The FDA said that it has extended expiration dates on some EpiPen and generic versions, all manufactured by Pfizer, by 4 months.
The FDA said Tuesday that it is extending the expiration dates on some EpiPen products in an effort to mitigate shortages of the life-saving medication.1
Specific lots of 0.3 mg EpiPen products and its authorized generics, all manufactured by Pfizer’s Meridian Medical Technologies, are being recommended for use 4 months beyond the labeled expiration dates.1-3 The extension does not include EpiPen Jr products.
The change to recommend use beyond the approved 20-month shelf life is based on stability data provided by Mylan, which markets EpiPen products, and Pfizer, and was reviewed by the federal agency, according to the FDA.1,2
EpiPens and Pfizer’s generic versions, should continue to be stored as labeled, agency officials said.1,2
The FDA is not suggesting relabeling the affected batches of epinephrine products, which are labeled with expiration dates of April to December 2018.
However, the agency said that these products are subject to replacement and are to be properly disposed during the extension period in the event that newer epinephrine auto injectors become available.2
Agency officials are doing everything they can to help reduce shortages of epinephrine products, which many children with allergies take to school, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.1
“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,” she said.1
“We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring. We’re hopeful this action will ensure patients have access to this important medication, and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply," Woodcock said.
The beginning of the school year is historically accompanied by increased product demand.1 However, the FDA also extended expiration dates on some epinephrine auto injector products in the spring.2
Although EpiPen and similar products are available, multiple factors, including regional supply disruptions and manufacturer issues, have contributed to limited availability in certain areas in the United States.1
The FDA said that it is working closely with Mylan on EpiPen production and supply and also has been in contact with the other manufacturers of epinephrine auto-injectors, including Adrenaclick and Auvi-Q, regarding their supply.
In statements, Pfizer officials said that the company recognizes the importance of the medication to people who rely on it and acknowledged manufacturing constraints affecting supply.3,4
In a recorded statement, Freda Lewis-Hall, MD, DFAPA, chief medical officer for Pfizer, said that the company is working “around the clock” to manufacture the product and work on getting it back to full supply.
“Pfizer is working tirelessly to increase production and expedite shipments as rapidly as possible,” she said.4 “Currently, supply of EpiPen in the United States varies from pharmacy to pharmacy, and we cannot guarantee that product will be available at all pharmacies.”
In addition to extending expiration dates, the FDA approved last week its first generic version of EpiPen and EpiPen Jr in an effort to address epinephrine availability and affordability for patients and their families.5 Teva Pharmaceuticals' generic product offers 0.3-mg and 0.15=mg strengths versions of Mylan’s well-known epinephrine auto injector and is indicated for adults and pediatric patients who weigh more than 33 pounds.5
Patients who are experiencing difficulty accessing epinephrine products are being encouraged by Pfizer to call its customer relations team at 800-796-9526 for assistance in locating the medication at pharmacies.3