Diabetes Pen Devices to Display Additional Warning Labels

The Food and Drug Administration (FDA) announced that multi-dose diabetes pen devices intended for single patient use only are now required to add additional label warnings prohibiting the sharing of these injectable medicines. Pen devices and pen cartons containing multiple doses of insulin must now display a warning label stating “For single patient use only.”

Since 2008, the FDA has discovered that thousands of patients may have been exposed to blood borne pathogens when insulin pens were shared with more than one patient. In response to these reports, the FDA and other organizations have issued multiple safety alerts to healthcare facilities, patients, and healthcare professionals.

Each pen is designed to be safe for just one patient to use multiple times with a new, fresh needle for each injection. Insulin pens and pens for other diabetes medications should never be shared with other patients even if the needle is changed because blood may be present in the pen after use. Sharing pens can lead to the spread of serious infections such as the human immunodeficiency virus (HIV) and hepatitis viruses.

The FDA recommends that healthcare professionals and hospitals counsel patients to never share their diabetes pens with another person. Pens should be clearly labeled with each patient’s name or other identifying information to minimize medication errors. Verify the pen with the name of the patient and other patient identifiers to ensure the correct pen is used on the correct patient. Ensure the identifying patient information does not obstruct the dosing window or other product information such as the product name, strength, and the warning statement “For single patient use only.” Educate staff members regarding the safe use of diabetes pens.

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The following diabetes medications are available in multi-dose pen devices: Apidra (insulin glulisine), Humalog (insulin lispro), Humalog Mix 50/50 (50% insulin lispro protamine and 50% insulin lispro), Humalog Mix 75/25 (75% insulin lispro protamine and 25% insulin lispro), Humulin N (human insulin isophane), Humulin R (regular insulin human), Humulin 70/30 (70% human insulin isophane and 30% human insulin), Novolin N (human insulin isosphane), Novolog (insulin aspart), Novolog Mix 50/50 (50% insulin aspart protamine and 50% insulin aspart), Novolog Mix 70/30 (70% insulin aspart protamine and 30% insulin aspart), Lantus (insulin glargine), Levemir (insulin detemir), Symlin (pramlintide acetate), Victoza (liraglutide), and Byetta (exenatide).

For more information visit FDA.gov.