FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone

FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone
From FDA - August 4, 2017

Safety Announcement
Additional Information for Healthcare Professionals
Data Summary
List of Affected Adenosine and Amiodarone Products
IV Access Systems Known to be Incompatible with Adenosine and Amiodarone Pre-filled Glass Syringes
References

Safety Announcement

[05-06-2011] The U.S. Food and Drug Administration (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 (see Figures 1 and 2 below). 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.

Figure 1.


After connecting the glass syringe to the IV access system, the pin from the access system became clogged in the syringe tip

Figure 2.

Pin from IV access system removed from the syringe tip.

In November 2010, FDA issued a Letter to Stakeholders, alerting the healthcare community about the possibility of needleless pre-filled glass syringe malfunction. FDA, however, has continued to receive additional reports of adverse events related to syringe clogging and malfunction.

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

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.

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