Devour meals health11/11/2023 Rather than worrying about such issues like fat, cholesterol which may develop due to unhealthy snacking, it is better to go in for healthier options that are available. However, it is the choice of the refreshments that decides the harm or benefit and the consequences that may arise. Needles can be particularly difficult.Who would not like munching on snacks at the evening time or at a time when a slight urge to fill up arises? Having snacks at that time is not bad. Imagine what it would be like for someone without medical training. “I’d rather just give them something like Neffy and just shoot it in their nose. And I’m trying to calculate the weight of the patient to see how much to give them, and I’m like, ‘oh, my God, it’s too much,’ ” she said. “I’m standing there with someone who cannot breathe. She went to the medical kit that every plane has inside was a vial of epinephrine and a syringe. Poblete, a nurse, said she was on a plane once when someone had a severe allergic reaction. She said a nasal spray would be a lot easier to carry, and a needle-free option may be less daunting for bystanders to use if someone near them is having a bad allergic reaction. The CEO of the nonprofit group Food Allergy Research & Education (FARE), Sung Poblete, had also hoped there would be another option for people with severe allergies. Popular OTC medicines for colds and allergies don’t work, FDA panel says In this 2006 photo, Sudafed PE nasal decongestant is displayed on a shelf at a Walgreens store in Chicago, Illinois. Her association supports the scientific process for drug development but was disappointed with the FDA decision. “Fear of epinephrine and needle phobia are significant reasons why people are hesitant or delay treatment for a condition that requires immediate action.”Įpinephrine has a long safety record, Carver said. “A nasal spray would give people managing severe allergic reactions (anaphylaxis) more options,” Melanie Carver, chief mission officer of the Asthma and Allergy Foundation of America, said in an email. About 42% instead used an antihistamine, which cannot reverse life-threatening symptoms like epinephrine can. Of the parents who were surveyed, 90% said their child had had a severe allergic reaction, but nearly 3 out of 4 of those parents said their child did not receive epinephrine. But hesitation can equal death.Ī survey conducted by the the Asthma and Allergy Foundation of America found that only 19% of adult patients felt “very confident” using an autoinjector. Although autoinjectors have made shots easier, even people who’ve had practice can hesitate to use them, often because they’re afraid of the needle or because they’re just not comfortable with the technology. Studies have showed that although 3.3 million people have a prescription for a prefilled epinephrine autoinjector, only half consistently carry it with them.Įpinephrine has always come in the form of an injection. About 40 million people in the US experience extreme allergic reactions, often to things like foods, venom, insect stings and medicines. If approved, Neffy would be the first needle-free nasal spray epinephrine treatment for people with severe allergic reactions. “We stand by the totality of the neffy data package generated in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value neffy can provide for patients, families and caregivers living daily with severe allergic reactions.” “We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote,” Richard Lowenthal, co-founder, president and CEO of ARS Pharmaceuticals, said in the news release. In these cases, the company does not have to do an entire resubmission.ĪRS said the FDA requested an assessment of how repeat doses of the nasal spray would do, compared with the injection form of epinephrine. Typically, such a letter will list the deficiencies in a company’s submission and give recommendations as to what actions are needed to get FDA approval. On Tuesday - the day by which an FDA decision was due - the agency issued a Complete Response Letter, which it usually sends when it has questions about data submitted by a company seeking regulatory approval of a product. In May, an independent advisory committee to the FDA recommended that the agency approve the drug, called Neffy. Kids with allergies at risk of developing more of them, study confirms Boy sneezes due to allergies Kontrec/E+/Getty Images/FILE
0 Comments
Leave a Reply.AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |