FDA MedWatch - All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication

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TOPIC: All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication - FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information 

AUDIENCE: Allergy and Immunology, Pediatrics, Health Professional, Patient 

ISSUE: In 2022, during safety monitoring of FDA Adverse Event Reporting System (FAERS) data, FDA became aware of increased postmarketing adverse event reporting of false negative skin test results with certain lots of ALK-Abello’s Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only. Some of these reports of false negative test results were associated with life-threatening anaphylaxis from subsequent exposure to peanut.

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. Therefore, the FDA initiated safety labeling changes for all allergenic extracts for the diagnosis of food allergy to include a Warning regarding anaphylaxis following false negative food allergen skin test results.

For more information about this alert, click on the red button Read Alert below.

BACKGROUND: Allergenic extracts for the diagnosis of food allergy are sterile liquids that are manufactured from natural substances (e.g., peanut) known to elicit allergic reactions in susceptible individuals. Among allergenic extracts, some are standardized; for these products there is an established method to determine the potency (or strength) of the product on a lot-by-lot basis. For other allergenic extracts there is no U.S. standard of potency, and these are called "non-standardized." All allergenic extracts for the diagnosis of food allergy currently licensed by FDA for distribution in the United States are non-standardized.

RECOMMENDATIONS: 

Information for Patients

• Some people who have had false negative food allergen skin test results, have experienced anaphylaxis after subsequent exposure to the food allergen.
• Discuss negative food allergen skin test results with your healthcare provider to determine if any further testing is needed to evaluate for food allergy.
• Symptoms of a severe allergic reaction (including anaphylaxis) that may require emergency treatment can include:
  • Difficulty breathing
  • Swelling of the face and throat
  • A fast heartbeat
  • A bad rash all over the body
  • Dizziness and weakness

Information for Healthcare Professionals

• Some people who have had false negative food allergen skin test results, have experienced anaphylaxis after subsequent exposure to the food allergen.
• Based on the patient’s clinical history and the index of suspicion, healthcare providers may wish to confirm negative skin testing with serologic testing for peanut-specific IgE or a medically-supervised oral food challenge.¹
• Do not use product from the four lots voluntarily withdrawn by the manufacturer that are listed on the FDA website: Voluntary Lot Withdrawals of Allergenic Extract – Peanut (Arachis hypogaea)- For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

[03/03/2023 - FDA Safety Communication - FDA] 

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