-- Scott Roberts
WEDNESDAY, Nov. 7 (HealthDay News) -- Xeljanz (tofacitinib) has
been approved by the U.S. Food and Drug Administration to treat
symptoms of rheumatoid arthritis (RA) among people who can't
tolerate, or haven't been helped by, the drug methotrexate.
RA is an autoimmune disease in which the immune system
mistakenly attacks the body. In the case of RA, this leads to
swelling of the joints and nearby tissues. About 1.5 million
Americans have RA, the FDA said in a news release.
A twice-daily pill, Xeljanz is designed to block molecules
involved in joint inflammation, the FDA said.
The drug was evaluated in seven clinical studies of adults with
moderate-to-severe RA. The drug carries a "black box" label warning
of an increased risk of infection triggered by a suppressed immune
system, and tuberculosis and certain cancers.
Other serious side effects could include increased cholesterol
levels and liver enzyme problems, the FDA said. More common adverse
reactions were upper respiratory tract infections, headaches,
diarrhea and nasal inflammation.
Xeljanz is marketed by New York-based Pfizer Inc.
The U.S. National Library of Medicine has more about
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