Joint Pain Forum – News you can use!
seeking FDA approval for Arcoxia
March 21, 2007
BY K. KERR; Newsday
for arthritis?... Merck seeking FDA approval for Arcoxia, a chemical
relative of Vioxx, which was linked to heart attacks.
In a bid
to recapture a piece of the arthritis pain-relief market, Merck
& Co. is seeking government approval for Arcoxia, a chemical
relative of Vioxx, the drug pulled off drugstore shelves in 2004 after
being linked to heart attacks.
last full year on the market, Vioxx brought in about $2.5billion in
sales. If the Food and Drug Administration approves Arcoxia, Merck
could recoup some of those sales.
12 an FDA advisory panel will consider approval of Arcoxia for
osteoarthritis; it is already sold in 62 other countries. The FDA
usually follows advisory panel recommendations.
like Vioxx, belongs to a group of drugs called COX-2 inhibitors, which
block an enzyme that causes arthritis pain. Celebrex is the only COX-2
drug still on the market.
study of 34,000 patients compared Arcoxia to diclofenac, a
nonsteroidal, anti-inflammatory drug sold mostly outside the United
States under the brands Cataflam and Voltaren.
Merck says Arcoxia users had somewhat
fewer heart attacks than diclofenac users but were more likely to
develop hypertension. Arcoxia also led to fewer upper gastrointestinal
problems, Merck says.
Loder, a Merck spokesman, said, "We believe Arcoxia has the potential
to become a valuable treatment option for many Americans suffering from
Porges, a rheumatologist at St. Francis Hospital in Roslyn,
participated in a Merck clinical trial for Arcoxia several years ago.
Merck must prove Arcoxia's cardiovascular risks are no greater than
those posed by other anti-inflammatory drugs. "If the drug showed no
significant increase in hypertension or edema relative to standard
anti-inflammatories, I would think the drug [Arcoxia] would be safe,"
Porges said he'd prescribe Arcoxia only for patients whose medical
history - such as bleeding problems - precludes other pain drugs.
Chatpar, chief of rheumatology at Plainview Hospital, also tested
Arcoxia for Merck and said most of his patients "did remarkably well.
However, "COX-2 inhibitors in general have to be used with caution
now," he said, noting the need for blood pressure screening. "I think
the same will hold true for Arcoxia."
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