Labeling for Anaphylaxis Txs Updated to Include Injury, Infection Information

The labeling for several epinephrine injection products has been updated to include information regarding injection-related injury and serious infections at the injection site.

The new labeling states that to minimize the risk of injection-related injury to young children, caregivers should hold the child’s leg firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported in children who were uncooperative and kicked or moved during an injection. The injection can be given intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. 

Also, rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia, have been reported at the injection site following epinephrine injection. Clostridium spores may be present on the skin and introduced into the deep tissue with SC or IM injection; cleansing with alcohol does not kill the spores. To reduce the risk of infection, the epinephrine injection should not be injected into the buttock. Patients should be advised to seek medical care if persistent redness, warmth, swelling, or tenderness occurs at the epinephrine injection site.

Epinephrine is a non-selective alpha and beta-adrenergic receptor agonist and is available as a pre-filled autoinjector (ie, EpiPen, EpiPen Jr, Adrenaclick) for the emergency treatment of allergic reactions (Type 1) including anaphylaxis. 

Fore more information visit FDA.gov.