US FDA labelling change to all diabetes pens to prevent HIV risk

By Fiona BARRY contact

- Last updated on GMT

A diabetes pen next to a traditional syringe. (Image: Blausen staff)
A diabetes pen next to a traditional syringe. (Image: Blausen staff)

Related tags: Pharmaceutical drug, Fda

The US FDA is requiring manufacturers to place label warnings on all multi-dose diabetes pens as patients continue to share the devices.

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:

Brand name

Generic name

Apidra

insulin glulisine

Humalog

insulin lispro

Humalog Mix 50/50

50% insulin lispro protamine and 50% insulin lispro

Humalog Mix 75/25

75% insulin lispro protamine and 25% insulin lispro

Humulin N

human insulin isophane

Humulin R

regular insulin human

Humulin 70/30

70% human insulin isophane and 30% human insulin

Novolin N

human insulin isosphane

Novolog

insulin aspart

Novolog Mix 50/50

50% insulin aspart protamine and 50% insulin aspart

Novolog Mix 70/30

70% insulin aspart protamine and 30% insulin aspart

Lantus

insulin glargine

Levemir

insulin detemir

Symlin

pramlintide acetate

Victoza

liraglutide

Byetta

exenatide

Related topics: Markets & Regulations, Regulations

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