The FDA said diabetes patients run a “serious risk of infection” spread through sharing the injector devices, which are intended for use by a single person only.
New labels must mark pens and packaging “for single patient use only”, as sharing the medicines can be dangerous even if the needle is changed between users. Further warnings will be added to the prescribing information, package inserts, and instructions for use.
The rule applies to insulin and other injectable diabetes medicines used to lower or regulate blood sugar. The drugs come in pen-shaped devices with a reservoir or cartridge containing multiple doses of medicine.
They can be used several times with a fresh needle for each injection. Blood may enter the pen during use, making them unsuitable for sharing because of the risk of transmission of HIV or hepatitis.
The FDA said it was aware of thousands of patients “possibly exposed” to bloodborne infections in the last six years through sharing diabetes pens, although no cases of transmission were confirmed because “sources of infection are often difficult to identify and may go unreported.”
Affected diabetes medicines with multi-dose pen devices:
Humalog Mix 50/50
50% insulin lispro protamine and 50% insulin lispro
Humalog Mix 75/25
75% insulin lispro protamine and 25% insulin lispro
human insulin isophane
regular insulin human
70% human insulin isophane and 30% human insulin
human insulin isosphane
Novolog Mix 50/50
50% insulin aspart protamine and 50% insulin aspart
Novolog Mix 70/30
70% insulin aspart protamine and 30% insulin aspart