For those with severe allergies, the just-approved generic versionenough, with many allergy sufferers facing a supply shortage for the life-saving medicine.
Recent manufacturing disruptions and a spike in demand ahead of the start of the school year has left some areas in dire straits. Demand for EpiPens typically spikes in August, as caregivers buy multiple packs to give teachers, nurses and coaches when their kids return to classrooms. Adding to that difficulty is a price hike which left many struggling to afford.
Caregivers voiced their distress on social media, with one mother tweeting that her daughter was traveling to a remote part of Canada this weekend, taking two expired Epipens because they could not find a pharmacy with any supply. "I'm scared to death," she relayed.
While not everyone with allergies carries medicine to guard against anaphylactic shock, a severe reaction to food allergies or bee stings, nearly 6 million children have food allergies of some type in the United States, according to Food Allergy Research & Education. In an alert on the shortage, the advocacy group advised using an expired dose and then calling 911 for follow up medical treatment.
The EpiPen dominates the market for such devices, which expire 18 months after they're manufactured, as many insurance companies don't cover other epinephrine autoinjectors.
Meridian, the Pfizer subsidiary that makes the EpiPen "continues to experience manufacturing constraints affecting U.S. supply," the company said in an emailed statement. Pfizer is exploring options to help stabilize supply, but can't guarantee its availability at all pharmacies, it added.
"Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies," Mylan said in a statement last week. Reached for comment, a spokesperson said the company had nothing new to add.
The Food and Drug Administration last year determined Meridian failed to look into more than 100 complaints of the devices malfunctioning, including two cases involving fatalities. While Pfizer maintained at the time that there was no evidence the deaths were connected to the issue, it did make changes in its operations in response to a warning letter from the FDA.
The regulator on Thursday approved the first generic version of EpiPen, which Teva Pharmaceuticals expects to have on the market in coming months.