FDA Requires Anaphylaxis Warning for All Allergenic Extracts

On March 3, 2023, the FDA issued a safety communication, announcing that it would require and approve changes to prescribing information labels for all allergenic extracts. The new labels should include an anaphylaxis warning for extracts that test and diagnose food allergies.

According to the safety communication, all manufacturers will be required to include the following warning on their Prescribing Information label under an “Anaphylaxis Following False Negative Food Allergen Skin Test Results” heading:

“False negative skin test results associated with anaphylaxis from subsequent exposure to the allergen have been reported during postmarketing diagnostic use of some food allergenic extracts. Based on the patient’s clinical history and the index of suspicion, healthcare providers should consider confirming negative skin testing with serologic testing by measuring specific serum IgE or with a medically-supervised oral food challenge.”

The announcement explains that the new requirements result from multiple false-negative food allergy tests reported in December 2022. The original notice of the label changes was sent out in January 2023 to ALK-Abello, Greer Laboratories, and Allergy Laboratories. Allergy Laboratories has requested that their biological licenses be revoked and will no longer be affected by these changes.

Data reported to the FDA Adverse Event Reporting System noted that tests using some lots of ALK-Abello’s Allergenic Extract — Peanut (Arachis hypogaea) — For Diagnostic Use Only yielded false negative results.

On December 20, 2022, the FDA released a statement that the company had voluntarily withdrawn multiple lots of the product based on the false negative results. False negatives resulted in numerous cases of anaphylaxis due to peanut exposure. The FDA warns that symptoms of anaphylaxis, including difficulty breathing, swelling of the face and throat, rapid heartbeat, bodily rash, dizziness, and fatigue, may be life-threatening.

Patients with a recent negative allergy test may consider discussing their results further with their provider. Providers are also advised to determine if a negative skin test warrants further serological testing, which may be more accurate. Providers are also urged to avoid using lots of allergen extracts that have been withdrawn.