Primene 10% Amino Acid Injection, 250 mL, Pharmacy Bulk Pack - Compatibility Issue with Trace Elements - Important Information Updates on All Lots

Starting date:
April 21, 2015
Posting date:
April 21, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-53019

Audience

Health professionals who provide care for infants and children receiving total parenteral nutrition (TPN), or who prepare TPN for administration to this population in the following settings: Pediatric hospitals or units and associated inpatient pharmacy departments, Neonatal intensive care units, Pediatric nursing staff, Emergency departments, Compounding pharmacies, Homecare nursing agencies, and other relevant areas.

Key messages

  • Baxter Corporation is providing an update to the Important Safety Information, issued on April 10, 2015, regarding the compatibility issue between Primene and trace elements.
  • Although the potential for discoloration and formation of a precipitate as a result of a suspected interaction between trace elements and Primene 10% remains, to ensure optimal patient therapy and safety, Baxter is now requesting that customers adopt the following practice:
    • All types of trace elements, including those mixtures that contain copper, compounded with Primene 10% solution MUST be administered to the patient using a 0.22 micron filter.
    • Piggyback lipids for infusion to the patient below the filter (Y-site).
    • Perform visual inspection for cloudiness or precipitation of the TPN solution, infusion set, catheter and in-line 0.22 micron filter after compounding, prior to administration and periodically during administration.
    • If discoloration or precipitation is observed in the TPN solution, the infusion set, the catheter or at the filter, DO NOT INFUSE or STOP THE INFUSION of the solution immediately. Perform blood level checks for copper (or other trace elements) where medically relevant.
  • Infusion of a precipitate may lead to serious adverse effects including phlebitis, thrombophlebitis, thrombosis and major organ dysfunction.
  • Baxter continues to investigate this issue and will provide further notices in collaboration with Health Canada.

               

Issue

There is potential for formation of a precipitate as a result of a suspected interaction between trace elements and cysteine. Formation of this precipitate may result in insufficient levels of cysteine and trace elements in TPN solutions. Deficiencies of cysteine or trace elements can lead to serious health consequences. Serious adverse effects are associated with the infusion of particulate matter. Infusion of a precipitate may lead to serious adverse effects including phlebitis, thrombophlebitis, thrombosis and major organ dysfunction.

Products affected

The products of concern are:

Product Code Product Name DIN Lot Number
FCA3CG133C29D Primene 10% Amino Acid Injection, 250 mL
Pharmacy Bulk Pack
02236875 ALL

Background information

Primene 10% solution is indicated as nutritional support for infants (including those of low birth weight) and young children requiring total parenteral nutrition via either central or peripheral infusion routes.

Baxter Corporation has received reports from customers indicating that when certain trace elements are added to Primene 10% solution, a precipitate may form. Baxter’s investigations suggest that the precipitation and discoloration is due to the degradation of cysteine during terminal sterilization of Primene 10% solution that results in the formation of hydrogen sulphide. The hydrogen sulfide can then react with copper ions in the trace elements when compounded, and produce copper sulfide precipitate. Baxter has not been made aware of any related adverse events or patient injury.

Who is affected

Information for consumers

For more information, caregivers of infants and children who receive TPN should contact their TPN provider.

Information for health care professionals

Healthcare professionals MUST administer Primene 10% Solution that has been compounded with trace elements using a 0.22 micron filter.  Piggyback lipids for infusion to the patient below the filter (Y-site). Perform visual inspection for cloudiness or precipitation of the TPN solution, infusion set, catheter and of the in-line 0.22 micron filter after compounding, prior to administration and periodically during administration. If discoloration or precipitation is observed in the TPN solution, the infusion set, the catheter or at the filter, DO NOT INFUSE or STOP THE INFUSION of the solution immediately. Perform blood level checks for copper (or other trace elements) where medically relevant.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada will be working with Baxter Corporation to update the Product Monograph to reflect this safety concern.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious adverse health consequences or other serious or unexpected side effects in patients receiving Primene 10% solution should be reported to Baxter Corporation or Health Canada.

Baxter Corporation
Attn: Pharmacovigilance
7125 Mississauga Road
Mississauga, ON, L5N 0C2

To report an Adverse Reaction, health professionals and consumers may call toll free:
Phone: 1-800-387-8399 ext 6607
E-Mail: canada_pharmacovigilance@baxter.com 
Fax: 1-855-767-4573

To correct your mailing address or fax number, contact Baxter Customer Care at 1-888-719-9955.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 1-613-946-5636

Sincerely,

Original signed by

Frank Shannon
Director, Quality
Baxter Corporation


For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.