Pfizer and Mylan Report EpiPen Label Defect Could Delay, Prevent Emergency Use

Regulatory NewsRegulatory News | 05 November 2018 |  By 

The US Food and Drug Administration (FDA) recently issued a safety alert to inform that EpiPen manufacturer, Pfizer, has become aware that the label sticker on certain auto-injectors “may have been improperly applied, causing resistance when removing it from the carrier tube.”
The safety alert affects Mylan’s EpiPen 0.3 mg and EpiPen Jr 0.15 mg containing labeled expiries on both the devices and cartons between June 2018 and February 2020 and between October 2018 and October 2019, respectively. It was issued late Friday, following a Pfizer-Mylan joint letter issued to health care providers to provide new precautionary handling instructions.
“If an auto-injector does not readily slide out of the carrier tube OR the label is not fully adhered to the auto-injector, the auto-injector should NOT be dispensed,” the new instructions state.
The letter from marketing authorization holder Mylan and a Pfizer subsidiary was issued 1 November to “inform health care providers and patients that in a very small number of cases” some of the affected auto-injectors and their authorized generic versions “may not easily slide out of their carrier tube, which could delay or potentially prevent use of the device during an emergency,” Pfizer spokesperson Steven Daheny told Focus, stressing that “the issue is with the device label and not with the device itself or the drug it delivers (epinephrine).”
The issue specifically involves labels getting stuck to the inside of carrier tubes as some were not fully adhered to the surface of the auto-injectors, according to the letter. “The probability of an auto-injector having a label that is not fully adhered is very low” but “delay in administration of EpiPen, EpiPen Jr and the authorized generic versions of these strengths, has a possibility of being associated with progression to a more severe allergic reaction,” the letter adds.
The labels affected by the new safety alert may block access to the affected EpiPen models, though the agency is unaware of any adverse events reports associated with this issue. “The lifted label defect has been discussed” with FDA and “corrective and preventive actions have been implemented to address the root cause of the issue,” according to the Pfizer-Mylan letter.
Manufacturing issues
Mylan and Pfizer have separately come under pressure to resolve issues around manufacturing.
FDA issued a warning letter last September to the Pfizer subsidiary, Meridian Medical Technologies, that manufactures the EpiPen, EpiPen Jr and authorized generic versions, which are regulated as device-led combination products.
Data from the subsidiary showed it had received hundreds of complaints that reported “EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died,” FDA said in the 2017 warning letter, noting that the follow-up to this issue “did not include removing potentially defective products from the marketplace.”
Meridian Medical Technologies had previously recalled all 13 lots distributed to the US that may have contained a potential deformity affecting the auto-injector component that “serves a critical role in the operation” of its EpiPen products but had only done so after the 2017 FDA site inspection at its facility in Missouri and “after multiple discussions with FDA,” the agency said.
The issues come as FDA granted an approval in August to Teva for the first generic versions of EpiPen and EpiPen Jr auto-injectors 0.3 mg and 0.15 mg strengths in the midst of an international shortage. FDA also approved extensions on expiration dates for specific EpiPen lots in August.

In recent discussions with Health Canada over the impact among Canadians, Pfizer Canada attributed the shortage to a manufacturing issue with the EpiPen 0.3 mg format. The Canadian Minister of Health has sought to alleviate the shortage of Pfizer's EpiPen 0.3 mg by permitting supplies of Auvi-Q in 0.15 mg and 0.3 mg doses.


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