WASHINGTON - Nearly half a million Auvi-Q epinephrine injectors, which are used to treat severe, life-threatening allergic reactions, are being recalled. The problem is the devices are not delivering an accurate dose of the lifesaving medication.
Twenty-six reports of malfunctioning devices have triggered this nationwide emergency recall.
It comes just two days before Halloween, which is already an extremely challenging time for children with life-threatening allergies to foods like nuts.
This recall is creating a whole new scare for their parents who have been told this device may not do its job and is leaving many scrambling to get their hands on other alternatives like an EpiPen, just in time for their children to safely go trick-or-treating.
Junga Kim always needs a lot of epinephrine injectors on hand. One of her daughters has anaphylactic allergies to nuts while her other child is severely allergic to nuts and eggs, and they need devices at home, school and onsite for after-school activities.
But every box she has for them and their father, who is allergic to bee stings, is now part of the nationwide emergency recall of Auvi-Q.
“My kids are not covered should they have a reaction,” said Kim. “It's tremendously scary. You hear too many stories of young children dying because they didn’t get the EpiPen in time. This is life and death for us.”
Sanofi, the maker of Auvi-Q products, says it is recalling nearly half a million epinephrine injectors amid concerns they aren't dispensing the intended dose of the lifesaving medication to patients at risk for extreme and deadly reactions.
“Halloween is one of the times when we have some of the biggest problems with accidental exposures, particularly peanuts and tree nuts,” said Dr. Jim Mattey.
Not surprisingly, the phone has been ringing off the hook at The Pediatric Care Center in Bethesda with questions for allergists like Dr. Mattey, who primarily treats children.
“It's very significant because all our patients who are severely food allergic and need to have their adrenaline available really do need to have their adrenaline available,” said Dr. Mattey.
He has written 25 replacement prescriptions for patients by mid-morning and was dosing out a lot of advice too.
“My personal recommendation to the patient is do not throw your Auvi-Q away until you have a replacement,” said Dr. Mattey. “We're not worried about the quality of medication. It's more of a question of the adequacy of the dose if you needed to use it. My suggestion would be that it would be better to use the Auvi-Q if you have nothing else and you needed it."
Many are finding the Auvi-Q help line busy, but the company's website suggests getting a replacement as soon as possible. Kim headed to her local drugstore Thursday afternoon to do just that.
“They didn’t have enough to fill my other prescriptions so I need to come back tomorrow to get three more pairs,” she said.
They only had half the boxes she needs to replace, but with these in hand, she said she does feel more comfortable.
“Much better,” said Kim. “More prepared and my kids can eat.”
The maker of Auvi-Q says it will ultimately reimburse patients for new epinephrine auto injectors.
But a lot of allergy parents are scrambling to figure out exactly what they need to do in the next day or two to make sure they get a properly working device before Halloween.
Parents of college students who use them are also trying to figure out how to best get replacements to their children who may be in school far away.
Here is a list to walk you through the steps you need to take in the next 48 hours before Halloween.
Auvi-Q Recall Tips -- How to prepare for a safe Halloween over next 48 hours
All Auvi-Qs are part of the nationwide recall. The recall only applies to the Auvi-Q brand of epinephrine injector. It does not apply to Epi-Pen and Epi-Pen Jr. or Adrenaclick, the other alternative brands on the market.
- Keep your Auvi-Qs until you have another form of epinephrine autoinjector. But per Sanofi (the makers of Auvi-Q), only use your recalled devices if there is NO OTHER EPINEPHRINE AUTOINJECTOR available. The medication in the recalled Auvi-Qs is safe but the devices are not delivering the proper doses.
- If you or someone you are with experiences a severe allergic reaction, call 911 immediately.
- Epinephrine injectors are only available with a prescription. So contact your doctor or your child’s doctor to get a new prescription and get it filled as quickly as possible.
- The two competing brands offer resources including a "$0 Co-Pay Offer" for eligible patients and patient assistance programs for qualified individuals. Patients can download the co-pay card and find out more at epipen.com or adrenaclick.com.
- Call Auvi-Q to report your defective device and get information on how to return it and get reimbursed. (auvi-q.com) The company says due to high call volume, the lines are sometimes down or busy. They are asking people to be patient and call back.
While you are working to get a replacement:
- If you have an EpiPen or Adrenaclick elsewhere (like school, daycare, a grandparent's house), consider borrowing it back for the weekend to cover the often stressful days surrounding Halloween.
As with every Halloween, talk to your children who have food allergies and set common sense ground rules about candy collection and consumption:
- Do not collect candy you know to be unsafe.
- Teach children to ask if candy being offered has nuts or their particular allergy in it before they reach in a bowl.
- Encourage children to hold their bag out while trick or treating and ask others to drop candy in for them.
- Remind children not to eat candy until you they get home and an adult reviews the ingredients.
- Have safe candy for your child in your pocket while trick or treating and at home to swap out for what they’ve collected.
- Be vigilant about reading labels, even on products you think you are familiar with to avoid an accidental ingestion of a problem food.
- Look out for those fantastic teal pumpkins, which indicate that a house is taking part in the Teal Pumpkin Project (www.foodallergy.org/teal-pumpkin-project) offering non-food treats -- safe for everyone with dietary restrictions!