In these cases, your doctor may want to change the dose, or other precautions may be necessary. Drug InteractionsĪlthough certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fluticasone nasal spray. GeriatricĪppropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone nasal spray in the elderly. Safety and efficacy have not been established. However, safety and efficacy of Veramyst® nasal spray have not been established in children younger than 2 years of age, and fluticasone propionate nasal spray in children younger than 4 years of age.Īppropriate studies have not been performed on the relationship of age to the effects of Xhance® nasal spray in the pediatric population. The company's research included a survey showing that people would be likely to use the spray 18 minutes earlier than an injectable medication, and as many as 35 percent more people would carry it with them.Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluticasone nasal spray in children. The drug is designed to work for patients who weight at least about 66 lb. The company has said it could start selling the spray in late 2023. The FDA is expected to make its decision on whether to approve Neffy by the middle of this year. As a result, it is not entirely clear whether the nasal spray will work as well as injectable epinephrine. That means the FDA does not have a lot of data it can use to compare Neffy's effectiveness in saving patients who are having a severe allergic reaction. It was never put through the same approval process as drugs are now because it was on the market before the FDA existed, CBS News reported. "With Neffy, blood pressure and heart rate are comparable to EpiPen with a single dose - and with a second dose of Neffy, increases in systolic blood pressure were statistically higher, even better than revealed in the available data from EpiPen, which is crucial for patients requiring a second dose for a severe allergic reaction."Įpinephrine has been used since 1901 via injection. "The effects of epinephrine on blood pressure and heart rate are surrogates for efficacy and are important in determining if someone is responding to treatment," Carlos Camargo, M.D., a professor of emergency medicine at Harvard Medical School in Boston, said in the company's news release. It showed the results for Neffy were neither substantially higher or lower than injectable epinephrine. Instead of large clinical trials, the drug company compared its product to already approved injectable epinephrine products, such as the EpiPen. Neffy delivers a 2-mg dose of epinephrine. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions.Īlthough most of the Pulmonary- Allergy Drugs Advisory Committee members supported the spray for adults (16:6) and children (17:5), key questions linger about whether more data are needed from its maker, ARS Pharmaceuticals, CBS News reported.īut Richard Lowenthal, cofounder, president, and CEO at ARS, said in a company statement following the vote, "We believe our clinical data from more than 600 individuals demonstrate Neffy's absorption-enhancing nasal spray technology is comparable to injectable products in delivering potentially lifesaving epinephrine, but with unique advantages of being small, needle-free, and conveniently sized." FDA Panel Recommends Approval of First Nasal Spray to Combat Severe Allergic Reactionsīy Physician’s Briefing Staff HealthDay ReporterįRIDAY, - Outside advisers for the U.S.
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