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  • FDA Date: 05/06/2011

    Amiodarone Hydrochloride Injection FDA Drug Safety Communication

    Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is alerting the healthcare community about syringe connection problems when certain needleless glass syringes containing the cardiac drugs adenosine and amiodarone are used with particular types of intravenous (IV) access systems. The adenosine and amiodarone needleless pre-filled glass syringes and the IV access systems known to be affected by this announcement are listed below

    Adenosine and amiodarone are often used in emergency situations where immediate delivery of the medication is critical. These drugs are administered when a patient has a rapid or irregular heart rhythm in an attempt to return the patient's heart rhythm to normal.

    FDA has received reports that the adenosine and amiodarone pre-filled glass syringes can become clogged and malfunction during the process of connecting them to pin-activated needleless IV access systems. The incompatibility is not detected until after the syringe is inserted into the pin-activated needleless IV access system. The action of inserting the syringe can cause the pin in the access system to clog or break off in the syringe tip, preventing delivery of the medication. In some cases, the syringe may damage the IV tubing and/or the needleless access system and require reestablishment of IV access. These failures can cause a delay in administration of the medication in emergency situations, and could potentially result in serious harm to patients.

    Because of adverse event reports related to amiodarone in needleless pre-filled glass syringes, Sagent Pharmaceuticals, Inc., the manufacturer of the product, has voluntarily recalled all lots of the product to the user level.

    The manufacturers of currently marketed pre-filled glass syringes containing adenosine have revised the label to include a Caution statement in the Dosage and Administration section to inform healthcare professionals about incompatibility of the syringes with certain needleless IV access systems. A recall of all pre-filled glass syringes containing adenosine is not possible at this time because the current supply of adenosine in vials is not adequate to meet demand.

    FDA is continuing to evaluate this safety issue and is working with the product manufacturers to address the problem.

    List of Affected Adenosine and Amiodarone Products

    Drug Drug Manufacturer NDC Number of pre-filled glass syringe

    Adenosine Teva 00703-8781-23

    Adenosine Sagent 25021-0301-72

    Adenosine Baxter 10019-0063-08(07)

    Adenosine Wockhardt 64679-0630-01(02)

    Amiodarone Sagent/Gland 25021-0302-73

    View the full FDA Drug Safety Communication on FDA.gov