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# FDA Asks Labeling Change for Pen Needles
- URL: https://www.fdaweb.com/fda-asks-labeling-change-for-pen-needles/
- Published: 2018-09-27T12:00:00.000Z
- Updated: 2026-09-15T00:34:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142463

FDA is asking manufacturers of pen needles used with pen injectors to deliver medication to consider changing the labeling by adding a Warning that both the outer cover and the inner needle cover should be removed before an injection. The [letter](https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM621797.pdf?ref=fdaweb.com) says FDA is aware that in some cases, the inner needle cover is not removed prior to use, resulting in non-delivery of the intended medication. “FDA has received some reports of hyperglycemia and diabetic ketoacidosis, including one death, associated with failure to remove the inner needle cover when a standard pen needle was used to inject insulin,” the letter says.

An FDA [Safety Communication](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm621788.htm?ref=fdaweb.com) says that since the same pen injector can be used with both standard and safety pen needles, it is possible that patients could be taught using one type of pen needle and then receive the other type later. “This could cause confusion about how to use the pen needle correctly, and may prevent the patient from getting the medicine they need,” FDA says.

The Safety Communication says that one patient was hospitalized and died because of having blood sugar that was too high for too long.