CELEBREX: Ten Deaths Linked to Monsanto’s Blockbuster
Monsanto Co.'s blockbuster Cox-2 inhibitor Celebrex, "touted as much safer than other painkillers," has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhage since it hit the market three months ago, the Wall Street Journal reports. According to reports submitted to the FDA, half of the people who died suffered from gastrointestinal bleeding or ulcers, and the remaining deaths were attributed to other causes. All 11 hemorrhage cases required hospitalization, and an additional six reports of abdominal swelling have been filed with the FDA. Prescriptions for Celebrex are soaring, the Journal reports, with 2.5 million dispensed in just three months, making it difficult for the FDA to pinpoint risk. "We won't be able to reach conclusions about its relative safety compared to other painkillers until more research is done," said Robert DeLap, director of an FDA office of drug evaluation. "Do we think there's a signal that the product poses some special risk? No," he said. Dr. Steve Geis, Monsanto's vice president for arthritis research, said the results were within the projected safety profile and the number of adverse incidents were low, given the large numbers of patients. "We really feel the drug is performing as expected," he said, noting that the patients who experienced difficulty with Celebrex had other illnesses and were taking other drugs that "may contribute to any potential side effects." However, consumer watchdog Public Citizen pounced on the reports, saying the "side effects sound disturbingly similar to Melozicam, a superaspirin marketed in Britain" that caused nearly 550 gastrointestinal adverse affects within its first 21 months (Sharpe, 4/20).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.