New Pain Pills: Not Easier to Stomach?
Stomach-Protecting Pills May Be Best Way to Avoid Painkillers' Side Effect
WebMD News Archive
Dec. 1, 2005 - The new generation of pain drugs is supposed to be easier on
the stomach. But new data suggest that older pain drugs plus stomach-protecting
drugs work better.
Newer pain drugs are called Cox-2 inhibitors. The family includes Vioxx,
Bextra, and Celebrex. The drugs became widely popular because they were
supposed to be safer than older pain drugs -- traditional non-steroidal
anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. Ironically,
Vioxx and Bextra were pulled from the market due to rare but potentially deadly
heart side effects.
Yet clinical trials have shown that the Cox-2 inhibitors caused less stomach
bleeding than the traditional NSAIDs. Now a new study -- which focused mainly
on Vioxx -- shows that patients taking Cox-2 inhibitors had no fewer stomach
bleeds or ulcers than those taking traditional NSAIDs.
The study appears in the Dec. 3 issue of BMJ.
The news isn't all bad, however. The researchers found that patients taking
any kind of NSAID were able to avoid stomach bleeding and ulcers simply by
combining them with stomach-protecting drugs.
Julia Hippisley-Cox, MD, and colleagues gathered information on 9,407 U.K.
patients who suffered stomach bleeding or ulcers. They matched these patients
to nearly 89,000 patients who didn't have stomach problems.
Patients were about one-and-a-half to two times more likely to have stomach
problems if they were taking naproxen, aspirin, Vioxx, or ibuprofen. They did
not find any stomach problems with Celebrex. But the study researchers downplay
this finding because so few of the patients -- all treated between July 2000
and August 2004 -- took Celebrex.
Role of Cox-2 Drugs
But Cox-2 expert A. Mark Fendrick, MD, suggests that the patients who were
given Cox-2 drugs had a higher risk of stomach problems to start with. Fendrick
is professor of internal medicine and of health management and policy at the
University of Michigan.
Patients with previous stomach problems are often given Cox-2 inhibitors
instead of traditional NSAIDs. This could have skewed the findings, says
Fendrick. "You could argue that the Cox-2 drugs were slightly better,"
he tells WebMD.
And a recent study found that doctors tend to prescribe Cox-2 drugs to
patients who have a higher risk of stomach bleeds, says Harvard rheumatologist
Lee Stuart Simon, MD. Simon recently finished a four-year stint as director of
the branch of the FDA that monitors both the Cox-2 drugs and traditional
"The question is, if a patient has pain and has a gastrointestinal risk
-- beginning with age over 60, and then past history of ulcer, other drugs that
cause bleeding risk, or being very frail and sick -- taking an NSAID adds up to
a significant risk," Simon tells WebMD. "So if I saw a patient like
that I would choose a [Cox-2 inhibitor] over a traditional NSAID."