Welcome to the FDA Drug Safety Podcasts for health care professionals from the Division of Drug Information. On February 25, 2015, 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 FDA announced that it 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.”
Injectable diabetes medicines are used to help lower or regulate blood sugar and 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 HIV and the hepatitis viruses.
Since 2008, FDA has learned of thousands of patients possibly exposed to infections that are transmitted through blood from the sharing of multi-dose pen devices for injectable diabetes medicines. No confirmed cases of actual infection transmission have been reported, but infection sources are often difficult to identify and may go unreported. FDA and other organizations have launched campaigns and issued multiple safety alerts, including a 2009 FDA Health Care Professional Sheet.
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, the Patient Package Inserts, and Instructions for Use. Adverse reactions involving multi-dose diabetes pen devices should be reported to the FDA MedWatch program at www.fda.gov/medwatch.