Health

FDA approves drug to treat Crohn's disease

NEWS IN BRIEF — Posted March 19, 2007

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The Food and Drug Administration approved a new injectable medication Feb. 27 to treat adult patients with moderately to severely active Crohn's disease.

The drug, Humira (adalimumab), will carry a black-box warning to indicate that it has been associated with serious, sometimes fatal infections, including tuberculosis, opportunistic infections and sepsis. Before initiating Humira treatment, physicians should evaluate patients for tuberculosis risk factors and test them for latent TB infections.

Other serious side effects included lymphoma. The most frequent adverse events included upper respiratory infections, sinusitis and nausea.

"Humira has been shown to reduce signs and symptoms and to induce and maintain clinical remission of Crohn's disease in patients who have had an inadequate response to conventional therapy and in those patients who did not benefit from treatment, or who were intolerant to previous treatment with Remicade, also known as infliximab," said Douglas Throckmorton, MD, deputy director of FDA's Center for Drug Evaluation and Research.

Treatment requires subcutaneous injections to initiate treatment and maintenance treatment administered as one injection every other week.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/03/19/hlbf0319.htm.

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