British Study Finds Increased Risk Of GI Problems For COX-2 Inhibitors And NSAIDs

Vioxx, Bextra, and Celebrex, those "new" painkillers called COX-2 inhibitors, were suppose to be safer for your stomach than many traditional anti-inflammatory medications, such as aspirin or other treatments called non-steroidal anti-inflammatory drugs (NSAIDs).  A study published in the December 3, 2005 issue of the British Medical Journal (BMJ), however, says that there is no evidence in support of this gastrointestinal (GI) safety claim by makers of the COX-2 drugs.

The study published in the December 3 issue of BMJ was led by Julia Hippisley-Cox, of the University of Nottingham, in England.  In this study, British researchers looked at 9,407 patients who had been diagnosed with a stomach ulcer or GI bleeding.  According to the BMJ report of this British study, 45 percent had received a conventional non-steroidal anti-inflammatory drug (NSAID), and 10 percent had been given a COX-2 inhibitor, the newer generation of anti-inflammatory drugs.

In the final analysis, these researchers found an increased risk of ulcers and stomach associated with both the COX-2 inhibitors — such as Vioxx, Bextra, and Celebrex — as well as other NSAIDs — such as naproxen and diclofenac. The study did point out that the risk was slightly reduced for Celebrex (celecoxib), made by Pfizer. As most interested persons know by now, Celebrex is the only COX-2 inhibitor that remains on the U.S. market after Vioxx and Bextra were removed from the market in September 2004 and April 2005, respectively, because of concerns over cardiovascular side effects.  For Bextra, there was the added component of serious skin reactions, including Stevens-Johnson syndrome (SJS).

The results of this British study are especially remarkable because the COX-2 drugs were specifically designed to provide pain relief without the serious gastrointestinal side effects historically associated with the traditional NSAIDs.  Dr. Hippisley-Cox and her team of researchers reported in the December BMJ article that, "we found no consistent evidence of enhanced safety against gastrointestinal events with any of the new cyclo-oxygenase-2 inhibitors [COX-2 inhibitors], compared with non-selective, nonsteroidal, anti-inflammatory drugs [NSAIDs]".

Given its findings, this study indicates that there are increased gastrointestinal (GI) risks, including ulcers and stomach bleeding, associated with using any of these painkillers.  The real import of this study, however, is that the increased GI risk apparently includes the COX-2 drugs — despite what we heard from Merck and Pfizer in their promotional materials in recent years.

(Posted by: Tom Lamb)