EpiPen and Adrenaclick Epinephrine Injection Shortage
May 9, 2018 – The U.S. FDA has added the EpiPen® (epinephrine auto-injector, 0.3mg) and EpiPen Jr® (epinephrine auto-injector, 0.15mg), manufactured by Mylan Pharmaceuticals, to its list of drugs in short supply. In addition, both products’ authorized generics have been placed on the list.
Mylan has stated that the shortage is due to manufacturing delays that may cause brief, unexpected supply disruptions in various parts of the country. The company is offering assistance in locating a pharmacy with their products in stock through Mylan Customer Relations at 800-796-9526.
An alternative to Mylan products, Adrenaclick® (epinephrine injector, auto-injector), made by Impax Laboratories, is also currently subject to shortages in its 0.3mg and 0.15mg strengths.
Kaleo’s Auvi-Q® (epinephrine injection, USP) is available in all three strengths, 0.3mg, 0.15 and 0.1mg, and not currently subject to shortage. Patients who wish to change their prescription from their usual epinephrine injection should speak to their doctor, and be sure to consult with their prescriber or pharmacist about the proper way to use the new device.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.