Tromboject 1% and 3% (sodium tetradecyl sulfate) with Visible Particles - Update on the Use of Medical Grade Filters

Starting date:
September 12, 2018
Posting date:
September 12, 2018
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
New safety information
Audience:
Healthcare Professionals
Identification number:
RA-67742

Audiences

Healthcare professionals including vascular surgeons, vein specialists, dermatologists, nurses and doctors trained in treating venous diseases

Key messages

  • This update replaces the information previously communicated on July 17, 2018 regarding the presence of visible and insoluble particles in Tromboject 1% and 3% vials. When the products must be used for reasons of medical necessity, it is recommended to administer Tromboject 1% and 3% with sterile medical grade polyethersulfone (PES) filters of 0.22 micrometer pore size, and 25 or 33 mm diameter.
  • Inadvertent injection of particulate matter could result in serious risks to patient health.
  • Healthcare professionals are reminded to:
    • Limit the use of Tromboject 1% and 3% for medically necessary interventions or in conditions where there are no therapeutic alternatives for the patient.
    • Conserve product only for medically necessary use due to the anticipated drug shortage of all Tromboject formats.
    • As a risk mitigation measure, if the product must be used, administer Tromboject 1% and 3% with above recommended medical grade filters.

          

Issue

Vials of Tromboject 1% and 3% may contain visible particles that are not soluble.

Products affected

Product Name Active Ingredient Name DIN Code
Tromboject 1% Inj 10mg/mL Sodium Tetradecyl Sulfate 00511234 L0010049
Tromboject 3% Inj 30 mg/mL Sodium Tetradecyl Sulfate 00511226 L0010050
L0010051

Background information

Tromboject 1% and 3% are sclerosing solutions for intravenous treatment of varicose veins.

Tromboject 1% and 3% may contain visible particles that are not soluble. The insoluble particles in the intravenous injection solution may pose a potential serious risk to patients. Potential adverse effects related to the use of injectable products containing particulate matter include phlebitis, pulmonary emboli, and pulmonary granulomas.

Recent investigations conducted by Omega Laboratories confirmed that medical grade filters with the specifications below are acceptable for use with the product in this situation.

When Tromboject 1% and 3% must be used for reasons of medical necessity, administer the product with sterile medical grade polyethersulfone (PES) filters of 0.22 micrometer pore size, and 25 or 33 mm diameter.

Who is affected

Information for healthcare professionals

Tromboject 1% and 3% should be used only when the benefits of the therapy outweigh the risk of the treatment. Tromboject 1% and 3% use should be limited to medically necessary interventions or conditions for which there are no therapeutic alternatives for the patient.

When Tromboject 1% and 3% must be used for medical necessity reasons, administer the content of the vial through sterile medical grade filters for syringes using a 0.22 micrometer sterile polyethersulfone (PES) membrane and with 25 or 33 mm diameter. One filter should be used for each vial.

Anticipated shortage of all formats of Tromboject has been posted on the Drug Shortages Canada website (https://www.drugshortagescanada.ca/). The resupply date is unknown at this time. Restricting use to medically necessary situations will help conserve product for these important uses.

Action taken by Health Canada

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

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Tromboject 1% and 3% should be reported to Omega Laboratories Limited or Health Canada.

Laboratoires Oméga Limitée
11,177 Hamon, Montréal, Québec H3M 3E4
Telephone : (514) 335.0310 / 1.800.363.0584
Fax : (514) 339.1407
E-mail: pharmacovigilance@omegalabs.ca

To correct your mailing address or fax number, contact Omega Laboratories Limited.

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:

Regulatory Operations and Regions Branch

Telephone: 1-800-267-9675