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

 

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

Facts about adenosine and amiodarone

  • Between January 2009 through August 2010, 3.6 million single items (vials, syringes, bottles, etc.) of adenosine were sold. Of these, vials accounted for around 82% and syringes accounted for around 18% of adenosine sales.1
  • Between January 2009 through August 2010, 10.3 million single items of amiodarone were sold. Of these, syringes accounted for less than 1%, vials accounted for around 61%, ampules accounted for around 3%, and tablets accounted for around 36% of amiodarone sales.1

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.

glass syringe tip close up
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 tip from IV

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.  

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

   

Additional Information for Healthcare Professionals  

    • Know that adenosine and amiodarone needleless pre-filled glass syringes are incompatible with certain needleless pin-activated IV access systems (see List of Affected Adenosine and Amiodarone Products below).
    • Stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or pre-filled plastic syringes, if possible. Healthcare professionals should read the label of the pre-filled plastic syringes to ensure they are compatible with the IV access systems.
    • Report adverse events or problems experienced with the use of needleless pre-filled glass syringes to the FDA MedWatch program, using the information at the bottom of the page in the "Contact Us" box.

   

Data Summary

On November 17, 2010, FDA issued a Letter to Stakeholders, alerting the healthcare community about reports of syringe breakage and malfunction with needleless pre-filled glass syringes containing adenosine and amiodarone. At that time, FDA received 57 reports involving adenosine and five reports related to amiodarone needleless pre-filled glass syringes. Many cases reported life-threatening outcomes due to a delay in administration of the medication to patients in emergency situations. 

Since the issuance of the Letter to Stakeholders in November 2010, FDA has received additional reports of syringe clogging and malfunction with pre-filled glass syringes containing amiodarone and adenosine. 

The manufacturer of the amiodarone needleless pre-filled glass syringes, Sagent Pharmaceuticals, Inc., 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 voluntary recall of the adenosine needleless pre-filled glass syringes has not been initiated at this time because there is not enough adenosine in vials to supply the market if all adenosine needleless pre-filled glass syringes are recalled. FDA is aware that the process for manufacturing sterile injectables is complex and involves a long lead-time relative to other drug dosage forms. 

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

 

IV Access Systems Known to be Incompatible with Adenosine and Amiodarone Pre-filled Glass Syringes 

Manufacturer/Distributor IV Access System
Hospira Lifeshield® CLAVE™ and MicroCLAVE® Connector
ICU Medical CLAVE® and MicroCLAVE® Connector

 

References 

  1. IMS Health, IMS National Sales Perspective™, Retail and Non-Retail Combined. January 2009-August 2010. Data extracted October 2010.

 

 

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