New Delhi, Mar 07, 2015
Insulin pens and pens for other injectable diabetes medicines should not be shared among patients, even if the needle is changed, the United States Food and Drug Administration said, as it called for additional label warnings, prohibiting sharing of injectable medicines.
Sharing pens can result in the spread of serious infections from one patient to another, the regulator said.
And “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,’ ” it added.
Insulin and other injectable diabetes medicines help lower or regulate blood sugar, which, when uncontrolled, can increase the risk of serious complications, including blindness, nerve and kidney damage and heart disease.
Injectable diabetes medicines can come in pen-shaped devices with either a reservoir or cartridge containing multiple doses of medicine, it explained. Each pen is designed to be safe for just one patient and to be used multiple times with a new, fresh needle for each injection.
Pens must never be used for more than one patient because there may be blood in the pen after the patient uses it.
Sharing pens can lead to transmission of infections such as the human immunodeficiency virus (HIV) and hepatitis viruses.
The label warning of single-patient-use will appear on the pens and its cartons.
Additional warnings against sharing pens will also be added to the prescribing information and to the patient ‘Medication Guides,’ ‘Patient Package Inserts,’ and ‘Instructions for Use,’ the FDA said.
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