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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Allergenic Extract – Peanut (Arachis hypogaea) - For Diagnostic Use Only by ALK-Abelló: Voluntary Lot Withdrawals - Due to Increased Postmarketing Adverse Event Reporting of False Negative Skin Test Results
AUDIENCE: Allergy and Immunology, Health Professional, Patient
ISSUE: Four lots, 0004014634, 0004014635, 0004218744, and 0004218745 of Allergenic Extract – Peanut (Arachis hypogaea) - For Diagnostic Use Only, manufactured by ALK-Abelló, Inc. have been voluntarily withdrawn by the manufacturer due to increased postmarketing adverse event reporting of false negative skin test results, with some cases reported of life-threatening anaphylaxis from subsequent peanut exposure.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: As with all non-standardized allergenic extracts, no U.S. standard of potency exists for this product. Since there are no specifications for the peanut allergen content of non-standardized peanut allergenic extracts, negative testing should be considered carefully in context.
RECOMMENDATIONS:
- Examine your stock immediately to determine if you have any product from these lots.
- If you have product from these lots,
- cease use immediately.
- contact the company to return the affected product and to receive replacement product.
- 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.
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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.
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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.
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