FDA ALERT [03/19/2009]: The FDA is issuing this alert to remind healthcare providers and patients that insulin pens and insulin cartridges* (see description below) are never to be shared among patients.  Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens.

The FDA has received information that insulin pens may have been shared among numerous patients (two thousand or more) in one hospital in the United States from 2007-2009 (http://www.wbamc.amedd.army.mil/), and in a smaller number of patients in at least one other hospital.  Although the disposable needles in the insulin pens were reportedly changed for each patient, there is still a risk of blood contamination of the pen reservoir or cartridge.  Patients who were treated with insulin pens at the hospitals in question are being contacted by the hospitals, and are being offered testing for hepatitis and HIV.  Some of the potentially exposed patients have reportedly tested positive for hepatitis C; however it is not known if the hepatitis infection occurred through insulin pen sharing, or if those who tested positive had previously undiagnosed hepatitis C.

The current instructions for use for all insulin pens already state that the pens are not to be shared among patients.  The FDA reminds healthcare providers, healthcare facilities, and patients that each insulin pen (and each insulin pen cartridge) is designed for single-patient use only and is never to be shared among patients. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user. The FDA is working with the Centers for Disease Control (CDC), professional societies and healthcare organizations to reinforce patient and healthcare provider education about proper and safe use of insulin pens.

This information reflects FDA’s current analysis of data available to FDA concerning this drug.  FDA intends to update this sheet when additional information or analyses become available.