On January 31, FDA approved the first drug to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. The drug, Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] may be given to individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy. However, FDA warns that those who take Palforzia must continue to avoid peanuts in their diets.
Peanut allergy is a condition in which the body’s immune system mistakenly identifies even small amounts of peanut as harmful. Allergic reactions to peanut are unpredictable in occurrence and in how they present. Physical symptoms can develop within seconds of exposure and may include skin reactions (e.g., hives, redness or swelling), digestive discomfort, or more dangerous reactions, such as constriction of the throat and airways, and loss of adequate blood flow to vital organs of the body. As per the FDA press release, Palforzia may be used to mitigate reactions, but cannot be used for the emergency treatment of allergic reactions.
According to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, peanut allergy affects approximately 1 million children in the US. Only 1 out of 5 of children will outgrow their allergy. There is no cure for peanut allergies and therefore those who are allergic must strictly avoid exposure. Hence, the importance of allergen labeling. As our readers know, under the Food Allergen Labeling Consumer Protection Act (FALCPA), all packaged foods are required to label the presence of a “major food allergen.” FALCPA identifies 8 foods or food groups as the “major food allergens,” including peanuts. The 8 major food allergens identified by FALCPA account for over 90% of all documented food allergies in the US and represent the foods most likely to result in severe or life-threatening reactions.