Sep 14, 2018
There is an ongoing shortage of epinephrine auto-injectors causing a crisis for mast cell disease patients attempting to fill their prescriptions.
Our F.A.R.E. (Food Allergy Research & Education) colleagues have recommended the following steps:
- Visit http://healthmart.com/ to find an independent pharmacy.
- Ask your doctor for another brand and get trained on how to use it.
- Don’t toss your expired epinephrine auto-injector- if it’s all you have, use it in an emergency, then call 911 and seek medical treatment.
The FDA has declared this a national shortage; granted approval to Teva’s applications for the first generic version of the EpiPen and EpiPen Jr. and has extended the expiration date on certain lots of EpiPen.
FDA drug shortages: https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
Generic EpiPen approval: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617173.htm
EpiPen expiration date extension: https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm
Recommendations from MYLAN regarding EPIPEN:
Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, continues to experience manufacturing constraints affecting supply. Currently, supplies will vary from pharmacy to pharmacy, and may not always be available.
On Aug. 21, 2018, the U.S. Food and Drug Administration announced to extend the expiration dates of specific lots of EpiPen 0.3 mg Auto-Injectors and its authorized generic version, after review of stability data. Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth quarter of 2018.
This announcement is based on a careful review of product stability data provided by Pfizer. We believe the extension of the expiration date will temporarily address patients’ access to and use of EpiPen 0.3 mg Auto-Injectors, and its authorized generic, particularly during back-to-school season as demand increases.
The affected lots, which have current expiration dates between April 2018 and December 2018, are listed with their new expiration dates on FDA’s website and EpiPen.com/EpiPenSupply. Please visit these sites to determine if your auto-injector has an extended expiration. The extension of the expiration dates does not apply to EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors and its authorized generic version. Patients should continue to adhere to the manufacturer’s expiry date labeled on EpiPen Jr 0.15 mg and Epinephrine Injection, USP Auto-Injector 0.15 mg products.
Mylan and Pfizer place great importance on the consistent availability of EpiPen for everyone who needs it. Pfizer is working tirelessly to increase production and expedite shipments as rapidly as possible. Currently, supplies will vary from pharmacy to pharmacy, and we cannot guarantee that product will be available at all pharmacies.
We understand the challenges this situation continues to pose to patients. Ensuring continuity of the supply of our medicines is paramount.
Mylan, the distributor, is expediting shipments upon receipt from Pfizer and continues to encourage patients who are experiencing difficulty accessing product to call its Customer Relations team at 800-796-9526 for assistance in locating other pharmacies. To further assist patients during this period of limited supply, Mylan recently extended its Customer Relations hours to Monday through Friday, 8 a.m. to 7 p.m. ET and Saturday through Sunday, 11 a.m. to 4 p.m. ET.
|Important Safety Information|
|Use EpiPen (epinephrine injection, USP) 0.3 mg or EpiPen Jr (epinephrine injection, USP) 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. EpiPen or EpiPen Jr should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.
Rarely, patients who have used EpiPen or EpiPen Jr may develop an infection at the injection site within a few days. Some of these infections can be serious. Call your healthcare professional right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.
Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use EpiPen or EpiPen Jr.
Common side effects include fast, irregular or “pounding” heartbeat, sweating, nausea or vomiting, breathing problems, paleness, dizziness, weakness, shakiness, headache, feelings of over excitement, nervousness or anxiety. These side effects usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.
|EpiPen and EpiPen Jr Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.
For additional information, please contact us at 800-395-3376.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
EpiPen, EpiPen Jr, EpiPen 2-Pak, EpiPen Jr 2-Pak, and the Mylan logo are registered trademarks of Mylan Inc. All other trademarks and service marks are the property of their respective owners.
© 2018 Mylan Specialty L.P. All rights reserved. EPI-2018-0235