Pain Drug Caution for Heart Patients

People with heart risks should take the pain drug Celebrex
as a last resort and for the shortest possible time because of heart attack and
stroke risk, says the American Heart Association (AHA).

For those patients, caution may also be warranted for the long-term use of
other nonsteroidal anti-inflammatory drugs (NSAIDs), notes the AHA.

The AHA's advice: If you've got heart disease, a history of heart problems,
or are at high risk for heart disease, try physical therapy, weight loss (if
necessary), and other pain medications before NSAIDs, and consult your doctor
before taking any NSAID for a long period of time.

That advice applies to prescription NSAIDs and the over-the-counter NSAIDs
ibuprofen and naproxen, but not to aspirin.

However, the drug company that makes Celebrex says the AHA's advisory
provides "oversimplified treatment recommendations, which are not based on
robust clinical data."

The AHA's recommendations appear online in Circulation.

About NSAIDs

The AHA's advisory isn't based on new studies. Instead, it sums up current
NSAID research.

NSAIDs (except for aspirin) have been linked to increased risk of heart
attack and stroke, especially in patients with a history of heart disease or
those who are at high risk for heart problems, notes the AHA.

Those risks prompted two prescription NSAIDs -- Vioxx and Bextra -- to be
withdrawn from the market in 2004 and 2005, respectively.

In April 2005, the FDA ordered new label warnings for all NSAIDs except
aspirin. Those labels include a "black box" warning for NSAIDs.

Last Resort

Cox-2 inhibitors, a type of NSAID, may be particularly risky for heart
patients, note Elliott Antman, MD, and colleagues, who wrote the AHA
advisory.

Celebrex, the only Cox-2 inhibitor on the market, already carries a
"black box" warning that notes heart attack and stroke risk.

"For chronic pain in patients with known heart disease or who are at
risk for heart disease, these drugs (Cox-2 inhibitors) should be the last line
of treatment," Antman says in an AHA news release.

Antman is a professor of medicine at Harvard Medical School and also works
at Boston's Brigham and Women's Hospital.

The risk of heart attack, stroke, heart failure, and high blood pressure is
"likely greatest in patients with a prior history of or at high risk for
cardiovascular disease," write Antman and colleagues.

"In these patients, use of Cox-2 inhibitors for pain relief should be
limited to patients for whom there are no appropriate alternatives, and then,
only in the lowest dose and for the shortest duration necessary," they
write.

Though the guidelines support the use of other pain relievers (including
narcotics) before trying NSAIDs, Antman's team doesn't totally dismiss NSAIDs
for patients with heart risks.

"From both the patient's and the physician's perspectives, the problem
lies in balancing the risks and benefits of medications for pain relief,"
write Antman and colleagues.

Further studies are needed, but until more data become available, long-term
use of NSAIDs other than aspirin "should only be considered in consultation
with a physician," write Antman and colleagues.

Drug Company Responds

WebMD contacted Pfizer, the drug company that makes Celebrex.

A Pfizer spokeswoman emailed a news release responding to the AHA
advisory.

"It is important to remember that all NSAIDs, except for aspirin, carry
the same cardiovascular warning, which is based on the similar potential for
affecting heart health. In fact, the U.S. Food and Drug Administration has
concluded that the available data does not support ranking these medications
with regard to heart risk," states Pfizer.

Pfizer calls Celebrex "an important treatment option" for millions
of arthritis patients and says patients should consult ther doctor to weigh
their risk-benefit profile for NSAID treatment.

"Respectfully, we believe the AHA's new guidance provides oversimplified
treatment recommendations which are not based on robust clinical data,"
states Pfizer.

Pfizer voices "particular concern" about the AHA's suggestion to try
narcotic pain relievers before trying NSAIDs. "These recommendations may
further confuse arthritis patients and their doctors," states Pfizer.

Pfizer says it is supporting an ongoing study to assess the relative safety
of prescription-strength ibuprofen, naproxen, and Celebrex at doses commonly
used to treat arthritis.

Pfizer is a WebMD sponsor.

By Miranda Hitti
Reviewed by Louise Chang
B)2005-2006 WebMD, Inc. All rights reserved