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| |  Searle Responds to Journal Report On Celebrex Side Effects SKOKIE, Ill. -- April 22, 1999 -- A leading U.S. rheumatologist says there is no evidence in an adverse event report submitted to the U.S. Food and Drug Administration to indicate that there is any danger in using the new arthritis drug, Celebrex(TM) (celecoxib). "After review of the individual cases, I believe there is nothing in the adverse event report that should concern patients," Dr. Lee Simon, a leading rheumatologist from Harvard Medical School, said in a statement released by G.D. Searle, maker of Celebrex. "I will continue to prescribe Celebrex, and patients can continue to use Celebrex with confidence, consistent with their physicians’ advice." G.D. Searle issued the statement in response to a Wall Street Journal story about adverse events among patients taking Celebrex. The statement said the company’s first interest is patient safety. "We take all adverse reaction reports seriously, review them appropriately, and share information with the Food and Drug Administration (FDA)," the statement says. According to the company, Searle’s medical review of the individual 10 reports reported by the Journal indicates no direct causality between Celebrex usage and any of the reported deaths. "Celebrex is already being used by more than 2 million people. There is nothing in the postmarketing reports to alter our confidence in the safety and effectiveness of Celebrex. Our experience shows that the drug is safe and effective when used as prescribed within the label," the statement says.
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