There are currently no documented cases of death or life-threatening systemic reactions that have been resulted from SLIT treatments for inhalant sensitivities. Although very rare, allergy shots have been known to cause life-threatening systemic reactions. On the other hand, SLIT has been safely practiced by healthcare providers all over the world for more than 40 years.
Is Sublingual Immunotherapy FDA-Approved?
The sublingual route of allergen extract administration has not been approved or cleared by the FDA.
Sublingual immunotherapy is an off-label use of allergen extracts that have been FDA approved for use in subcutaneous immunotherapy.
Although sublingual immunotherapy is not FDA-approved, the superior safety profile of sublingual immunotherapy (SLIT) versus allergy shots (subcutaneous immunotherapy) is well documented in peer-reviewed literature.
Immunotherapy (subcutaneous and sublingual) is contraindicated for patients with:
- unstable coronary artery disease
- autoimmune disease
- unstable asthma
- asthma having peak flow or FEV1 below 80% of predicted value
- patients under 5 years of age
- patients using beta-blockers
- severe psychological disorders
- pregnant women