(WXYZ) — There’s good news for people with multiple food allergies. The Food and Drug Administration expanded the use of a medication called Xolair to reduce allergic reactions.
The approval was based on a study.
The medication Xolair does not eliminate food allergies. So, it doesn’t grant people the freedom to freely eat the foods they’re allergic to. What it does do is reduce the impact of accidental exposure. This is a significant concern for people with food allergies and their families, especially during social events or dining out, where accidental exposure could be life-threatening.
Now, Xolair is the brand name for omalizumab. Omalizumab was first approved in 2003 for treating moderate to severe allergic asthma. The expanded FDA approval was based on a double-blind, placebo-controlled study that included 168 pediatric and adult participants.
All were allergic to peanuts and at least two other foods, including milk, eggs, wheat, cashews, hazelnuts or walnuts. Over 16 to 20 weeks, participants were randomly assigned either Xolair or a placebo.
The findings revealed that 68% of those given Xolair could consume about 1/2 teaspoon of peanut protein without experiencing moderate to severe allergic symptoms like hives, vomiting or coughing.
However, 17% of Xolair recipients experienced no significant change. The study abstract reported similar outcomes for tree nuts, wheat, milk, and eggs. That is why the FDA recommends that allergens be intentionally avoided while on this medication.
Xolair is in the class of drugs called monoclonal antibodies. It binds to immunoglobulin E, which is an antibody type that triggers allergic reactions. It can block the body’s natural response to allergens.
As for side effects, the most common ones observed were fever and injection site reactions. The FDA noted that Xolair carries warnings and precautions, such as malignancy, joint pain, rash, parasitic or worm infection and abnormal laboratory test results.
The drug carries a boxed warning for anaphylaxis, a severe, potentially life-threatening allergic reaction that may compromise breathing, lead to a significant decrease in blood pressure, and impact heart rate. It can be fatal and must be treated immediately with epinephrine.
On a positive note, this drug could potentially help 17 million Americans with serious food allergies. It’s approved for certain adults and children aged one or older. It could possibly ease the stress families face due to severe food allergies and let them enjoy more activities outside of home.