FDA anticipates ‘short-term’ EpiPen shortage

The US Food and Drug Administration added EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors as well as generic versions of these products to its drug shortages list Wednesday. The agency’s website cites “manufacturing delays” as the “shortage reason” but notes that these products are still currently available.

EpiPen and EpiPen Jr. are devices made to deliver the lifesaving drug epinephrine during emergency treatment of serious allergic reactions, including anaphylaxis.

“Based on the information provided by the manufacturer, the FDA anticipates the EpiPen shortage to be short-term,” FDA spokeswoman Lauren Smith Dyer said.

A statement from EpiPen producer Mylan N.V. on Tuesday confirmed “intermittent supply constraints.”

“However, product is available and Mylan is currently receiving continual supply from its manufacturing partner Meridian Medical Technologies, a Pfizer company,” the statement says.

Patients are encouraged to call Mylan’s customer relations line at 800-796-9526 for assistance, the statement notes.

“Mylan Customer Relations has been able to successfully locate alternative pharmacies for patients who are experiencing difficulty in accessing product,” spokeswoman Lauren C. Kashtan said.

Mylan said it informed the FDA a few months ago of the manufacturing delays.

“We are currently shipping product, and our shipments have been increasing over the last few months, with April shipments exceeding projections,” Pfizer spokesman Steve Danehy said. “Supply of certain third-party components, along with process changes,” have temporarily limited capacity at the company’s manufacturing facility.

Smith Dyer said the EpiPen shortage issue is “continuously evolving and fast-moving.”

The FDA will continue to update its website with supply information, she said. “This will include a list of epinephrine auto-injector products that are available from other manufacturers as well as contact information for consumers and health care providers,” Smith Dyer said.

Meanwhile, Spencer Williamson, president and CEO of pharmaceutical company Kaleo, said it is “able to fill and is filling” all order requests for the AUVI-Q, a competing pocket-size epinephrine auto-injection product, through its direct delivery service.

Patients with either commercial insurance or no insurance and a household income lower than $100,000 “can access AUVI-Q for $0 out of pocket,” Williamson said.

Dr. Len Horovitz, an internist at Lenox Hill Hospital in New York, offered his own alternative to the EpiPen shortage.

“We don’t have to depend upon a supplier for this particular drug,” he said.

Before auto-injector pens existed, he said, patients routinely used a do-it-yourself method.

“It’s relatively easy,” Horovitz said. Patients would draw doses of epinephrine from a vial and then keep a few loaded syringes in the refrigerator and take one with them. “Or go to your doctor, who would draw up several for you, and you store four in the fridge and carry one with you.”

Horovitz explained that you’d need a hard plastic container, such as the kind used for reading glasses, to carry the life-saving drug and that although it’s unclear how long it would last, epinephrine does not expire quickly, just as the auto-injector pens do not.

Patients also would not have to worry about air in the syringe causing an embolism. It is not an intravenous injection, so “a tiny bit of air” would do no real harm going into intramuscular tissue.

“To self-inject is very easy,” Horovitz noted. “Diabetics inject insulin.”