Currently viewing the tag: "auto-injector"

LoveAuviQIf you haven’t seen it yet on social media, there’s no doubt you will: A petition to the Chief Medical Officer of Sanofi urging him to quickly bring the Auvi-Q® epinephrine auto-injector back to market.  Here is the text from the petition:

As people with life-threatening allergies or parents of allergic children, we appreciate that the Auvi-Q is an awesome innovation, and we want you to know we are not giving up on you. We hope you are not giving up on us! Setbacks are a part of innovation, and we trust you will work quickly and diligently to fix the problem. Please bring the Auvi-Q back on the market as soon as possible, and we will be there to fill our prescriptions. Thank you!

The petition is in response to a recall by Sanofi of all its Auvi-Q and Allerject® branded auto-injectors from the US and Canadian markets due to numerous reports the device potentially delivered less epinephrine than advertised or none at all. [See Chronology of the Perfect Storm That Hit the Food Allergy Community.]

We understand the draw of the Auvi-Q given its small form-factor and innovative verbal instructions that guide the user through the administration process. It’s a terrific option for children and adults alike – if only it worked as advertised.

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auvi-qSanofi has established a process to refund out-of-pocket expenses resulting from their recall of Auvi-Q epinephrine auto-injectors. Please follow these instructions reprinted from their website to ensure you receive timely and complete compensation:

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auvi-qAdditional information has been published clarifying the reason behind Sanofi’s recall of all Auvi–Q® and Allerject® epinephrine auto-injectors in the US and Canada.

While in their original press release, Sanofi stated the reason for the recall was “potential inaccurate dosage delivery”,  an article published Thursday evening by Dow Jone Business News quotes a spokeswoman for Sanofi stating the Auvi-Q devices in question “potentially delivered too little epinephrine or none at all.”

The company, which announced the recall while presenting their third-quarter results, expects the related costs to the firm will be $150 million in net income.

In regard to the availability of alternative auto-injectors, the article quotes a spokesman for CVS saying: “We don’t anticipate any widespread shortages or problems meeting demand”, and a Walgreens spokesman saying that about 95% of its stores have EpiPens in stock and are “in good position to meet any increased consumer demand.”

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allerject-recallFollowing Sanofi US’s recall of all Auvi-Q auto-injectors sold in the US, Sanofi Canada has issued a recall of all Allerject auto-injectors sold in Canada. Allerject and Auvi-Q are Sanofi’s brand names for the same product sold in the US and Canada respectively.

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Sanofi's Auvi-Q Epinephrine Auto-InjectorSanofi US has issued a voluntary recall of all Auvi-Q epinephrine auto-injectors in the US, including both the 0.15mg and 0.3mg doses. They have been found to potentially deliver the wrong dosage.

the firm has received 26 reports of suspected device malfunctions in the US and Canada as of October 26, though none of these malfunctions have been confirmed by the company and no fatalities have been reported to date.

We urge you to read the Sanofi press release and take immediate action to replace all Auvi-Q devices with other alternatives until the firm has resolved the issue.

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kids-walking-into-schoolWhile parents of children diagnosed with food allergies battle to keep their kids safe, a new study shows that it is not only their children that are at risk for developing life-threatening anaphylaxis at school.

The study, to be presented at the American Academy of Pediatrics (AAP) National Conference & Exhibition in Washington DC this week, looked at schools that participated in the EPIPENS4SCHOOLS program during the 2013-14 school year. The program, sponsored by Mylan Specialty, provides stock epinephrine auto-injectors to 59,000 public and private, elementary, middle and high schools across the United States for use during anaphylactic emergencies.

Among the 6,019 schools responding to the survey, 919 anaphylactic events were reported with 22% of the cases occurring in  individuals with no prior history of allergy. These children would not have had access to their own prescribed auto-injector.

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NJ State HouseLegislation that would provide for stock epinephrine in places of public accommodation has cleared committees and is now under consideration by the New Jersey Senate and General Assembly.

