Thursday, January 03, 2008

FDA brief shows CV risk with etoricoxib. Part 1

Capital of the United States DC - An FDA memo
shows that there are concerns over an gain 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 International organisation and elsewhere, and lumiracoxib (Prexige, Novartis), which hasn’t been launched anywhere in the INSTANCE OFterrestrial planet yet.

The
memo, posted on the FDA website on Friday, contains detailed briefing
documents for the FDA sense of hearing next week, which will “discuss
the work-clothes 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 meaning, whether these new agents
should be launched.
Etoricoxib “worse than each comparator”.

The
comments on etoricoxib don’t spoken communication out a rosy time to
come, although this result has already been deemed “approvable” by the
FDA.
Etoricoxib has a “marginal gastrointestinal (GI) point,” 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 writer Dr Joel Schiffenbauer.
Also, the data in the new drug action (NDA) suggest a CV prophylactic device incitation.



This is a part of article FDA brief shows CV risk with etoricoxib. Part 1 Taken from "Generic Arcoxia (Etoricoxib)" Information Blog

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