Are EpiPens malfunctioning? How can I check if mine is safe to use?

Answered by Shivam Patel, PharmD, BSPS, RPh | Posted April 16, 2020

The FDA issued an alert of EpiPen auto-injector errors related to the devices malfunctioning on March 23rd, 2020. Pfizer and Mylan, the drug manufacturer and marketer of EpiPen, announced that patients, caregivers, and providers should be cautious of EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors including the authorized generic versions. In a letter, they outline that these EpiPen devices may not work due to:

  • “Device failure from spontaneous activation caused by using sideways force to remove the blue safety release.
  • Device failure from inadvertent or spontaneous activation due to a raised blue safety release.
  • Difficulty removing the device from the carrier tube.
  • Certain identified use errors.”

Despite these problems, the Epipens have not been recalled (as of April 15th 2020). You can visit the FDA website for the most up-to-date information regarding this EpiPen alert.

Your EpiPen device may very well be fine, but we now know they can malfunction and it could obstruct emergency treatment at the time of need. This is why you must ensure that your EpiPen works correctly ahead of the time of need.

What is Epipen (epinephrine)?

EpiPen (epinephrine) is an expensive medication that is used in the treatment of life-threatening allergic reactions, called anaphylaxis, caused by certain foods, latex, insect bites or stings. It’s important to remember that the first line of defense is to always avoid your allergens to protect yourself from allergic reactions. EpiPens work by tightening blood vessels in your body. This, in turn, relaxes airway muscles, allowing you or your child to continue breathing during the reaction. Epipens come as a prefilled automatic injection device that is administered under the skin. EpiPens can save lives, so it's important to routinely check on expiration and any potential issues with your device.

How can I make sure the EpiPen will work correctly?

Having to ensure your EpiPen is working properly may feel extremely stressful. After all, you already have the stress of constantly making sure to have an Epipen on hand! But, due to these product safety problems, you will need to take extra steps to ensure your or your loved ones’ safety. Let's get into the steps you can take to make sure your life-saving medication works before it comes time for you to use it.

  • Firstly, if you have any questions or need guidance regarding your EpiPen, remember you should always speak with your local pharmacist or provider. They are trained to equip you with knowledge to successfully administer your EpiPen.

  • Always use BOTH hands to remove the blue safety release straight up. It is important to NOT flip the blue safety release off with your thumb, or any other sideways twisting of the device. If you need to administer on a child, first restrain the child, then use BOTH hands to remove the blue safety release straight up.

  • Inspect your EpiPen devices to verify the blue safety release is not raised. If the blue safety release is raised, this device should NOT be used. Speak to your provider to contact Mylan Customer Relations at 1-800-796-9526 to get a replacement at no additional cost.

  • Before your devices have been used, flip open the caps of the carrier tubes. Then tip each carrier tube to check that each auto-injector easily slides out of the tube.

What should I do if I notice a problem with my EpiPen?

If you notice a problem with your EpiPen, contact your local pharmacist or healthcare provider immediately. Let them know what you discovered in detail and they will provide you the best options for replacement. Do not rely on your EpiPen if you suspect a problem with it, and act quickly to make sure it will work correctly at the time of need.

Are there any alternatives to EpiPen or its authorized generic?

An authorized generic is made using the same exact formula, process and manufacturing as the brand name but just the labeling does not have the brand name.

One alternative to EpiPen and its authorized generic is Adrenaclick, manufactured by Impax Laboratories. Adrenaclick is also an epinephrine auto injection device similar to EpiPen. With Adrenaclick and its authorized generic, the patient needs to remove both caps on opposite sides of the auto-injector before administering. With EpiPen and its authorized generic, the patient takes the device out of the carrier tube and removes the blue safety release before administering.

Another epinephrine auto-injection device is called Auvi-Q. This device is unique because it provides voice guidance instructing patients on how to administer the device step-by-step. The Auvi-Q device is smaller than EpiPen and has a needle that retracts after it's administered.

How do I use an EpiPen correctly?

If you or a loved one are prescribed EpiPen, don't wait until an emergency to understand how to use your EpiPen. You can watch this video that describes how to correctly use an EpiPen. Here is a pamphlet with images that also describes how to use an EpiPen.

According to Mylan the manufacturer of Epipen, here is how you can use EpiPen correctly:

“1. Prepare

  • Remove the Auto-Injector from the clear carrier tube.
  • Flip open the yellow cap of your EpiPen® or the green cap of your EpiPen Jr® carrier tube.
  • Tip and slide the auto-injector out of the carrier tube.
  • Hold the auto-injector in your fist with the orange tip pointing downward.
  • Blue to the sky, orange to the thigh®.
  • With your other hand, remove the blue safety release by pulling straight up without bending or twisting it.

2. Administer

  • If you are administering to a young child, hold the leg firmly in place while administering an injection.
  • Place the orange tip against the middle of the outer thigh (upper leg) at a right angle (perpendicular) to the thigh.
  • Swing and push the auto-injector firmly until it “clicks.” The click signals that the injection has started.
  • Hold firmly in place for 3 seconds (count slowly 1, 2, 3).
  • Remove the auto-injector from the thigh. The orange tip will extend
  • to cover the needle. If the needle is still visible, do not attempt to reuse it. Massage the injection area for 10 seconds.

3. Get Emergency Medical Help Right Away

  • You may need further medical attention.
  • If symptoms continue or recur, you may need to use a second EpiPen® or EpiPen Jr® Auto-Injector.”

Still need more information on how to use your EpiPen? Call Mylan at 1-877-446-3679 or visit www.epipen.com anytime.

How much does an EpiPen cost?

Consumers can find significant savings for EpiPen and its alternatives at PharmacyChecker-accredited international pharmacies.

Comparing EpiPen and Alternatives Prices

Drug (generic name) Strength Quantity Average U.S. Retail Pharmacy Price Lowest International Online Pharmacy Price Percentage Savings
EpiPen (epinephrine) 0.3mg two-pack $662.59 $281.23 58%
EpiPen Jr. (epinephrine) 0.15mg two-pack $699.11 $253.74 64%
Generic EpiPen (epinephrine) 0.3mg two-pack $399.09 $192.99 52%
Generic EpiPen Jr. (epinephrine) 0.15mg two-pack $385.78 - -
Auvi-Q (epinephrine) 0.3mg two-pack $5,600.90 - 14%
Adrenaclick (epinephrine) 0.3mg two-pack $463.06 - -
Generic Adrenaclick (epinephrine) 0.3mg two-pack $228.06 - -

Sources: Average U.S. Retail Price calculated based on pricing on GoodRx.com. PharmacyChecker Discount Card Price based on pricing near White Plains, New York (Zip:10605). Lowest PharmacyChecker-accredited International Pharmacy Price based on prices listed on PharmacyChecker.com.

Learn more about EpiPens and affording medication

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