EPI Autoinjector Deadly Warning

We suspect most of your readers are familiar with the EPIPEN.  Its black needle tip and grey safety cap has been a standard for almost 40 years. In the fall of 2010, the EPIPEN colors were changed: the black needle end became orange and the grey safety cap became blue.  Other changes were made to the EPIPEN autoinjector that might not be readily apparent to all providers or users, especially in the excitement of a life-threatening anaphylactic reaction. Photo for clarity may be seen at Wildernessmedicine.com on our blog.  One of them is not epinephrine, but might find its way into your hands or your patients, and would allow a patient in anaphylaxis to die. There is no warning that it is not epinephrine despite its nearly identical appearance to traditional epinephrine autoinjectors. The drug name administered by the non-epinephrine autoinjector is Alsuma, an anti-migraine medication. The new EPIPEN is oval, same length and colors. Studies have shown 9 year old EPIPENs still have 63% efficacy (FR Estelle Simons J Allergy Clin Immunol. 2000 May;105(5):1025-30.) and many consumers and physicians are aware of this, so it is likely we will have this problem for several more years. We urge all Alsuma autoinjectors be labeled NOT EPI in red and black letters on the white container. There are other EPI autoinjectors in a white container. This warning and request for relabeling is being sent to the FDA who we hope will require Alsuma to apply strong adhesive labels to device and case saying NOT EPI until both can be redesigned to more clearly differentiate this product from epinephrine autoinjectors.

Carl Weil, NREMT-I/C, FAWM
Director, Wilderness Medicine Outfitters
Education Director, Anaphylaxiseducators.com
Elizabeth, Colorado
David Fitzpatrick, MD, FAWM FAAFP
Anaphylactic specialist and patient
Goosecreek, South Carolina
Seth C. Hawkins, MD, FACEP, FAAEM, FAWM
Morganton, NC