FDA Issues Warning on Diabetes Injection Pens

The FDA has just issued a warning regarding multidose pen devices that are used for injecting diabetes medications. The warning requires that these pens are labeled as “for single patient use only.” This measure is focused at reducing potential infections that could be transferred between patients if multiple patients use the same device. The risk remains even if the needle on the pen is changed because blood can stay inside of the pen.


The warning has been applied to insulin and insulin combination pens. In addition, pramlintide, liraglutide and exenatide. The FDA warns that the pens are not designed to be used by more than one person.


As of 2009, there were over 2,000 patients that had been exposed to bloodborne pathogens after having using injection pens that had been used by multiple patients at a US Army Facility. A similar incident occurred in 2011 and also involved over 2,000 patients.


In 2012, the CDC started a campaign for improving injection safety. Despite these efforts, the incidents continued to occur with more than 700 that were exposed in 2013. The “for single patient use only” warning appears on both individual pens and cartons which the pens are packaged in. The warnings will also be added to patient medication guides, patient package inserts and instructions for use of the injection pends.

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