THE VIRGINIAN-PILOT 
              Copyright (c) 1995, Landmark Communications, Inc.

DATE: Thursday, October 12, 1995             TAG: 9510120336
SECTION: FRONT                    PAGE: A8   EDITION: FINAL 
SOURCE: ASSOCIATED PRESS 
DATELINE: GAITHERSBURG, MD.                  LENGTH: Medium:   53 lines

FDA PANEL DECIDES NOT TO BAN POPULAR ARTHRITIS MEDICINE RATHER THAN SINGLE OUT ONE, THEY'LL LOOK AT THE WHOLE CLASS.

The popular arthritis drug Feldene, attacked for causing serious and sometimes fatal stomach problems, is not dangerous enough to ban, scientists told the government Wednesday.

But the Food and Drug Administration advisers expressed concern over growing signs that several members of this entire family of medicines, called nonsteroidal anti-inflammatory drugs or NSAIDs, may be riskier than patients and their doctors think.

NSAIDs are among the most popular pain and inflammation relievers on the market. They range from the relatively benign ibuprofen, sold under the brand names Motrin, Advil and others, to the stronger piroxicam, sold under the brand name Feldene by Pfizer Inc. and generically.

In high doses, all NSAIDs are linked with an increased risk of such gastrointestinal problems as ulcers and internal bleeding. NSAIDs are blamed for 41,000 hospitalizations and 3,300 deaths from gastrointestinal problems every year.

The consumer advocacy group Public Citizen filed a petition urging the FDA to ban piroxicam, arguing that it causes more of these problems than other NSAIDs.

FDA figures show that 299 Americans taking piroxicam have died since 1982, including 144 whose deaths were linked to ulcers, perforations or bleeding of the stomach and intestines, said Public Citizen's Dr. Sidney Wolfe.

Of particular concern are elderly patients, who do not metabolize drugs as easily as younger people, he argued. It can take between 30 and 86 hours for the body to eliminate half a dose of piroxicam, compared with less than three hours to clear the same dose of ibuprofen - and some elderly Feldene patients take over 100 hours, he said.

Doctors prescribed piroxicam almost 4 million times last year to treat arthritis. It is the only NSAID that can be taken just once a day.

It takes 3,200 milligrams of ibuprofen to cause the same risk as the standard daily dose of 20 milligrams of piroxicam, said FDA panelist Dr. Lee Simon of Harvard.

But Pfizer officials presented studies showing piroxicam is no more dangerous than at least three other NSAIDs on the market, and ultimately the FDA panel unanimously agreed that it would be unfair to single out that drug.

The question now is whether all potentially dangerous NSAIDs deserve more warnings to doctors and patients, something the FDA panel will decide today.

KEYWORDS: FELDENE FDA ARTHRITIS by CNB