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Report Submitted To FDA On Risks Linked To Celebrex MONTREAL, QC -- April 21, 1999 -- Reports submitted to the United States Food and Drug Administration (FDA) say 10 deaths and 11 cases of gastrointestinal (GI) bleeding have been linked to use of the drug Celebrex, according to an article in The Wall Street Journal. The drug’s maker, Monsanto Co.’s G.D. Searle & Co., has touted Celebrex as being safer than other painkillers. The Journal article claims that five of the 10 people who died had GI bleeding or ulcers, two of the deaths were due to heart attacks, one to drug interactions and one to a kidney disorder. No cause was given for the other fatality. Six other reports involved abdominal pain or swelling and most of the cases of abdominal bleeding required hospitalization, according to the Journal. According to the FDA, it is difficulty to evaluate the significance of these reports due to the large number of Celebrex prescriptions. Since the drug came on the market 13 weeks ago, 2.5 million prescriptions have been written. In light of the research currently available, there is no special risk associated with Celebrex and more research will be required before a decision is made about its safety, an official of the FDA told the Journal. Celebrex is indicated for the treatment of arthritis symptoms. Celebrex was tested in clinical trials that involved over 13,000 patients and healthy volunteers enrolled in more than 50 different clinical studies in 23 countries world-wide. In clinical trials, Celebrex was shown to be as effective as the maximum prescription-strength non-steroidal anti-inflammatory drugs (NSAIDs) naproxen and ibuprofen in treating arthritis pain and inflammation. In OA patients, Celebrex improved pain, stiffness and patient functions, such as walking, bending and getting in and out of a car. The drug’s maker claims the research shows Celebrex was associated with significantly fewer upper GI ulcers than traditionally-used arthritis medications naproxen and ibuprofen. Celebrex is the first arthritis medication to target and block the COX-2 enzyme that plays a role in causing arthritis pain and inflammation, without blocking the COX-1 enzyme that protects the gastrointestinal system. E-mail this page to a friend or colleague! To print, use this version