CELEBREX: FDA, Experts Dispute Link to Deaths
The FDA is discounting concerns raised by yesterday's Wall Street Journal article on 10 deaths linked to Monsanto Co.' Cox-2 painkiller Celebrex. The 10 fatalities and 11 cases of gastrointestinal hemorrhage are "absolutely uninterpretable," said Dr. Steven Abramson, who chairs the FDA's arthritis advisory panel. He said, "Were they taking an aspirin a day? Low doses of aspirin can cause acute hemorrhaging. We don't know what over-the-counter medications these people were taking." A FDA spokesperson said, "We don't believe this represents a signal at this point, because you have to take into account the 2 million [Celebrex] prescriptions" since its introduction three months ago. She added, "We would continue to monitor this and look at the gastrointestinal effects" (Reuters/Boston Herald, 4/20). Dr. Lee Simon of Beth Israel Deaconess Medical Center, "who headed one of the trials that led to FDA approval of Celebrex," said, "Unequivocally, there is no evidence to link the use of Celebrex with any of these events." Noting he "has served as a paid consultant" to Monsanto, Silver said "there is no reason for any patient to stop using the drug. ... If there is a problem that needs to be addressed, we will do that in terms of label changes or warnings or other steps" (Lasalandra, Boston Herald, 4/21).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.