|The Lantus SoloStar insulin pen will be affected by the new labeling requirements.|
The FDA is taking action to ensure that multidose insulin pens do not spread diseases by requiring the injectable devices to display the warning "For single patient use only."
More than 2,000 people with diabetes were potentially exposed to diseases from sharing a pen in separate facilities in 2009 and 2011, and more than 700 patients of the Veterans Health Administration were potentially exposed in 2013, the FDA says. The agency adds that while no confirmed cases of infection due to pen sharing have been reported, it is difficult to identify sources of infection and cases may go unreported.
The warning will appear on the labeling attached to the pens as well as the pen cartons, the FDA says. Additional warnings will also appear on the patient medication guides, patient package inserts and instructions for use.
Reasons for the inappropriate sharing of insulin pens include lack of awareness of the risks, lack of or poor training, missing medications, time constraints, and most importantly, a lack of appropriate warning labels, the FDA says.
The affected pens include Sanofi's ($SNY) Apidra and Lantus insulin medications, Eli Lilly's ($LLY) Humalog and Novo Nordisk's ($NVO) NovoLog. The complete list of affected drug delivery devices is provided in the safety notice.
This action is the latest component of the FDA's long-running campaign to tackle the problem. A safety alert was issued in 2009.
And in 2013, an FDA advisory committee recommended upgrading blood lancets from regulatory Class I to Class II, meaning they would require a 510(k) clearance. Blood lancets are used to make skin punctures such as a fingerstick performed during blood glucose monitoring.
- read the safety notice about the labeling change