Pen Needle Problems Prompt FDA to Warn Consumers About Risk of Confusion

Amid concerns that problems with pen needles may be responsible for serious injuries associate with missed insulin shots, federal health regulators are warning consumers about the proper use of the devices designed to deliver medication through a pen injector. 

The FDA issued a safety communication on September 27, warning patients to exercise caution when using pen needles, after several patients reportedly experienced serious side effects from improper pen needle use. At least one patient died as a result of not receiving necessary medication after inadvertently using the pen needle incorrectly.

Pen needles are often used to inject insulin, involving a multi-dose injector. A new sterile pen needle is used each time to inject the insulin. However, it appears that confusion over the pen needles may be causing some users to miss doses.

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There are two common types of pen needles, the standard pen needle and the safety pen needle.

The standard pen needle has an outer cover that is removed, as well as a removable inner needle cover. Both pieces, or covers, are removed before a patient can use the pen needle for an injection.

The safety pen needle has an outer cover that is removed before an injection. However, the inner cover has a fixed shield that is not removed before an injection, in order to prevent injury.

The same pen injector can be used with both standard and safety pen needles.

The FDA indicates that it has received reports of patients using standard pen needles to inject insulin without removing the inner needle cover, when it should have been removed. In these cases the inner needle cover stopped the needle form entering the patient’s skin and the patient did not get the insulin.

Among the reports the FDA received, some patients developed high blood sugar, or hyperglycemia, because the inner needle cover stopped them from getting the much needed insulin.

At least one patient was hospitalized and later died after not receiving insulin. The patient had high blood sugar for too long a period of time.

Sometimes patients learn to use one type of pen needle, then receive the other type of pen needle later. This may contribute to the confusion about how to use the pen needle correctly. The agency recommends doctors and other healthcare providers provide certain guidance to patients who use pen needles.

  • For each new box of pen needles, check to see if the needles are the same type as what you were trained to use. If they aren’t, ask your doctor to show you how to use the new type of pen needle.
  • If using a standard pen needle with an outer cover and an inner needle cover, be sure to remove both covers before use.
  • If you feel medicine taken from a pen injector is not working, contact your doctor. Like in the case of diabetes, if your blood sugar levels are high after insulin injections, this may be a sign the injection was not done correctly.
  • If you have any questions about your pen needle, contact your doctor.

The FDA recommends doctors and healthcare staff show patients how to use the pen needle for their medication. They should always make sure the patient can demonstrate back to the doctor the proper technique to using the pen needle. Also, the patient should be aware there are different types of pen needles and what type they use specifically.

Adverse events related to pen needle use, either standard or safety needles, should be reported to the patient’s doctor and the FDA’s MedWatch Adverse Event Reporting Program.


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