FDA warns of EpiPen safety issues

The FDA sent out a warning March 24 about issues with EpiPen auto-injectors that may prevent proper injection. 

Pfizer, which makes brand-name EpiPens, and Mylan, which makes generic versions, sent a letter to healthcare professionals dated March 23 alerting them that some EpiPens have a raised safety release that may make it difficult to remove the Epipen from its carrier tube. A raised safety release could also activate the device prematurely, which could delay or prevent emergency treatment. 

The drugmakers said the device also may fail if users use sideways force to remove the blue safety release instead of using two hands, as is recommended. The device could activate prematurely if the blue safety release is removed the wrong way. 

Pfizer and Mylan said a slight deformation on the rim of the carrier tube may cause the EpiPen to not slide out easily. 

The FDA stressed in its warning that it's important for healthcare providers, patients and caregivers to occasionally review the EpiPen user instructions and practice using a training EpiPen device. 

The agency also recommended EpiPen users inspect their devices to make sure the blue safety release isn't raised and to make sure it can easily be removed from its carrier tube. 

Pharmacists should also inspect EpiPens before dispensing them and shouldn't dispense any product that doesn't easily slide out of the tube or that has a raised blue safety release. 

The FDA said it is aware of adverse event reports associated with EpiPens but didn't say how many of them there were or how serious they were. 

Read the FDA's full news release here

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