Bacitracin HPRC HEALTH CANADA APPROVED

Important Safety Information
Bacitracin for Injection (50,000 IU p
er vial) – Risk of Nephrotoxicity and
Anaphylactic Reactions

2020/12/21

Audience
Healthcare professionals including pediatricians, infectious disease specialists,
surgeons, critical care physicians, emergency physicians, pharmacists, nurses, and
intensive care unit (ICU) and emergency room (ER) medical staff.

Key messages

  • Serious cases of nephrotoxicity and hypersensitivity, including
    allergic contact dermatitis and/or anaphylaxis, have been reported
    in patients treated with bacitracin for injection following
    intramuscular and local administration.
  • Bacitracin for injection products are now contraindicated in
    patients with impaired renal function, including those taking
    nephrotoxic drugs.
  • Healthcare professionals are advised to:
    • evaluate renal function before initiating treatment with
      bacitracin for injection products, daily during therapy, and
      after treatment has stopped.
    • not use bacitracin for injection products concurrently with
      other nephrotoxic drugs.
    • not exceed the recommended daily dose. Maintain fluid
      intake and urinary output at proper levels to avoid
      nephrotoxicity.
    • discontinue bacitracin for injection products if nephrotoxicity
      or hypersensitivity reactions occur.
  • Healthcare professionals are reminded that bacitracin for injection
    products are NOT indicated as an irrigation solution for
    intraoperative prophylaxis nor for pre-soaking of medical devices
    or implants prior to surgery.
  • Health Canada is working with the manufacturers of bacitracin for
    injection products to update the Canadian Product Monographs to
    further strengthen the information about nephrotoxicity and to
    include information about anaphylactic reactions.

What is the issue?

Health Canada recently conducted a safety review and found there may be a link
between the use of bacitracin for injection products and the risk of nephrotoxicity
and hypersensitivity, including allergic contact dermatitis and/or anaphylaxis. Cases
of nephrotoxicity and serious hypersensitivity, including allergic contact dermatitis
and/or anaphylaxis, have also been reported when these products are used outside
of their authorized indications. Health Canada is working with the manufacturers to
update the Canadian Product Monographs for all bacitracin for injection products to
further strengthen the information about nephrotoxicity and to include information
about anaphylactic reactions.

Products affected

Brand/Product
Name
Dosage Form and
Strength
Manufacturer Drug
Identification
Number
(DIN)
BACIJECT Powder for Solution,
50,000 IU/ vial
SteriMax Inc. 02245571
BACITRACIN
USP
Powder for Solution,
50,000 IU/ vial
Pfizer Canada
ULC
00030708
BACITRACIN
FOR INJECTION*
Powder for Solution,
50,000 IU/ vial
Fresenius Kabi
Canada Ltd.
02255820
BACITRACIN
FOR INJECTION,
USP*
Powder for Solution,
50,000 IU/ vial
Auro Pharma
Inc.
02491109

*This product has been authorized for sale, but it is not marketed in Canada at this
time.

Background information

Bacitracin for injection products are indicated for intramuscular use in the
treatment of infants with pneumonia and empyema caused by staphylococci shown
to be susceptible to the drug.

Bacitracin solutions, applied locally in the form of compresses or instillations, may
be used once or twice daily in secondarily infected wounds, ulcers, pyodermas and
other superficial skin infections and in superficial infections of the eye caused by
bacitracin-susceptible organisms. Bacitracin solutions may be instilled into the nasal
cavities or administered by inhalation as an aerosol in the treatment of bacitracinsusceptible infections of the upper and lower respiratory tract. In severe or
extensive infections, appropriate antibacterial therapy should be given in addition to
local treatment with bacitracin.

Health Canada conducted a safety review and concluded that there may be a link
between the use of bacitracin for injection products and the risk of nephrotoxicity
and serious hypersensitivity, including allergic contact dermatitis and/or
anaphylaxis. This safety review was triggered by the United States Food and Drug
Administration (U.S. FDA) Drug Safety Communication dated January 31, 2020. In
that communication, the FDA requested all current U.S. manufacturers of bacitracin
for injection to voluntarily withdraw their product from the U.S. market. The FDA
review determined that U.S. healthcare professionals no longer use bacitracin for
injection, and considered the availability of other approved, effective treatments that
do not have the same serious risks, including nephrotoxicity and anaphylactic
reactions. Health Canada’s review did not include non-prescription bacitracincontaining products marketed as ointments since no safety concerns for these
products were identified in the U.S. FDA’s Drug Safety Communication.

Bacitracin for injection products are now contraindicated in patients with impaired
renal function, including those taking nephrotoxic drugs.

To further minimize risks in Canada, Health Canada, in collaboration with the
manufacturers of bacitracin for injection products, will update the Contraindications,
Warnings and Precautions (including the Serious Warnings and Precautions Box),
and Consumer Information sections of the Canadian Product Monographs for all
bacitracin for injection products. These updates will strengthen statements
regarding the risk of nephrotoxicity, including kidney failure, and include
information about serious hypersensitivity, including allergic contact dermatitis
and/or anaphylaxis, in patients exposed to bacitracin.

