The American Heart Association issued new guidelines for Pfizer's Celebrex, advising doctors the painkiller should only be used as a last resort on patients who have heart disease or a risk of developing it, CNBC's Mike Huckman reported.
Celebrex is a COX-2 inhibitor and it's the only drug in that class still on the market in the U.S. after Merck pulled Vioxx and Pfizer pulled Bextra off pharmacy shelves.
In a prepared statement, Pfizer told Huckman the AHA's recommendations are "oversimplified" and "not based on robust clinical data … and may further confuse patients."
But the American Heart Association says a recent analysis show that COX-2 drugs increase the risk of having a heart attack by 86%. The drug already has a so-called black box warning label, the FDA's toughest warning of heart risk since 2005.
Dr. Elliott Antman, lead author of the AHA's scientific statement and a professor at Harvard Medical School, makes no bones about Pfizer's Celebrex.
"It is not a safe drug," says Antman. "It is not a drug we should turn to as a first line treatment for management of pain in a patient with heart disease. We're actually recommending that it be the last line of treatment."
Antman said heart disease patients should be instructed to diet and exercise and failing that, to try aspirin first, then Tylenol or Aleve.
The most infamous of the COX-2 class is Vioxx, which was pulled from the market by Merck in 2004 after it was discovered that the drug raised the risk of heart attacks and strokes.
After Vioxx fears eventually subsided, sales of Celebrex rebounded last year with 2006 sales of $2 billion. Pfizer has said it expects the rebound to continue for the franchise again this year.