FDA: 'Premature' to draw Vioxx conclusions

Medical Marketing and Media, Jun 2000 by Dickinson, James G

The FDA Office of Drug Evaluation V Director Robert Delap says it is "premature" to draw conclusions from recent clinical data on Merck's arthritis drug Vioxx (rofecoxib), which showed that patients taking the drug suffered significantly more heart attacks than occurred in patients taking the NSAID naproxen.

The data came from a lengthy study on gastrointestinal outcomes among 8,000 rheumatoid arthritic patients that Merck conducted to show (successfully) that Vioxx produces fewer GI disturbances than naproxen. Delap told Dickinson's FDA Webview that the cardiac events data from the study that the agency has seen are preliminary and he is expecting more data to be submitted shortly. He said the agency will continue to monitor Vioxx drug experience reports, and that for now the drug is appropriately labeled.