FDA Approves OTC Nasal Steroid

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Intranasal Steroids (INS) have long been the most effective therapy for nasal allergies, and their use is part of the guidelines for the treatment of both allergic rhinitis and asthma. They’ve been in use since I was a child and have always been available only by prescription. Over the past few years, several other countries have made them available without a prescription, commonly called over-the-counter or OTC. The U.S. has now followed suit. The FDA voted 10-6 in favor of allowing the steroid triamcinalone acetonide (TAA) to be sold OTC as an INS. There has been mixed reaction to this in the allergy community and the AAAAI issued a position paper, which was endorsed by the American Academy of Pediatrics, against allowing TAA to be sold as an INS OTC. Overall, I’m in favor of the move, but I do share some of the AAAAI’s concerns.

The AAAAI spends most of the position paper talking about safety concerns, primarily growth suppression in children. Inhaled corticosteroids for asthma have consistently shown a small reduction in growth with long term use, about the length of my fingernail. The data on INS and growth suppression are less clear, but it is still a reasonable concern. Chronic use of INS has also been linked to cataracts and, less clearly, to glaucoma in adults, though the data here are mixed and the findings less robust. Please note that these concerns are for chronic use, not for episodic use. The TAA packaging will advise users to see a doctor for their symptoms if they have to use the spray for more than a couple of months per year, but if experience with other OTC medications holds true here, many folks will not adhere to this advice.

Another concern with OTC TAA has to do with how INS have to be used. Most OTC medications work well on an as-needed basis. In contrast, INS have to be used regularly for several days in order to work well. If you just use them a day here and a day there, you’re just getting the mechanical effect of squirting something wet up your nose. Product labeling will reflect this need, but, again, there are bound to be folks who don’t read and/or don’t follow the directions, and they will be, essentially, spraying really expensive water up their noses.

The AAAAI position paper leaves out what is, for me, a big issue with bringing TAA OTC: the molecule itself. Off the top of my head, there are seven different steroid molecules being used in INS, two of which are generic: TAA and fluticasone propionate (FP). Of all the molecules, TAA is the worst. It has the lowest topical potency and highest bioavailability (read: potential for side effects). I haven’t written a new prescription for TAA or its former branded equivalent in a decade. Making FP OTC would have been a much better option.

Despite these legitimate concerns, I think the FDA was reassured by the experience other countries have had with OTC INS. If used as directed the potential for significant complications is very low. I’m hopeful that other molecules with better risk/benefit ratios will come to market and that competition will result in cost savings for patients while creating added convenience. When that day arrives, allergists and other physicians will still have an important role in counseling patients as to which OTC INS are best for them, much like we do for OTC antihistamines.

Dr. O

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