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News From the Food and Drug Administration
April 7, 2015

Diabetes: 1 Pen, 1 Patient

Author Affiliations

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;313(13):1306. doi:10.1001/jama.2015.2802

Pens that contain multiple doses of insulin or other diabetes medications must now display a warning label stating “for single patient use only,” the US Food and Drug Administration (FDA) recently announced.

Warnings against sharing pens also are being added to the prescribing information and to the patient medication guides, patient package inserts, and instructions for use, according to the FDA.

The pens are designed to be used multiple times by 1 patient, who should use a fresh needle for each injection. “Since 2008, we have learned of thousands of patients possibly exposed to infections that are transmitted through blood” from the sharing of such devices, the agency said in a statement ( “No confirmed cases of actual infection transmission have been reported, but sources of infection are often difficult to identify.”

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