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CNN's Rhonda Rowland reports on the drug Celebrex
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April 21, 1999
Web posted at: 6:27 p.m. EDT (2227 GMT)

In this story: 'Super aspirin' label inaccurate FDA: Too early to draw conclusions about Celebrex safety RELATED STORIES, SITES

WASHINGTON (CNN) -- An advisory panel has recommended to the U. S. Food and Drug Administration (FDA) approval of Vioxx, a second drug in a new class of painkillers. Tuesday's move follows a report suggesting links between the first of these new painkillers, Celebrex, and certain complications including possible death.

After three months on the market and 2.5 million prescriptions filled, there are reports linking Celebrex to 10 deaths and 11 cases of gastrointestinal hemorrhages, according to the FDA.

Vioxx made my Merck, the second Cox-2 Inhibitor to come before the FDA, was recommended Tuesday for use only in treating arthritis. Celebrex was approved in December also for the exclusive treatment of arthritis. Rheumatoid arthritis affects more than three-million Americans, and osteo-arthritis affects about 16-million Americans. Both conditions cause pain and joint deterioration.

When Celebrex was approved, it was hailed as a breakthrough painkiller. It was touted as a safe alternative to other "NSAIDs," or non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen. Each year some 16,000 people in the U.S. die from gastrointestinal complications caused by NSAID use.

NSAIDs work by blocking enzymes known and Cox-1 and Cox-2. But Celebrex blocks only Cox-2, providing pain relief without stomach trouble. Therefore, it was hoped that Celebrex will be safer than other NSAIDs for longterm use.

Some have called Celebrex and other drugs with the drug classification Cox-2 Inhibitor "super aspirin." But medical researchers say this label is not really accurate since these drugs are not stronger than aspirin, but have been generally considered safer.

The chairman of the FDA panel says studies indicate both Vioxx and Celebrex are safer than other NSAIDs, but how much safer is unclear.

The panel has asked for studies to answer the question, but until research provides a more definitive understanding of the matter, patients will continue to be warned that while stomach ulcers are rare, they are a possible side effect of Cox-2 Inhibitors.

The FDA panel's chairman says patients taking Cox-2 Inhibitors should not panic. But until all safety questions are answered, the only people who should take the drugs are those with arthritis -- the single condition for which the drugs have been approved.

Five of the 10 people who died suffered from gastrointestinal bleeding or ulcers. Of the other deaths, two were attributed to heart attacks, one to drug interaction, one to a kidney disorder -- and a fifth cause remains undetermined.

"It's too early to reach any conclusions about the drug's safety," an FDA spokesman tells CNN.

The deaths and complications figured in the FDA's adverse-events report, which is filed quarterly. Reports of problems are provided by pharmaceutical companies, doctors and patients.

"There is no indication these deaths and complications were caused by the use of Celebrex," says Scarlett Foster, a spokesperson for Searle & Co., a subsidiary of Monsanto Company. "Before coming to any conclusions, we need to look at other medical conditions that could have contributed to these events."

Patient information materials provided by Searle & Co. also state stomach ulcers can occur in patients using Celebrex without the problem being evident. So patients and their doctors should watch for signs and symptoms of stomach bleeding.