Arcoxia, Merck's new painkiller, comes up for review by an FDA advisory committee tomorrow. The Wall Street Journal Health Blog reports that a memo released yesterday "sets up the likely standard for Arcoxia’s review." Memo excerpt:
“…a new product that appears to have an increased overall risk profile for CV disease, particularly beyond that seen with other drugs, would not be appropriate for marketing unless the product fills an unmet medical need for a particular patient population that has no relatively safer approved products available to them, and provides a reasonable risk to benefit balance for that population.�
And the Public Citizen Health Research Group - a watchdog agency - asked the FDA " to order Pfizer to immediately stop its misleading 2 ½ minute television advertisement for Celebrex that began airing on April 2nd."
Public Citizen faults the Celebrex ad for:
* asserting, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are no greater than those of any of the other non-steroidal anti-inflammatory (NSAID) painkillers; andPosted by schwitz at April 11, 2007 08:31 AM | TrackBack* claiming that there are overall gastrointestinal benefits with Celebrex over two popular, over-the-counter painkillers, while trying to downplay the risk of serious stomach and intestinal problems such as bleeding and ulcers that applies to Celebrex and all other NSAIDS.