Allergy sufferers generally rejoice when they discover that a prescription allergy medication they have been taking has been approved for sale over the counter.
If, for example, Allegra has always helped with your spring allergies, over-the-counter sales mean one less trip to the doctor’s office, which represents a savings of time and money. In recent years, several formerly prescription-only allergy drugs have made the transition to over-the-counter sales, including Claritin, Zyrtec, and Allegra. And if the US Food and Drug Administration follows the recommendations of a recent advisory panel, Nasacort, a nasal spray used to treat allergies in adults and children, will be available over the counter as well. Nasacort is made by French drug manufacturer Sanofi.
Nasacort Was Approved by FDA Advisory Panel for OTC Sales
At the end of July, the FDA nonprescription drug advisory panel recommended by a vote of 10 to 6 (with two members abstaining) that Nasacort be approved as a nonprescription drug. The FDA is not required to go along with what the panel recommends, but in general, they do, and there is no reason to believe they will go against the advisory panel vote in this case. If Nasacort does become a nonprescription drug, it will mark the first time that a corticosteroid spray will be available over the counter for treating allergies. Other OTC allergy meds include nasal decongestants or antihistamines.
Why Nasacort Is Different than Other OTC Allergy Medications
Nasacort is used to treat allergies that cause allergic rhinitis, or swelling inside the nose, like allergies caused by dust, animal dander, and pollen. Allergic rhinitis affects approximately 60 million Americans and is characterized by symptoms like watery, itchy eyes, sneezing, and runny nose. As a prescription drug, Nasacort is used in patients aged 2 and older. The vote in favor of OTC sales indicates that those in favor believe that the risk-to-benefit profile of Nasacort makes it appropriate for sales without a prescription.
Reservations on OTC Status by Some Panel Members
Some members of the advisory panel explained their votes against selling Nasacort over the counter by citing concerns over the possible negative impact on growth in children with long-term use of steroid nasal spray. These members suggested that OTC sales of Nasacort be accompanied by labeling stating that the OTC drug should only be used by adults, and children should only take it if prescribed by a physician. One panel member who voted against OTC approval was Stanford University associate professor of pediatrics Lee Sanders, who said he was uncomfortable recommending the product for OTC use in children under age 12.
According to the FDA, one study evaluating children age 3 to 9 reported a decrease of about one-half centimeter in growth after one year among children using Nasacort compared with a control group using a placebo. Medical groups like the American Academy of Pediatrics told the FDA advisory panel that they did not support OTC sales of steroid nasal sprays for allergies due to worries about correct monitoring of side effects outside a health care setting.
In 2012, steroid nasal sprays for allergies accounted for about $2 billion in sales in the US. Nasacort accounted for around $94 million in sales. Other similar drugs include Nasonex, made by Merck, and Veramyst and Flonase, made by GlaxoSmithKline. These other manufacturers are not saying whether or not they are considering trying to transition their products to OTC sales. It is not yet clear exactly what labeling concerning use of Nasacort in children under 12 will be required in packaging if the drug is indeed sold over the counter.
For now, Nasacort is only available via prescription. Thankfully, eDrugstore.com is committed to bringing customers the allergy relief medications like Nasacort that they need for relief of their symptoms. We are committed to the highest standards of customer satisfaction, privacy of customer information, and security of online transactions.
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