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Are sublingual immunotherapy for allergies fda approved?
2 Answers » - Asked by admin - on December 31st, 2009 at 3:44 am - filed under Allergies
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Hello,
The FDA’s Center for Biologics Evaluation and Research (CBER) regulates “allergenic extracts” in the United States. (see http://www.fda.gov/BiologicsBloodVaccines/Allergenics/default.htm). Allergenic extracts are labeled for diagnostic skin testing and for allergen immunotherapy administered by injection, also known as Subcutaneous Immunotherapy (SCIT). Legitimate sublingual immunotherapy is prepared with the same FDA licensed allergenic extracts, but because it is administered under the tongue (sublingual), it is technically an “off-label use” of an approved biologic. With appropriate scientific evidence, off-label use is a common and accepted practice.-JL
No. The FDA has not yet approved SLIT (sublingual immunotherapy). Clinical studies are underway in the US to gain FDA approval. The extracts commonly used in SLIT have long ago been approved, for skin testing and allergy shots.
Allergy shots, or subcutaneous immunotherapy (SCIT), has had high efficacy, and has been safe for most patients, with few deaths reported annually in the US. Allergy shot mortalities led the United Kingdom to essentially outlaw allergy shots, by requiring that several hours following an allergy shot, the patient be observed in a hospital setting able to provide emergency treatment for reactions to the shots.
Subsequently, there has been renewed interest in Europe for a safer modality of immunotherapy. SLIT is now widely utilized in Europe, where there have been no reports of deaths from sublingual allergy drop therapy. The FDA expects the medical practitioner to offer alternatives, after evaluating various modalities of treatment, including off-label (non FDA approved) therapy when it appears to be in the best interest of the patient.
In fact, the World Health Organization has stated that SLIT is a viable alternative to allergy shots.