Safety of Entire Family of Painkillers Questioned

Wed Nov 24, 2004

5:03 PM ET   Health - HealthDay

By Amanda Gardner
HealthDay Reporter

WEDNESDAY, Nov. 24 (HealthDayNews) -- The withdrawal of Vioxx from
the market in September and more recent concerns about its cousin
Bextra have raised safety questions about this entire class of
painkillers: Are there one or two bad apples, or is the bunch

Consumers, physicians, and now regulatory agencies as well have been
brought into the argument. Two key advisory committees of the U.S.
Food and Drug Administration (news - web sites) will be looking into
the safety of this class, called cox-2 inhibitors or coxibs, in mid-

Merck & Co., Inc., pulled Vioxx off the market when a trial showed
that its users had nearly twice the risk of heart attack and stroke.
Preliminary information shows that Bextra may have similar problems
among patients with heart disease. Pfizer, Inc., which makes Bextra,
disputed the information, but has said it will add a black box
warning about a potentially fatal skin reaction.

Despite the controversy, not everyone is agreed on the future of
drugs that were once hailed as a breakthrough for being able to
relieve pain without the traditional gastrointestinal (GI)
complications of nonsteroidal anti-inflammatory drugs (NSAIDs).

"We don't know that any of the cox-2 inhibitors are perfectly safe,"
said Dr. Eric Topol, chairman of cardiovascular medicine and chief
academic officer of the Cleveland Clinic, who was one of the first to
speak out about possible problems. "Two out of three are already
signed on as being problematic. One has been withdrawn [Vioxx], one
is probably getting a black box [Bextra], and Celebrex may be a small
hazard, but we just don't know."

Physicians who are in the business of treating arthritis sufferers,
however, believe there may still be a place for these drugs.

"If patients are at a higher risk than normal for ulcers, this is a
great choice," said Dr. Todd Schlifstein, assistant professor of
rehabilitation medicine at New York University School of Medicine. "I
feel comfortable prescribing those two [Celebrex and Bextra]. I have
no hesitation. Obviously, if they have a history of cardiovascular
disease, heart attacks, stroke or high blood pressure, I would use
them cautiously."

"I think they have a place. They certainly work in a lot of people,"
said Dr. Stephen Lindsey, section head of rheumatology at the Ochsner
Clinic Foundation in Baton Rouge, La. "A lot of people didn't respond
to other drugs."

The main concern among these doctors was the high proportion of
complications experienced by people on traditional NSAIDs.

According to Schlifstein, 16,500 people die every year from NSAID-
related GI complications, and another 131,000 go to the emergency
room. "We're talking billions of dollars and thousands of lives that
these things save," he said. "That's the reason we put people on
these things. If we put everyone back on ibuprofen, clear out the
emergency room and get ready for the bleeds."

"Most people who were on Vioxx were on it for a reason. It has less
GI toxicity. It decreased ulcer complications and death from ulcer
disease," Lindsey added. "You should never use the normal
nonsteroidals on elderly people who have a lot of co-morbidity."

By the same token, people with any kind of heart disease or risk
factors for heart disease, such as high blood pressure, should
probably never have been on Vioxx in the first place. Those
complications had already been noted.

"I think if we just avoided people with severe heart disease, that
would probably take care of most of the problems with Vioxx," Lindsey
said. "The problems were with higher doses and people with heart

When Vioxx was first pulled, Lindsey switched many of his patients to
Celebrex, which "appears to have the best data and the least risk,"
he said. Most people taking these drugs for pain never approach the
high doses used in the clinical trials, he pointed out.

This group of drugs may be particularly well suited for acute pain,
which does not require long-term therapy, Lindsey added. "For five to
10 days, it's probably very safe," he said.

Topol, however, recommended that people with arthritis and health
problems should take naproxen (Naprosyn, Aleve).

More information

For more on arthritis drugs, visit the Arthritis Foundation.