The FDA recently issued a safety alert warning health care providers and patients not to share diabetes pen devices intended for single patient use – even if the needles are changed. The FDA will now add this warning to packages of pens containing diabetic medication, such as insulin.

Even if the needle is changed, pens may harbor traces of blood on other parts. That opens the possibility of transmission of bloodborne pathogens, including human immunodeficiency virus (HIV) and the hepatitis viruses.

The warning follows reports of thousands of patients possibly exposed to infections by shared pens, starting as far back as 2008. In January 2009, for example, a U.S. Army facility revealed that 2,114 patients were potentially exposed to bloodborne pathogens when insulin pens were used on more than one patient, according to the FDA. Following the incident, the FDA and other organizations sent safety alerts to health care facilities, health care providers, and patients. However, despite multiple communications by health authorities, errors continued to occur. The updated warning label is the latest attempt to stem the problem.

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Pen devices that will now carry the single-use warning include, by brand name: Apidra, Humalog, Humalog Mix 50/50, Humalog Mix 75/25, Humulin N, Humulin R, Humulin 70/30, Novolin N, Novolog, Novolog Mix 50/50, Novolog Mix 70/30, Lantus, Levemir, Symlin, Victoza and Byetta.

Health care providers are urged to educate their patients about safe use of pens, label injectable medications with the patient’s name if used in health care facilities, and train their staff.


  1. FDA News Release, Feb 25, 2015