FDA Drug Safety Communication

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FDA Date: 3/19/09

NovoLog (insulin aspart) FDA Drug Safety Communication

Information for Healthcare Professionals: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens

FDA is issuing this alert to remind healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. FDA recommends the following regarding insulin pens and insulin cartridges, and other reusable injector devices:

- Insulin pens containing multiple doses of insulin are meant for use by a single patient only, and are not to be shared between patients.

- Identifying the insulin pen with the name of the patient and other patient identifiers provides a mechanism for verifying that the correct pen is used on the correct patient, and can help minimize medication errors. Ensure the identifying patient information does not obstruct the dosing window or other product information such as the product name and strength.

- Be aware that the likelihood of sharing insulin pens and cartridges is increased when the pens are not marked with the patient name or other patient identifiers.

- The disposable needle should be ejected from the insulin pen and properly discarded after each injection. A new needle should be attached to the insulin pen before each new injection.

- Although the incident leading to this FDA alert occurred with insulin pens, the same risk may exist with shared use of any reusable injection device.

- Hospitals and other healthcare facilities should review their policies and educate their staff regarding safe use of insulin pens.

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov