Company Recalls Epi-Pens for Adults and Children in Nationwide Recall

After two reports of product malfunction from users outside the US, a device that can stop life-threatening allergic reactions in their tracks is being voluntarily recalled nationwide. Meridian Medical Technologies, the Pfizer company that with pharmaceutical company Mylan makes EpiPens (epenephrine injection) and EpiPen Jr, announced Friday that it’s pulling the products because of a possible defect related to the device’s auto-injector, which could fail to work or require too much force to work, the company said in a press release.

The voluntary recall affects 13 lots of EpiPen and EpiPen Jr Auto-Injectors in .3 milligram- and .15 milligram-strengths that were distributed between December 2015 and July 2016, Mylan said in its release. Generic versions aren’t included in the recall.

This latest issue, combined with the considerable expense of EpiPens, could help loosen the stranglehold Mylan has had in the allergy market.

“We should probably start referring to these gadgets as automatic epinephrine injectors, as there are now a few options,” says Dr. Girish Vitalpur, MD, an allergist-immunologist at Indiana University Health, noting that the generic version functions in the same way and is as effective as the EpiPen.

There are two other gadgets available, he says. Adrenaclick is sometimes called the generic EpiPen, but that label is inaccurate; it operates differently but is just as effective. CVS makes a generic Adrenaclick, which is likely the cheapest option, Dr. Vitalpur adds. And the AUVI-Q was recently reintroduced after being pulled from the market a few years ago because of malfunctioning devices.

Although EpiPen’s makers note that the number of faulty pens is likely small, a severe allergic reaction left untreated can be fatal, the Food and Drug Administration noted in its news release about the recall.

“Severe allergic reactions, called anaphylaxis, must be treated right away to … prevent serious, potentially life-threatening complications,” says Adam Bailine, spokesperson for the Asthma and Allergy Foundation of America, a nonprofit organization based in Landover, Maryland. “Epinephrine auto-injectors are prescription-based and are the only line of treatment for anaphylaxis.”

Children and adults with severe allergies – common ones include allergies to foods, medicines, insects and even latex --  who are at risk of anaphylaxis need two of these auto-injectors with them at all times, he says. The shot injected with these devices, epinephrine, is basically adrenaline, Bailine explains. When used properly, it causes blood vessels to tighten, which helps decrease swelling and increase blood pressure. Epinephrine also relaxes the muscles around the airways in the lungs, which helps to open up the airways, and prevents the release of additional allergic chemicals, further reducing the reaction.

The company advises users to check the lot number on the top of their EpiPen containers or on the auto-injector itself to see if the products are part of the recall. If they are, Mylan says to contact the company immediately to exchange them for free. Mylan says to keep recalled pens until you have replacements in hand, however, because the chance that they’re defective is low and the consequences of anaphylaxis are so grave.

Because untreated allergic reactions can be fatal, everyone living with the possibility of anaphylaxis should be able to recognize the signs and symptoms of of it and also have an allergy emergency care plan in place, Bailine says.

“It’s important also to know that sometimes after a reaction, there can be a second, more severe reaction within four to eight hours of the first one,” he says. “So it’s recommended that people be watched in the emergency room for several hours after anaphylaxis.”

-- Virginia Pelley


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