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FDA OKs Epinephrine Auto-Injector for Small Children

FDA OKs Epinephrine Auto-Injector for Small Children

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The FDA has approved the first epinephrine auto-injector specifically designed for infants and small children weighing 16.5-33 pounds, kaléo, the device’s manufacturer, announced Monday.

The AUVI-Q 0.1 mg device is “specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds (7.5 to 15 kilograms) who are at risk for or have a history of serious allergic reactions,” the company said in a press release. The device has a shorter needle and lower dose of epinephrine compared with injectors currently on the market. It also includes electronic voice instruction and visual cues to help with administration.

“Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine auto-injector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency,” said Vivian Hernandez-Trujillo, MD, a pediatric allergist at Nicklaus Children’s Hospital in Miami, in the release. “Having an epinephrine auto-injector with a needle length and dose specifically designed for infants and small children should help alleviate concerns around hitting the bone or injecting too much epinephrine.”

More children are getting treated for anaphylaxis, the company noted, citing a study that found a 129.8% increase in emergency department visits for the condition by children age 4 and younger between 2005 and 2014.

“The approval of an epinephrine auto-injector specifically designed for infants and small children is timely, especially given the recent changes to guidelines recommending that certain high-risk infants, as young as 4 to 6 months old, be introduced to peanut-containing foods,” said Eleanor Garrow-Holding, president and CEO of the Food Allergy & Anaphylaxis Connection Team, in the press release.

“We are pleased that the pediatric allergy healthcare community and parents of infants and small children with life-threatening allergies will have the ability to obtain an FDA-approved epinephrine auto-injector in the event of an allergic emergency.”

The device is expected to become available to patients in the first half of 2018, according to the company, which is based in Richmond, Virginia.


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