Citing Disease Transmission Risk, FDA to Require Stronger Labels on Some Diabetes Injectors

Regulatory NewsRegulatory News | 26 February 2015 |  By 

The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices.

In a 25 February 2015 safety announcement, FDA said the new warnings are meant to "reduce the serious risk of infection" when users share insulin pens and other injectable diabetes medications, "even [when] the needle is changed."

"Sharing pens can result in the spread of serious infections from one patient to another," said FDA. "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,'" FDA explained.

While FDA's recommendations to avoid sharing needles or multi-use devices might appear to be common sense to many patients, the regulator says it has "learned of thousands of patients possibly exposed to infections that are transmitted through blood from the sharing of multi-dose pen devices for insulin and other injectable diabetes medicines" since 2008. None of these cases have been confirmed, it added.

The new labeling requirements come more than six years after FDA launched a drug safety information campaign aimed at healthcare professionals and meant to reduce the risk of disease transmission associated with the devices.

Affected diabetes products include Victoza, Byetta, Lantus, several Novolog and Humulin products, Levemir, Symlin and Apidra.

FDA's announcement does not contain any information regarding the details of the labeling change or the process by which it expects product manufacturers to submit labeling changes.


FDA Safety Announcement


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