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.”

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