Primene 10% Amino Acid Injection, 250 mL, Pharmacy Bulk Pack - Compatibility Issue with Trace Elements

Starting date:

April 10, 2015

Posting date:

April 10, 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-52883

• Issue
• Who is affected
• Report health or safety concerns

Audiences

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 has received reports from a Canadian healthcare facility of discoloration and formation of a precipitate when Primene 10% solution is compounded with trace elements.
• Trace elements should not be compounded with Primene 10% solution until further notice is provided by Baxter. Depending on the clinical situation, trace elements can be infused separately.
• Infusion of a precipitate may lead to serious adverse effects including phlebitis, thrombophlebitis, thrombosis and major organ dysfunction.
• Existing TPN solutions with trace elements should be inspected for cloudiness or precipitation prior to administration and periodically during administration. Use only if the solution is clear, colourless or slightly yellow.

 

Issue

Primene 10% solution may not be compatible when compounded with trace elements. 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.

Products affected

The products of concern are:

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

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 should not compound trace elements with Primene 10% solution. Depending on the clinical situation, trace elements can be infused separately.

Existing TPN solutions with trace elements should be inspected for cloudiness or precipitation prior to administration and periodically during administration. Use only if the solution is clear, colourless or slightly yellow.

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@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 1-613-946-5636

Sincerely,

Original signed by

Danielle Tokarski
Sr. Quality Systems Manager
Baxter Corporation