U.S. FDA staff says Merck's Arcoxia data mixed
(Adds details from FDA staff summary, Merck comment)
WASHINGTON, April 10 (Reuters) - A Merck & Co. Inc. (MRK.N) study showed the risk of heart attacks and other cardiovascular problems for patients who took pain reliever Arcoxia was similar to that with the older drug diclofenac, U.S. regulatory reviewers said in documents made public on Tuesday.
A Food and Drug Administration staff summary also said smaller and shorter studies showed Arcoxia, Merck's successor to withdrawn arthritis pill Vioxx, appeared to carry greater cardiovascular risk than the pain reliever naproxen or a placebo but less risk than other non-steroidal anti-inflammatory drugs (NSAIDs).
The staff summary, released ahead of an advisory panel review, also said Arcoxia patients in Merck's large safety study dropped out at a higher rate because of problems related to high blood pressure.
Merck is seeking FDA approval to market Arcoxia in the United States. The drug is sold in 63 countries.
An advisory panel of experts from outside the FDA meets Thursday to consider whether to recommend Arcoxia for approval. The agency usually follows advisory panel recommendations.
In a separate summary, Merck said Arcoxia was less likely to cause gastrointestinal problems such as bleeding that can be complications from NSAIDs and its risks were "consistent" with other drugs in the class.
The FDA staff analysis said the rate of complicated gastrointestinal problems, such as intestinal perforations or obstructions, was about the same for Arcoxia and diclofenac.
((Reporting by Lisa Richwine, editing by Steve Orlofsky; Reuters Messaging: lisa.richwine.reuters.com@reuters.net, Phone: 202-310-5691)) Keywords: MERCK ARCOXIA/
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