Vioxx Ban Tied to Rise in Serious GI Trouble

By E.J. Mundell
HealthDay Reporter
Friday, November 9, 2007; 12:00 AM

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THURSDAY, Nov. 8 (HealthDay News) -- Pulling the painkillers Vioxx and Bextra off the market to spare patients' hearts may have ended up harming their stomachs, a new study suggests.

Rates of gastrointestinal events serious enough to require hospitalization have risen significantly since the cox-2 inhibitor medications were ordered off the market in 2004-2005, researchers say.

"It's like our focus shifted from the reason that we were using these drugs -- against GI bleeds -- and onto something else. We left our eye off the ball, and this is what has happened," said study author Dr. Gurkipal Singh, a rheumatologist and a clinical professor of medicine at Stanford University School of Medicine.

His team presented its findings Thursday at the American College of Rheumatology annual meeting, in Boston.

Cox-2 inhibitors such as Vioxx, Bextra and Celebrex are a subset of a larger group of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs such as aspirin, ibuprofen (Advil, Motrin) and naproxen (Aleve) relieve pain, but they also raise risks for GI tract complications, including bleeding.

Cox-2 inhibitors were heralded as a safer alternative to other NSAIDs precisely because they offered users a much lower risk of these side effects.

In their heyday, millions of Americans took the drugs. However, beginning in late 2004, the U.S. Food and Drug Administration called for the withdrawal of Vioxx and then Bextra, after studies suggested higher rates of serious cardiac events in long-time users. Only Celebrex remains on the market.

The Vioxx and Bextra withdrawals may have come at a cost, however, as Americans battling pain reached again for NSAIDs.

In their study, Singh's team tracked the use of cox-2 inhibitors from their introduction in 1999 until the end of 2005. In total, they looked at almost 4.5 million prescriptions for NSAIDs written for American arthritis patients over 65.

The Stanford team found that the rate of serious gastrointestinal events -- bleeding ulcers leading to hospitalization or death -- declined steadily from 1999 to 2003 as sales of cox-2 painkillers surged.