FDA Warns About Insulin Pen Needle Confusion

-Linda Crasco/Linda C

The FDA recently issued a Safety Communication warning that some pen users, including insulin pen users, may be confusing pens with standard needles with pens with safety needles. As a result of this confusion, some pen users may think they are injecting medication when they are not.  

Both types of needles have removable outer covers, but standard needles have a removable inner shield, while safety needles have a retractable, fixed inner shield. According to the FDA, there have been instances of missed insulin doses due to failure to remove the inner needle cover on standard pen needles. In one extreme example, a patient died as a result of hyperglycemia because of this.

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The FDA advises that pen users check each new box of pen needles or pens to ensure the needles are the type they were trained to use, and call healthcare providers with questions about unfamiliar pen needles or if they experience unexplained high blood sugars after pen injections.

In addition, the FDA recommends that healthcare providers make sure pen users can tell the difference between safety needles and standard needles. Needle manufacturers are also being asked to review their labeling and training materials to ensure clarity.

Pediatric diabetes educator Jeannine Leverenz at Lucile Packard Children’s Hospital Stanford knows of one instance of a patient not receiving insulin because he was not removing the inner needle shield. Leverenz, who is part of the T1D Exchange Quality Improvement Collaborative, said she and her team attempt to prevent this issue by having patients demonstrate pen technique prior to issuing a pen prescription.

To read the FDA notice, click here.


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