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The Food and Drug Administration (FDA) is reminding health care professionals and patients that insulin pens and insulin cartridges should not be used to give medication to multiple patients.
In an alert issued on March 19, 2009, FDA says that sharing insulin pens could result in the transmission of human immunodeficiency virus (HIV), the hepatitis viruses, and other blood-borne diseases.
Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically hold enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty.
All insulin pens are approved only for single-patient use (one device for only one patient). They are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection.
FDA knows of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens was used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.
Patients who have been exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV. Some of the potentially exposed patients have reportedly tested positive for the hepatitis C virus, although it's not known if the virus was spread as a result of insulin pen sharing.
FDA, the Centers for Disease Control and Prevention, and professional organizations are working to address infection control issues related to insulin pens.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
FDA Press Release
www.fda.gov/bbs/topics/NEWS/2009/NEW01976.html
FDA Diabetes Information
www.fda.gov/diabetes/index.html
Information for Healthcare Professionals: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens www.fda.gov/cder/drug/InfoSheets/HCP/insulin_pensHCP.htm
FDA’s MedWatch Safety Alerts: March 2009
www.fda.gov/consumer/updates/medwatch032309.html
Date Posted: March 25, 2009
