Is Sublingual Immunotherapy for Allergies FDA Approved

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Sublingual Immunotherapy (SLIT) or popularly known as “allergy drops” is a method to treat allergy symptoms. The basic underlying factor for SLIT has to do with allergic sensitivity. Supposedly, the allergy drops help to improve the symptoms and as a result, the allergic sensitivity improves too. There is not much difference between allergy cure injections and the allergy drops – the method differs only in its administration.

In a study published in Allergy 2007: 62: 943 – 948, a three-year study of the subcutaneous immunotherapy revealed marked improvement in the development of asthma in children with allergic rhinoconjunctivitis. Reviewing all the research papers on allergy and published in the Journal of Allergy and Clinically Immunology, 35% of studies resulted in significant reductions in medications and symptoms.

Even though the SLIT for allergies is still not popular in the US, 90% of the countries in Europe use allergy drops for cure. Typically, one needs about 3 months of dosage for the SLIT to be effective for long-term.

Who Benefits from SLIT?

Most allergy sufferers will benefit from SLIT but those who cannot tolerate or cannot respond to allergy shots like children, asthmatics, highly sensitive people, and those with sinusitis and multiple allergy conditions benefit from SLIT more than others. Using allergy drops is safe for patients of any age. Some of the advantages of allergy drops are given below:

• Patients have the convenience to take the allergy drops within the comforts of home.

• Patients who begin with allergy drops report reduction in allergy symptoms and thus reduction in the intake of other medications to control allergy symptoms.

• Patients do not need to visit clinics often. A visit once every 6-12 months is more than enough. This means there is lower medicinal cost and fewer number of clinic visits.

• Patients feel better and report fewer clinic visits or hospitalizations.

The Debate

Even though the allergy drops are beneficial, there is a pertaining question – is sublingual immunotherapy for allergies FDA approved? To know the answer, first thing one needs to understand is that the allergy drops uses the same antigens, which are prescribed by physicians and therefore, it is well within the legal permission. In fact, the process of preparing the antigens is same as in allergy injections and allergy drops. As mentioned earlier, only the route of administration differs.

Why the debate about “Is sublingual immunotherapy for allergies FDA approved?” erupts is because the antigens labeled by the FDA for use should be imparted through injections only. But when one is using the antigens in the allergy drops, it falls under the category of an “off-label”. Off-label is those medications which do not have the legal permission for use yet but is widely used for several cures.


Central Coast Allergy & Asthma: Sublingual Immunotherapy FAQ

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