FDA Mandates Stronger Warning on Asthma Drug Xolair

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Persistent asthma (as opposed to intermittent asthma) carries a high risk of exacerbations and the need for resultant medical treatment.

In some people, asthma is caused by an allergic reaction gone awry: The immune system stimulates the production of IgE antibodies. Subsequent exposure to the allergen or allergens causes the IgE antibodies to set off an inflammatory response, which leads to the wheezing and other breathing difficulties associated with asthma.

Xolair is a monoclonal antibody that interrupts this potentially life-threatening process at the start. It is the first biologic approved for asthma, and is given by injection once a month.

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The drug already has a black box warning for a possible raised risk for malignancies, although that link is not definite, Horovitz said.

"The majority of physicians who prescribe Xolair are allergists or pulmonologists, and most are aware of this potential adverse reaction," said Dr. David Weldon, director of allergy and pulmonary lab services at Scott & White Clinic, in College Station, Texas. "I think more allergists are going to equip patients with EpiPens [anaphylaxis remedies] to be able to utilize them, based upon the black box warning. It would be prudent that anybody who's on Xolair make sure they get one of the commercially available epinephrine sources like an EpiPen."

Although many patients consider the drug only slightly short of a miracle, some cases of anaphylaxis have been reported following administration of the drug. These reactions have occurred at a rate of about one in 1,000 patients, the FDA said.

The new warning discusses the possibility of patients developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, the reaction may occur up to 24 hours after administration of the drug.

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