FDA Drug Safety Communication

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FDA Date: 2/24/15

Multi-Dose Diabetes Pen Devices FDA Drug Safety Communication

FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients

In an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only, the U.S. Food and Drug Administration (FDA) is requiring additional label warnings prohibiting sharing of these injectable medicines. Insulin pens and pens for other injectable diabetes medicines should never be shared among patients, even if the needle is changed. Sharing pens can result in the spread of serious infections from one patient to another. To promote safe use, we are requiring that pens and packaging containing multiple doses of insulin and other injectable diabetes medicines display a warning label stating "For single patient use only."

Insulin and other injectable diabetes medicines are used to help lower or regulate blood sugar, which, when uncontrolled, can increase the risk for serious complications, including blindness, nerve and kidney damage, and heart disease. Injectable diabetes medicines can come in pen-shaped devices with either a reservoir or cartridge containing multiple doses of medicine. Each pen is designed to be safe for just one patient to use multiple times with a new, fresh needle for each injection. Pens must never be used for more than one patient because blood may be present in the pen after use. Sharing pens can lead to transmission of infections such as the human immunodeficiency virus (HIV) and hepatitis viruses.

Since 2008, we have learned of thousands of patients possibly exposed to infections that are transmitted through blood from the sharing of multi-dose pen devices for insulin and other injectable diabetes medicines. No confirmed cases of actual infection transmission have been reported, but sources of infection are often difficult to identify and may go unreported. In response to the reports of potential exposure, FDA and other organizations have issued multiple safety alerts, including a 2009 FDA Health Care Professional Sheet, and launched campaigns warning against the sharing of insulin pens.

The "For single patient use only" warning will appear on the labels affixed to the pens and on the pen cartons. Additional 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.

View the full FDA Drug Safety Communication on FDA.gov