Some EpiPens can be used four months past their expiration date, the Food and Drug Administration (FDA) said Tuesday.
The move is intended to address intermittent supply shortages of the epinephrine auto-injectors, which have persisted for several months.
“Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., said in a news release.
The FDA reviewed EpiPen stability data and extended the expiration date of certain lots of 0.3 milligram auto-injectors. It is advising patients to store them properly. The full list is at https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm. Patients and pharmacies trying to locate available EpiPens also can call distributor Mylan at 800-796-9526.
Pediatricians looking for alternatives can prescribe Auvi-Q auto-injectors, which are shipped to patients.
Another option, a generic version of Adrenaclick from Impax Laboratories, has experienced manufacturing delays in recent months and issued a warning in June about the possibility of particles in the solution of some auto-injectors.
Last week, the FDA granted approval to Teva Pharmaceutical Industries Ltd. to market new generic versions of EpiPen and EpiPen Jr., but the company has not announced a date when they will be available.
