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FDA Approves Auvi-Q Voice Activated Epinephrine Injector

epinephrine, food and drug administration, fda, sanofi, food allergies

Injectable epinephrine can save lives, but unfortunately, too many people who need the shot in the case of an emergency do not receive it because they – or those around them – are not sure how to use the device. Sanofi US has introduced a new injector which is the first-ever such device that is equipped with audio and visual tools meant to guide patients and their caregivers through the process. Auvi-Q has now been approved by the FDA, announced the company today in a press release.

When a severe, life-threatening allergic reaction occurs, epinephrine should be administered immediately and patients should seek immediate medical attention. Unfortunately, a study by the National Institutes of Health finds that in up to as many as 70% of cases, an epinephrine injection was not given. One of the most commonly given reasons for not providing the treatment included fear or anxiety by the parent or caregiver to administer the required dose.

Auvi-Q is available in two different dosages of epinephrine – 0.3 mg for patients who weigh 66 pounds or more and 0.15 for those between 33 and 66 pounds. The drug has not been studied in patients weighing less than 33 pounds. The epinephrine included in Auvi-Q is bioequivalent to the more commonly recognized product – EpiPen (Dey Pharma LP). Each pack contains two devices with active drug and plus a non-active training device.

During a life-threatening allergic reaction, Auvi-Q talks the user through each step of the injection process. If the person needs more time, it repeats the step-by-step instructions. The device also comes with written instructions printed on the side. In addition, there are audible and visual cues, including a five-second injection countdown and an alert light to signal when the injection is complete.

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Auvi-Q is about the size and shape of a credit card, the thickness of a cell phone and fits comfortably in a pocket or small purse. The device has an automatic retractable needle mechanism to prevent accidental needle sticks. Being compact and easy to carry should remove one obstacle that could be a reason why as many as two-thirds of patients do not carry their epinephrine injector device.

The Centers for Disease Control and Prevention note that food allergies among children are on the rise with almost 18% of kids having at least one. Food allergies are the most commonly-identified trigger and accounts for 30% of all anaphylaxis fatalities. Other reaction triggers include insect bites and medications.

Another problem with failure to give epinephrine during an emergency is failure to recognize the symptoms of anaphylaxis. The symptoms do vary from person to person and from one episode to the next. The most common signs include hives/itching, facial or tongue swelling which causes difficulty to breath or swallow and nausea and vomiting. These symptoms begin within seconds, minutes, or hours after exposure to the allergen. Without treatment, anaphylaxis can result in death.

“As a company committed to patient-centered care, our focus is on creating innovative solutions that make a difference in the lives of people,” said Anne Whitaker, President, North America Pharmaceuticals, Sanofi. “Auvi-Q delivers on this by offering a state-of-the-art epinephrine auto-injector device that addresses the needs of patients at risk for life-threatening allergic reactions and their caregivers.”

Sanofi US