.This is an update of a post on Allergy Drops, or Sub-Lingual Immuno-Therapy (SLIT) that I wrote over a year ago.
Simply defined, SLIT is the use of Allergy DROPS placed under the tongue (hence the connection to the pic of Einstein sticking out his tongue) as an alternative to Allergy SHOTS (Sub-Cutaneous Immuno-Therapy, or SCIT).
Allergy Drops are still not FDA-approved as a treatment for allergies in the U.S., as of August, 2011.
Despite dozens of clinical trials that demonstrate the safety and efficacy of allergy drops to treat allergies.
Despite having been used successfully in Europe for decades, and with a safety record that is superior to allergy shots. For these reasons, allergy drops account for over 50% of allergy treatment in Europe.
Does Lack of FDA Approval Matter?
The practice of using a medication to treat something that the FDA has not approved is called “off-label”.
The practice is not illegal. The practice is not unethical.
It is important to realize that nearly every physician uses at least one medication for an off-label use.
In pediatrics, more than half of the medications used in the hospital are used off-label; in the Pediatric ICU, that number approaches 90%!
Those physicians are not doing anything wrong.
They are simply using the available tools (medications) for the optimal health benefit of their patients. And there are simply no available data from clinical trials. Without that, the FDA will not approve a treatment method, no matter how many physicians use it, regardless of the years in use. As just one example, take the many common uses of aspirin that will never be approved by the FDA.
The important consideration is that the off-label use in question has become “standard of care.”
That is, a group of physicians (Pediatric ICU doctors, for example) have reviewed all of the available treatment options, assessed the uses of a medication in adults, included any available data from use in children, and they have concluded that off-label use of a particular medication has potential benefits that outweigh the potential harm.
They are working in their patients’ best interest; they are their patients’ advocates.
The off-label use of a medication often has lower risk than alternative medications that have been FDA-approved.
Yes, It Matters (but not for the reason you’re thinking)
Where it really matters is for payment of treatment.
Insurance programs will refuse to pay for treatment options that are not FDA-approved. They call it “investigational,” as if your physician is experimenting on you.
With dozens of clinical trials demonstrating safety and effectiveness, and decades of successful use in Europe, are allergy drops really experimental?
If you elect a non-FDA-approved treatment, you must pay out of pocket.
Here is a link to the wording of a typical insurance policy (BlueCross BlueShield of Montana) with regard to SLIT: https://www.bcbsmt.com/MedReview/Policies/SublingualImmunotherapy/v101.aspx
Out of pocket.
To get some sense of what the out-of-pocket costs are, take a look at the link to Dr. Chang’s site in Resources, below.
Are Allergy Drops Safe?
Yes, They Are Safe
There has been only a single case of anaphylaxis (severe allergic reaction) reported for allergy drops. (Dunsky EH; Goldstein, MF; Dvorin, DJ; Belecanech, GA (2006). “Anaphylaxis to sublingual immunotherapy”. Allergy 61 (10): 1235)
As of July 2009 there had been no deaths reported from SLIT (allergy drops), despite many millions of doses taken (again, mostly in Europe). SLIT has been around for over 100 years (in fact, was developed prior to SCIT!), but has only been in widespread use (Europe) since the 1990’s.
In contrast, allergy shots have been associated with dozens of anaphylactic reactions, although this treatment has been used for 100 years. (Cooke, RA, Vander Veer, A Jr. Human sensitization. J Immunol 1916; 1:201). Allergy shots have even resulted in some deaths. For example, in 1986 there were 26 deaths (for England alone) related to allergy shots reported over a 10-year period (CSM Update: Desensitising vaccines. Br Med J (Clin Res Ed) 1986; 293:948).
Let’s compare Allergy Shots to Allergy Drops
Allergy Shots versus Allergy Drops
|Allergy Shots||Allergy Drops|
|Method of Administration||Shot in the Arm(s)||A Drop Under the Tongue|
|Risk of Anaphylaxis||Small||None Reported|
|Adverse Reactions||Multiple (Swelling, Itching, Hayfever, etc.)||Nausea, Itching/Swelling/Tingling in the Mouth|
|Physician Visit Required?||Weekly for Years||Every 6-12 Months|
|Allergy Testing Required||Yes (every 2-3 years as needed)||Yes (every 2-3 years as needed)|
|Insurance Coverage for Allergy Testing||Yes for Most Insurances||Yes for Most Insurances|
|Contraindications?||On beta-blocker medication, history of anaphylaxis, young children, asthmatics in our practice, pregnancy||Less than 3 years of age, asthmatics in our practice, on beta-blocker medication, pregnancy|
|Duration of Treatment||3-5+ years||3-5+ years|
|Treatment Frequency||Every 1 to 4 weeks||Daily (one drop 3 times a day)|
|Treatment Location||Physician Office on Build-Up; Home on Maintenance||Home|
|FDA Approved?||Yes||Off-Label (Currently Pending)|
|Cost||Per Insurance Carrier||Out-of-Pocket|
If you have not checked out Dr. Chang’s site, I urge you to do so!! I endorse his website as the best ENT education site on the web. He even has a site dedicated to allergy drops: www.AllergyDrop.net
Who Are Allergy Drops Good For?
Allergy Drops are great for:
- very sensitive people
- anyone with a needle-phobia
- anyone with chronic conditions
- anyone with multiple allergies
So, if you or your child are on this list, ask your allergist about Allergy DROPS.
Image Credit: Albert
ENT Today Article, SLIT vs SCIT: http://www.enttoday.org/details/article/498209/SLIT_vs_SCIT_A_QA.html
A History of SLIT, from the Renaissance Allergist: http://angryallergist.squarespace.com/the-angry-allergist-journal/2009/2/3/sublingual-immunotherapy-slit-the-early-studies.html
Fauquier ENT SLIT Site: http://allergydrop.net/
For out-of-pocket expenses of Allergy Drops, visit Fauquier ENT’s site: http://www.fauquierent.net/billing.htm
Hi, I’m Russell Faust, author of this medical education blog.
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