FDA Approves Immunotherapy Allergy Tablets…Finally

The most exciting news in 100 years has just happened in the field of allergy:

The FDA approved the use of sublingual tablets for the treatment of environmental allergies.

I’m not kidding. It’s been a hundred years since a new form of allergen immunotherapy has been approved. Actually, subcutaneous allergy immunotherapy, or allergy shots, was actually grandfathered into acceptance by the FDA because it was around before there was even the existence of the FDA!

What Took So Long?

This is a great question, which I have been answering my patients for the past 15 years. I have been treating my patients with sublingual allergy drops for over 15 years — way before the FDA gave its blessing. My critics said, “I wouldn’t do what Dr. Mitchell is doing because it’s not FDA approved.” Well, if you want the in-depth scoop on how I came to be one of the earliest physicians to provide sublingual immunotherapy to my patients you need to read my book: Dr. Dean Mitchell’s Allergy and Asthma Solution. I’m not writing this to plug my book, but it does give you an interesting insight into how effective therapies can be put on the shelf for lots of bad reasons.

Dr. Dean Mitchell M.D.

What took so long to get sublingual allergy immunotherapy into the U.S. market?

I divide it up into several categories:

1. Conservative Medicine

Interestingly, medicine as a profession doesn’t like a new medical treatment, unless it is a fancy state of the art surgical procedure. Doctors are conservative by nature, which can be a good thing. However, it is somewhat eerie that many doctors practice medicine with the same method for years, after they have finished their medical training. I always took the view that my medical training was an ongoing endeavor, and whatever leads me to effective treatments in a safe way should be added to my black bag. I knew from colleagues I corresponded with that in Europe they were using sublingual allergy treatment 20 years ago. I gathered all the articles I could find (this was before the Internet), and I was shocked to see that this treatment was very effective and very safe.

2. Disruptive Economics

The medical profession doesn’t like when the status quo of medical reimbursement changes. I give the analogy that physicians were fighting back in the day about oral antibiotics. Previously, antibiotics, such as Penicillin, were given by injection in the doctor’s office. When oral antibiotics came about, the patient just needed a prescription from their doctor. Doctors complained that patients wouldn’t take all the medicine and their infection would worsen. Fifty years later we know this isn’t true.

Allergy drops—safe and effective

Sticking to the Regimen

The exciting option of sublingual allergy immunotherapy is that it opens up allergy treatment outside the doctor’s office and into the patient’s home. This can be a critical advantage because compliance can be easily achieved. I know that in my own practice almost 90% of my patients complete the full course of therapy. It’s very rewarding to be able to see my patients play with pets when previously they couldn’t even go into the same room as a cat or dog. I love it when one of my patients thanks me for making their spring enjoyable again. All of this is accomplished by placing the proper allergy drops under their tongue and sticking to the regimen.

Tablet vs. Drops

I do need to make an important distinction here: the FDA approved sublingual allergy immunotherapy is a high dose tablet, not the liquid drops I use in my practice. Although the tablet has clearly been proven to be effective, its down-side is two-fold: I’m concerned that since there is only one dosage that is high dosage many patients will have adverse reactions. And in fact, the FDA is recommending patients who use this treatment have an epinephrine injector. Also, this tablet is currently only for grass allergen, and this is only one allergen of many significant allergens that I can treat with my sublingual drops.

The jury delivered its verdict: sublingual allergen immunotherapy works. I knew this almost 20 years ago when I saw the results after a year of treating my patients. I’m glad the FDA caught up!

Dr. Dean Mitchell M.D.
Mitchell Medical Group, NYC & Long Island