고름쟁이만 반대

The report may mislead to the readers. The sale of coxibs will be dropping dramatically in near future. Also, their place in therapy will be very limited given the recommendations on black box warning and results of recent studies in NEJM. In my opinion, coxibs are one of the drug classes that have been overused without solid evidence- I cannot understand how CLASS trial could be published in JAMA, which only contained the first half of the study. Anyway, below is from theheart.org regarding the FDA committee discussion over coxibs. Their discussion is quite different from what Dailypharm is reporting here. Regarding valdecoxib: Committee members questioned whether valdecoxib (Bextra®, Pfizer) should have ever been approved at all, considering the "paucity of data" and the additional concern over adverse skin reactions. "It seems almost inconceivable to me that someone would prescribe this drug instead of celecoxib," Dr. Alastair Wood said. He added that with such a lack of data, there is no evidence that it is safer or more harmful. But in the end, the committees voted narrowly in favor of the overall risk-to-benefit profile supporting the continued marketing of valdecoxib. Seventeen members voted for and 13 against, and two abstained. "The panel clearly was concerned over the lack of long-term safety data and that was reflected in the unenthusiastic vote for retaining valdecoxib on the market," Dr. Shafer told heartwire in an interview following the meeting. Regarding celecoxib; The committee as a whole decided that while celecoxib should continue to be available, stricter cautions are in order, including a strongly worded black-box warning about thrombotic risk and education materials such as a "Dear Healthcare Professional" letter and patient-education materials. The committees also talked about dose-dependent toxicity and tended to err on the side of doses of 200 mg. Several panelists also urged that direct-to-consumer advertising of celecoxib be halted.