Entitled the Epinephrine Access and Emergency Treatment Act, the bill (designated S-2884 and A-4094) would allow individuals who have completed an approved training course to maintain and administer epinephrine auto-injectors for emergency use, and employers of those individuals to obtain stock epinephrine for use by them. The legislation also provides the necessary “Good Samaritan” provisions to shield all involved from liability when epinephrine is administered in good faith during an anaphylactic emergency.

Anaphylaxis is a serious, sometimes life-threatening allergic reaction to a food, medication or insect sting. Epinephrine is the only approved treatment for anaphylaxis and should be administered as soon as anaphylaxis is suspected.

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epipenEpinephrine is the only effective treatment for anaphylaxis – the life-threatening reaction that may occur as the result of a severe allergy – and the means for carrying and administering epinephrine is the auto-injector. US News & World Report recently published an article bringing a long-simmering debate to the foreground: are the needles used in current auto-injectors long enough to deliver epinephrine effectively in people who are obese?

There are two versions of epinephrine auto-injector approved for use in the US: a half-dose for young children weighing less than 66 pounds, and a full-dose of 0.30 mg for adults and children weighing more. Few people realize that the needle lengths for the two doses also vary: for example, for the EpiPen Jr the needle length is 1/2″, for EpiPen the length is 5/8″. That needle length is calculated to deliver epinephrine through clothing, skin and subcutaneous fat to the thigh muscle.

In a study published a year ago in Allergy, Asthma & Clinical Immunology, researchers measured the muscle depth of 100 participants with severe food allergies and found that 19%, all women, had a depth that was greater than the needle length.

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Yesterday, National Public Radio’s All Things Considered aired a segment entitled “How Smart Marketing Transformed EpiPen Into A Billion-Dollar Product”. The 5-minute interview by host Robert Siegel of Cynthia Koons, a reporter for Bloomberg Business who published a report on the topic last week, is well worth your time especially if your family relies on epinephrine to stay safe. You can listen to it here:

Koons discusses how Mylan, the pharmaceutical company behind EpiPen, acquired the product in 2007 from a German firm and turned it into the household name we know today. She also discusses the cost of the product as well as Mylan’s aggressive campaign to have stock epinephrine located at schools and other places of public accommodation.

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By now you may have read of yet another food allergy-related tragedy, the passing of Simon Katz, a 16-year old student of Chatfield High School in Littleton, Colorado. He was rushed to the hospital on Monday after inadvertently taking a bite of a s’more made with peanut butter at a school homecoming celebration after suffering anaphylactic symptoms.  He was pronounced dead at the hospital despite multiple shots of epinephrine and CPR administered by his father on the way.

This was the second report of a teen death due to anaphylaxis in a week, yet another horrific nightmare to befall a member of the allergic community. Our heartfelt and deepest sympathies are with the Katz family.

As we generally do when anaphylaxis-related tragedies appear in the news, we seek out the only good that can come from such reports, namely learning from the experience to prevent such occurrences in the future. Here are a number of extenuating circumstances that were reported in the media:

  • Simon did not have his epinephrine auto-injectors on-hand
    He had a habit of keeping his auto-injectors in his car, but he caught a ride to school that day with his friends. By the time his friends were able to transport him home, he was vomiting and suffering severe symptoms.

    Early administration of epinephrine is paramount to the successful treatment of anaphylaxis and it should be administered as soon as symptoms present themselves, or immediately after inadvertently ingesting an allergen that has caused anaphylaxis in the past as directed by your physician. On the best day, Simon’s epinephrine was waiting in the parking lot and administration would have been delayed; on this, the worst day, his epinephrine was not available, possibly costing him his life.

  • He was taken home instead of straight to the emergency department of the closest hospital
    Simon was in the throes of a severe anaphylactic response to a known allergen, a medical emergency by any definition. While we sympathize with his friends who thought they were doing the right thing, they should have been educated to seek immediate medical attention for him.
  • He consumed an unwrapped food that did not come from home
    Simon’s father, David Katz, told reporters that s’mores were one of Simon’s favorite treats, but he mistakenly ate one that was made with Reese’s Peanut Butter Cups. It is presumed the peanut butter was the trigger of his allergic response.

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