FDA Warns About Anaphylaxis After False Negative Allergen Tests

The US Food and Drug Administration (FDA) has issued a warning about the potential for patients to experience anaphylactic reactions after a negative skin test with any allergenic extract used to diagnose food allergies.

The FDA is requiring that an anaphylaxis warning after false negative food allergen skin test results be added to the labels of these products in light of reports to the FDA’s Adverse Event Reporting System (FAERS), according to a March 3 statement.

The action follows the recognition of an increase in adverse event reports of false negative test results with specific lots of “ALK-Abello’s Allergenic Extract-Peanut (Arachis hypogaea) – For Diagnostic Use Only.” Some of these reports “were associated with life-threatening anaphylaxis from subsequent exposure to peanut,” according to the statement. “FDA determined that the risk of anaphylaxis following false negative food allergen skin test results is applicable to all allergenic extracts for the diagnosis of food allergies,” the statement notes.

To date, four lots of allergenic extracts have been voluntarily withdrawn from the market by the manufacturer, in November and in December 2022, and should not be used.

Although some allergenic extracts are standardized, those used in the diagnosis of food allergy currently licensed by the FDA for use in the United States are nonstandardized, so potency may vary by lot.

The FDA advises healthcare professionals to consider confirming a negative skin test with serologic testing for peanut-specific IgE or conducting a medically supervised oral food challenge in patients, “based on the patient’s clinical history and the index of suspicion.”

The FDA also urges patients to discuss negative food allergen skin test results with their healthcare providers to determine the possible need for additional testing and to review the symptoms of a severe allergic reaction.

Any adverse events or side effects associated with allergenic products should be reported to the FDA via the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Heidi Splete is a freelance medical journalist with 20 years of experience.

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