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Vioxx Ban Tied to Rise in Serious GI Trouble
Date:11/8/2007

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"We got into this mess in the first place, because we had known for a long time that non-steroidals of all types have a well-documented increase in GI adverse events," he said. "So, we created two strategies to prevent them."

One strategy was to use a cox-2 inhibitor to help relieve pain. The other was to "buffer" an NSAIDs effect on the GI tract by giving patients medications such as proton pump inhibitors (PPIs), which protect against bleeding. PPIs include drugs such as Nexium and Prilosec.

The second strategy remains useful, he noted. "In patients who have known GI risk factors and are taking aspirin, most experts now suggest that you have to have additional gastroprotective therapy [such as a PPI] whether you are on a cox-2 inhibitor or not," Fendrick said.

Another expert agreed, but said doctors are often in a bind when a patient taking an NSAID comes to them with gastrointestinal problems.

Switching to the remaining cox-2, Celebrex, is an option, but many drug plans won't pay for it, said Joe Biskupiak, a research associate professor of pharmacology at the University of Utah in Salt Lake City.

"The easier solution is clearly taking a gastroprotective agent," he said.

Unfortunately, the blockbuster drug Prilosec has been sold over-the-counter since 2003, meaning that most drug plans won't pay for it, either.

"This creates a problem for physicians. They know what the right thing is to do -- just tell the patient to go to the store and buy [Prilosec]," Biskupiak said. "But many patients aren't going to do that."

The result is patients wind up with little protection against gastrointestinal troubles, he said.

So, was the FDA's decision to withdraw Vioxx and Bextra wrong?

"I don't have an answer to that," Singh said. "To my own mind, the whole noise around this issue has just led to a dramatic decrease in cox-2 inhibitor use but not a concomitan
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