Tuesday, September 25, 2007

FDA legal instrument shows CV risk with etoricoxib and state of mind over lumiracoxib.

Feb 7, 2007 WA DC - An FDA memo shows that there are concerns over an addition in cardiovascular risk with 2 new COX-2 selective inhibitors that are awaiting content in the US— etoricoxib  (Arcoxia, Merck & CO), which is already available in European Union and elsewhere, and lumiracoxib (Prexige, Novartis), which hasn’t been launched anywhere in the people yet [ 1 ]. The memo, posted on the FDA website on Friday, contains detailed briefing documents for the FDA range next week, which will “discuss the coverall benefit-to-risk considerations for COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs] and related agents.” Among the questions to be addressed is whether these drugs should continue to be marketed and, by substance, whether these new agents should be launched. Etoricoxib “worse than each comparator” The comments on etoricoxib don’t mental condition out a rosy good, although this outcome has already been deemed “approvable” by the FDA.
Etoricoxib has a “marginal gastrointestinal (GI) reward,” but this is seen mainly when it is compared with naproxen in osteoarthritis, and this welfare is entirely lost in patients who are taking low-dose aspirin for cardiovascular prophylaxis, writes FDA author Dr Joel Schiffenbauer .
Also, the data in the new drug computer program (NDA) suggest a CV device incitation. In point in time of cardiovascular prophylactic, etoricoxib appears to be “worse than each comparator.” For CV-related deaths, there appears to be an immoderation of cases due to etoricoxib compared with medication, although the view to medicine is limited, the reassessment comments.
However, the data related to naproxen clearly show an overabundance of CV mortality rate related to etoricoxib (and this is consistent with what has been seen in other studies comparing naproxen with rofecoxib [Vioxx, Merck & Co], which was withdrawn from the industry because of an increased cardiovascular risk.) Boilers suit, the product of pooled cardiovascular/thromboembolic events is similar in all groups, the referee says, but when cardiac events are specifically examined, there is an process with etoricoxib compared with medicament, naproxen, and diclofenac. “This is especially true for myocardial infarctions” in the EDGE musical composition, which compared etoricoxib with diclofenac in 7000 patients.
This is a part of article FDA legal instrument shows CV risk with etoricoxib and state of mind over lumiracoxib. Taken from "Generic Arcoxia (Etoricoxib)" Information Blog