Federal officials are requiring new label warnings on multi-dose diabetes pens used to inject insulin and other medicines to reduce the risk of infection spread through sharing the devices, which are designed for use by single patients only.
The U.S. Food and Drug Administration noted such devices should never be shared among patients, even if the needle is changed, because it can lead to the spread of serious infections from one patient to another.
“To promote safer 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,’ ” the
FDA said in a statement.
Insulin and other injectable diabetes medicines are used top lower or regulate blood sugar, which, when uncontrolled, can increase the risk for serious complications — such as blindness, nerve and kidney damage, and heart disease.
Injectable diabetes medicines come in pen-shaped devices with either a reservoir or cartridge containing multiple doses of medicine. Each pen is designed for multiple uses by one patient only — with a new, fresh needle for each injection.
The FDA noted sharing pens can lead to transmission of infections such as the human immunodeficiency virus (HIV) and hepatitis viruses.
“Since 2008, we have 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,” the FDA said. “No confirmed cases of actual infection transmission have been reported, but sources of infection are often difficult to identify and may go unreported.”
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