Corticosteroid Nasal Sprays Approved for Over-the-Counter Use

In October 2013, the first intranasal corticosteroid nasal spray became available for over-the-counter (OTC) use after the U.S. Food and Drug Administration (FDA) approved Nasacort AQ (triamcinolone acetonide) for the nonprescription treatment of nasal allergy symptoms.

The decision was met with some controversy, most notably in a response from the American Academy of Otolarnygic Allergy (AAOA), the American Academy of Allergy, Asthma and Immunology (AAAAI), and the American College of Allergy, Asthma and Immunology (ACAAI). These organizations submitted their response to the FDA detailing their objections to making these sprays OTC due to safety concerns.

In their response, the AAAAI and ACAAI described updated studies that supported their earlier recommendations against the OTC use of intranasal corticosteroid nasal sprays published in a position paper in 2006 (Ann Allergy Asthma Immunol. 2006;96:514-525). Highlighted in both the position paper and a 2013 response to the FDA decision was the need for clinician monitoring of these sprays to avoid potential adverse effects, including growth suppression in children and ocular side effects and osteoporosis in some individuals.

Bryan Leatherman, MD, secretary of the AAOA board of directors, says his organization expressed concern over ensuring patients were receiving an accurate diagnosis of their nasal problems, were given good information about appropriate treatment options, and that they were monitored long-term for potential side effects.

Another concern is that some patients may not be knowledgeable in how to use the product. “We know that these [medications] are extremely effective, but only when used the right way, and with the knowledge that they only should be used once a day,” said Alpen Patel, MD, who serves as AAOA socioeconomic chair. Also, he said, “they may not use it long enough and may prematurely give up on it.”

Effect on Treatment of Patients

According to Timothy L. Smith, MD, MPH, professor of otolaryngology/head and neck surgery at Oregon Health and Science University in Portland and

ENTtoday editorial board member, the approval of this first intranasal spray for OTC use has occurred too recently to know how it will affect patients and otolaryngology practice. “I don’t think anyone knows yet how this will play out, but it needs to be actively monitored,” he said, adding that the issue of approving these sorts of drugs for OTC use is on his radar screen but that he doesn’t have any immediate concerns about their use.

Having said that, he did emphasize the need to place the approval in the context of all medical treatments—namely, the risks and benefits of making these sprays OTC must be weighed. “Any time someone is using a topical corticoid steroid, there is a potential for adverse effects to the nasal cavity and, ideally, you have a clinician to oversee that and look for those types of problems,” he said. “On the other hand, there may be some people who don’t have access to these types of medication who now will have access.”

For Thomas B. Casale, MD, executive vice president of AAAAI and professor of internal medicine in the division of allergy and immunology at the University of South Florida’s Morsani College of Medicine in Tampa, the biggest concern with OTC use of these sprays is not the safety of the drugs themselves but the lack of clinician oversight of the disease process the drugs are used to treat.

While saying that the drugs themselves are fairly safe, Dr. Casale emphasized that optimal treatment of allergies requires consultation with a physician. “Trivializing the disease by using over-the-counter medications may result in impaired quality of life and poorer outcomes for patients,” he said. “Consultation with a physician … would help identify things that the patient can do in addition to medications.”

What Time May Tell

Dr. Smith highlighted the fact that more time will need to pass before otolaryngologists and other clinicians know the full extent of how these OTC sprays will affect their practice. “I imagine there is only a very small proportion of patients who are accessing this nasal spray OTC,” he said. “We have not seen the peak of this, not even close. As other comparable sprays start to go OTC, we will see a shift and then may or may not see an increase in adverse effects from these OTC medications because of the lack of clinician oversight.”

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Mary Beth Nierengarten is a freelance medical writer based in Minnesota.