FDA Warns Against Needleless Prefilled Glass Syringes of Adenosine and Amiodarone

The FDA has notified healthcare professionals about syringe connection problems when certain needleless glass syringes containing adenosine and amiodarone are used with particular types of IV access systems. The FDA has received reports that adenosine and amiodarone prefilled needleless glass syringes can become clogged and can malfunction during the process of connecting them to pin-activated needleless IV access systems.

To reduce the potential risks to patients, the FDA recommends that healthcare professionals and risk managers stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or prefilled plastic syringes, if possible. The FDA recommends that healthcare professionals read the label of the prefilled plastic syringes to ensure they are compatible with the IV access systems. The use of needleless prefilled glass syringes in emergency situations should be avoided, if possible.

The manufacturer of the amiodarone needleless prefilled glass syringes, Sagent Pharmaceuticals, has voluntarily recalled all lots of the product within expiration to the user level. Amiodarone injection will continue to be available in vials from other drug manufacturers. A list of the affected products can be found at www.fda.gov/Drugs/DrugSafety/ucm254215.htm.

Adenosine and amiodarone are cardiac drugs that are administered when a patient has a rapid or irregular heart rhythm in an attempt to return their heart rhythm to normal. Adenosine and amiodarone must be injected rapidly into the blood stream in emergency situations and this failure could delay treatment.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234219.htm.