WEDNESDAY, Nov. 7 (HealthDay News) -- Xeljanz (tofacitinib) has been approved by the U.S. Food and Drug Administration to treat moderately to severely active rheumatoid arthritis (RA) among people who can't tolerate, or haven't been helped by, the drug methotrexate.
About 1.5 million Americans have RA, the FDA said in a news release.
A twice-daily pill, Xeljanz is designed to block Janus kinases, 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 serious infections, including opportunistic infections triggered by a suppressed immune system, 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 rheumatoid arthritis.
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