Response: Re: Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy

The above letter was referred to the authors of the article in question, who offer the following reply.

To the Editor: I appreciate the interest Enoz has expressed in our publication. We agree that none of the medications we discussed in our article have been listed as Pregnancy Category A. Indeed very few studies have been done in pregnant women for any medication and so we are often left using Pregnancy Category B or even Pregnancy Category C medications when the benefits seem to outweigh any potential risks.

In regard to the use of Nasaleze spray for the treatment of allergic rhinitis during pregnancy, I read your references with interest. The first 2 are by the same author reviewing information for Current Medical Respiratory Opinions.^1,2 The studies were not done in pregnant women. The third reference is an opinion piece and review.³ The fourth reference study does not really seem to be related to treatment of allergic rhinitis but to delivery of nasal glucagon—a phase 1 study to determine whether it can be done in healthy volunteers.⁴ Although interesting, these studies do not provide sufficient information for Nasaleze to be listed as a Pregnancy Category A, B, or even C. In fact it was not clear that this product has been reviewed by the FDA as a drug because it is currently listed as a medical device. It can be exported into the United States according to the Nasaleze websites.

The mechanism of action of Nasaleze is unknown but may be due to the cellulose powder reacting with moisture within the airway to produce a protective barrier over the nasal mucosa, preventing binding of inhaled allergens with receptors.^1–3,5 I could find no study that discussed its use in pregnant women.⁶

I look forward to further developments that provide additional options for the treatment of allergic rhinitis in pregnant women. However, I do think it is important to remember that being “natural” does not automatically mean “safe” because many potent compounds such as digitalis and Coumadin are also “natural.” If the product is inert and has no adverse effects when sprayed into the nose, swallowed, or inhaled, then indeed it may be safe but further study seems warranted.