year or more run on a new drug?  Finally, will we ever see the much-anticipated safety studies on Celebrex, or will the drug fade away just prior to expiration of the patent and prior to completion of critical safety studies? 

I guess we will just have to wait until 2011 to see.