There is really big news for anyone who carries EpiPens, or spends time with someone who carries an EpiPen or EpiPen Jr.
Mylan reached out to me as a blogger via email to help get the word out. For those of you who like to double and triple-check your sources, you can also find this information on the FDA website and FARE just published an update as well: Updates to Instructions for Epinephrine Auto Injectors.
WHAT ARE THE NEW PATIENT INSTRUCTIONS?
The EpiPen device has NOT changed, but the instructions on how to use EpiPens have changed. I’ve highlighted changes in the image here (quick and easy way to see what’s new). Below are more details provided by Mylan (the pharma company which markets and distributes the EpiPen):
1. Hold patient’s leg and limit movement during administration
Lacerations, bent needles and embedded needles have been reported when epinephrine has been injected into the thigh of young children who are uncooperative and kick or move during an injection. In order to minimize the risk of injection-related injury when administering the epinephrine injection to young children, caregivers are advised to hold the child’s leg firmly in place and limit movement prior to and during injection.
2. Injection hold time reduced from 10 seconds to 3 seconds
After administration, EpiPen® Auto-Injector should be held firmly in place for 3 seconds prior to removal.
3. Patients should seek medical care if they develop signs or symptoms of infection at the injection site
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site. While cleansing with alcohol may reduce the presence of bacteria on the skin, it does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject into the buttock. Patients should seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.
WHY DID THE INSTRUCTIONS CHANGE?
Mylan said in an email to me: “These updates are intended to help patients and caregivers continue to use this medication appropriately in the event of anaphylaxis, a life-threatening allergic reaction.”
But here’s my take on it. For more than 2 years now, I’ve been following conversations in the allergy community about the exact issues Mylan is addressing through these changes. Awful stories and pictures from leg lacerations caused by EpiPen needles. Questions of if you really need to hold the EpiPen in place for 10 full seconds (which increases the chance of someone jerking their leg and getting hurt).
The one time I gave my daughter an EpiPen Jr, I had trouble holding it in place because of the spring inside and I only held it a couple of seconds. It turned out the medicine was still ejected, because I could see her symptoms reversing before my very eyes. I knew from that experience that the full 10 seconds wasn’t needed.
Then I came across the research of Julie Brown, MD, a pediatric emergency physician at Seattle Children’s Hospital. I saw some of her YouTube videos where she demonstrates using the EpiPen in a way that you can see the medication coming out. Check out that post here: See how EpiPen needles work. And then I realized she’s been researching a lot of interesting things with EpiPens and the (now off the market) Auvi-Q, such as sensitivity to temperature and different ways to hold children to give the EpiPen safely. Look at Dr. Brown’s Pinterest board for a lot of this interesting information. I also had the opportunity to hear Dr. Brown present the latest research at the Food Allergy Blogger Conference last fall and I was beyond impressed and learned a lot. I think it’s safe to say that the work Dr. Brown has been doing to research and help report these patient complications has made a difference and affected change. Way to go!
HOW WILL THIS IMPACT THE COMMUNITY?
In a conversation earlier today, I asked Dr. Brown how these changes will impact the community. She shared, “I’m so pleased with the changes in FDA labeling for epinephrine auto-injectors. The recommendation for restraint of children is clearly important guidance for parents, and I believe will help prevent further auto-injector associated injuries. The decrease in hold time for EpiPen is well supported by the evidence, and again is likely to decrease injuries. I also believe it will make the administration less painful and less scary for kids. It’s as easy as 1-2-3!”
Patients will be much safer because of these changes. Now it’s time to get the word out!
WHAT DO I NEED TO DO NOW?
If you, or someone in your family, has an EpiPen or EpiPen Jr, please share the new instructions ASAP with everyone who helps watch out for their safety. This includes daycare providers, teachers, school nurse and co-workers. Feel free to share my post, the information from the FDA or the FARE post linked above.
Next, share it with your community. Share on social media. Share with your local allergy groups. Call up your doctor and/or allergist’s office. It will take awhile for Mylan to get this news to everyone and it’s in all of our best interest to update everyone we come can as soon as possible.
You can find more of my food allergy posts, tips & recipes on my Food Allergy page. I’d also love to connect with you on my Marketing Mama facebook page and twitter. This post, and all posts on this blog, are written from my experiences as a parent of a child with food allergies. I am not a medical expert and encourage you to consult with a doctor on your personal medical situation.
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