13 Different Insulin Pens Added To FDA Watch List Due To Users Missing This Important Step

We’ve all made mistakes. Maybe you’ve said “left” while pointing right, put your shirt on inside out and gone to work, or left your car keys in the refrigerator. But when you’re operating health equipment, like an insulin pen, for example, those embarrassing mistakes can be dangerous.

The FDA has noticed an unfortunate trend in the way insulin pens are being used: people aren’t removing the inner needle cover, and as a result the agency has placed thirteen different types of insulin pens on their list of drugs with potentially serious risks.

Photo: AdobeStock/ookean
Photo: AdobeStock/ookean

What drugs make the list is decided by what gets reported to FAERS, the FDA Adverse Event Reporting System. FAERS is a database that collects information on adverse events related to medications, and it’s designed to help the FDA keep tabs on medications already on the market. Adverse events are reported by healthcare professionals, consumers, and manufacturers. A report to FAERS does not necessarily mean a product is unsafe, but if the FDA identifies potential safety concerns based on the reports, they will conduct further investigation.

Every quarter, the FDA evaluates the FAERS database and issues a report identifying drugs with potential safety concerns, what those concerns are, and what next steps the agency is taking.

Photo: AdobeStock/diego cervo
Photo: AdobeStock/diego cervo

The most recent report, covering January to March 2018, listed 13 different types of insulin pen. The potential risk listed for each of them was “Product use error—failure to remove inner needle cover.”

The insulin pens on the January to March 2018 list are:

  • Apidra (insulin glulisine) injection
  • Basaglar (insulin glargine) injection
  • Fiasp (insulin aspart) injection
  • Humulin (human isophane insulin and human insulin) injectable suspension
  • Humalog (insulin lispro) injection
  • Lantus (insulin glargine) injection
  • Levemir (insulin detemir) injection
  • Novolog (insulin aspart) injection
  • Ryzodeg (insulin degludec and insulin aspart) injection
  • Soliqua (insulin glargine and lixisenatide) injection
  • Toujeo (insulin glargine) injection
  • Tresiba (insulin degludec) injection
  • Xultophy (insulin degludec and liraglutide) injection
Photo: Adobe Stock/skyfotostock
Photo: Adobe Stock/skyfotostock

The FDA is evaluating the need for further regulation. That regulation could be better labeling, pulling a product off the market, or doing nothing if a product is deemed safe. The FDA is eager to point out that drugs on the list, including the insulin pens listed above, have been identified for potential safety issues, but “it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”

A commenter on Diabetes Daily, Ed Woodrick, was concerned. “How in the heck do you not remove the inner cover? Are people shoving that in their body? Or are they touching it to the body thinking that the drug is magically getting in.”

Regardless of how the mistake is being made, using an insulin pen incorrectly is dangerous. There is both an inner and an outer cover, and someone should be trained until they are 100 percent sure of what to do before using one.

Photo: Adobe Stock/Photographee.eu
Photo: Adobe Stock/Photographee.eu

If you are unsure that you’re using your pen correctly, check with a diabetes educator, doctor, and/or pharmacist. You can also check with the pen’s manufacturer online to see if they have information or even a video available. We all do things incorrectly now and again, but when it comes to your insulin, it’s worth the time to double-check your process.

To check the status of other medications, you can take a look at the FDA’s quarterly reports.

Stay healthy, friends.

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