Health Canada will also work with the manufacturers of bacitracin for injection
products to collect information on utilization of these products and physician
awareness of these risks in Canada. After reviewing this information, Health Canada
will determine if further measures are needed to mitigate the risks.

Information for consumers

Bacitracin for injection products are prescription drugs used to treat:

  • infants with pneumonia and accumulation of pus in the chest (empyema)
    caused by staphylococci, a type of bacteria, when administered by injection
    into the muscle.
  • infected wounds, ulcers, large painful skin sores, and other surface skin and
    eye infections, when applied locally in form of compresses or drops.
  • upper and lower respiratory tract infections, when applied as nasal drops or
    administered by aerosol inhalation.

Bacitracin for injection products have been associated with side effects such as
serious kidney damage, including kidney failure (a condition where the kidneys
become unable to filter waste products from the blood), and serious allergic
reactions. Before and during treatment, patients should have blood tests done to
check their kidney function.

Patients need to seek immediate medical attention if they experience signs of:

  • kidney damage, including kidney failure such as back and abdominal
    pain, change in the colour of urine (pale or dark), decrease in amount of
    urine produced, nausea, pain or discomfort when urinating, swelling of the
    legs and ankles, tiredness, weight gain; or
  • allergic reactions such as difficulty breathing or swallowing, feeling sick to
    the stomach or vomiting, hives, itchy skin, rash, skin blisters, swelling of the
    tongue or throat.

Patients should discuss any questions or concerns about this information with their
healthcare professional.

Information for healthcare professionals
Bacitracin for injection products are NOT indicated as an irrigation solution for
intraoperative prophylaxis nor for pre-soaking of medical devices or implants prior
to surgery. Anaphylactic reactions and nephrotoxicity can occur when bacitracin is
used in this manner.

Bacitracin for injection products are now contraindicated in patients with impaired
renal function, including those taking nephrotoxic drugs.

Healthcare professionals are advised before prescribing or administering bacitracin
for injection products to:

  • ensure that patients are not hypersensitive to the drug or any ingredient in the
    formulation or component of the primary container.
  • determine that patients do not have impaired renal function and/or are not
    taking nephrotoxic drugs.

Healthcare professionals are also advised that:

  • serious hypersensitivity, including anaphylaxis and/or allergic contact
    dermatitis, in patients exposed to bacitracin following intramuscular and local
    administration may occur following the first dose. If hypersensitivity
    reactions occur, the drug should be discontinued.
  • close monitoring of renal function is recommended in patients treated with
    bacitracin. Glomerular and tubular kidney function must be evaluated and
    checked before commencement of therapy, as well as during and after
    treatment. Bacitracin should be used only where adequate laboratory
    facilities are available and when constant supervision of the patient is
    possible. The recommended daily dose should not be exceeded and fluid
    intake and urinary output maintained at proper levels to avoid kidney
    toxicity. If renal toxicity occurs, the drug should be discontinued.
  • concurrent use of other nephrotoxic drugs should be avoided.
  • bacitracin may cause renal failure due to tubular and glomerular necrosis due
    to high systemic absorption. Intramuscular use should be restricted to infants
    with Staphylococcal pneumonia and empyema due to organisms shown to be
    susceptible to bacitracin.

Action taken by Health Canada

Health Canada, in collaboration with manufacturers of bacitracin for injection
products, is working to update the Canadian Product Monographs to further
strengthen information about the risk of nephrotoxicity, including kidney failure,
and include information about serious hypersensitivity, including allergic contact
dermatitis and/or anaphylaxis.

Health Canada is communicating this important safety information to healthcare
professionals and Canadians via the Recalls and Safety Alerts Database
(https://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php) on the

Healthy Canadians Web Site. This communication will be further distributed through
the MedEffect™ e-Notice email notification system as well as social media channels
including LinkedIn and Twitter.

Report health or safety concerns
Health Canada’s ability to monitor the safety of marketed health products depends
on healthcare professionals and consumers reporting adverse reactions and medical
device incidents. Any case of nephrotoxicity, hypersensitivity, anaphylactic reaction
or other serious or unexpected side effects in patients receiving bacitracin for
injection should be reported to the appropriate manufacturer (see “Products
affected”) or Health Canada.

SteriMax Inc.,
2770, Portland Drive, Oakville, ON, L6H 6R4
Phone: 1-800-881-3550
Fax: 1-877-546-7667
E-mail: pv@sterimaxinc.com
Pfizer Canada ULC
17300 Trans-Canada Highway, Kirkland, QC
H9J 2M5
Phone: 1-866-723-7111
Fax: 1-855-242-5652
Auro Pharma
3700 Steeles Avenue West, Suite 402,
Woodbridge, ON, L4L 8K8
Phone: 905-856-8063; Ext.: 238
Fax: 905-856-8094
Email: pvteam@auropharma.ca
Fresenius Kabi Canada Ltd.
165 Galaxy Boulevard Suite 100, Toronto,
ON, M9W 0C8
Phone: 1-877-779-7760
Email: Canada_Vigilance@fresenius-kabi.com

 

To correct your mailing address or fax number, contact the appropriate MAH.

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
    (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) 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: hc.mhpd-dpsc.sc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Original signed by