FDA Issues Warning About Diabetes Medication Injection Pens

Miriam E. Tucker
Medscape Medical News

The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.

The measure is aimed at reducing potential transmission of infection from one patient to another when they share pen devices. There is a risk even if the needle is changed because blood can remain inside the pen, the FDA notes in an alert.

The warning applies to pen devices that deliver various insulins and insulin combinations, as well as pramlintide and the glucagonlike peptide-1 receptor agonists liraglutide and exenatide. "Pen devices for insulins and other diabetes drugs are not designed for use by more than one patient," the FDA states.

While no confirmed cases of actual infection transmission have been reported, there have been at least two incidents involving thousands of patients who were possibly exposed to bloodborne pathogens through the sharing of multidose insulin pens, according to the FDA.

In January 2009, 2114 patients were potentially exposed to bloodborne pathogens when injection pens were used by multiple patients at a US Army facility. A similar incident in August 2011 at the Dean Clinic in Wisconsin involved 2345 individuals.

In 2012, the Centers for Disease Control and Prevention launched the "One & Only Campaign" aiming to improve injection safety, and the Centers for Medicare & Medicaid Services notified its state and regional offices to survey healthcare facilities for the sharing of insulin pens. Despite those efforts, yet another incident involving 716 potential exposures occurred within the Veterans Health Administration in 2013.

The "for single patient use only" warning will appear both on the individual pens and on the cartons in which the pens are packaged. Warnings against sharing pens will also be added to the prescribing information and to the patient medication guides, patient package inserts, and instructions for use.


FDA Issues Warning About Diabetes Medication Injection Pens. Medscape. Feb 25, 2015.


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