Tromboject 1% and 3% (sodium tetradecyl sulfate) with Visible Particles
- Starting date:
- July 17, 2018
- Posting date:
- July 17, 2018
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Important Safety Information
- Healthcare Professionals
- Identification number:
Healthcare professionals including vascular surgeons, vein specialists, dermatologists, nurses and doctors trained in treating venous diseases
- Vials of Tromboject 1% and 3% may contain visible and insoluble particles. Inadvertent injection of particulate matter could result in serious risks to patient health.
Healthcare professionals are advised to:
- Use the product only when the benefits of Tromboject 1% and 3% therapy outweigh the risk of the treatment 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 an in-line, sterile, polyethersulfone (PES) filter of 0.2 micrometer pore size, 13 mm diameter.
Vials of Tromboject 1% and 3% may contain visible particles that are not soluble.
|Product Name||Active Ingredient Name||DIN||Code|
|Tromboject 1% Inj 10 mg/mL||Sodium Tetradecyl Sulfate||00511234||L0010049|
|Tromboject 3% Inj 30 mg/mL||Sodium Tetradecyl Sulfate||00511226||
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.
When Tromboject 1% and 3% must be used for reasons of medical necessity, administer the product with an in-line polyethersulfone (PES) filter of 0.2 micrometer pore size.
Investigations related to the manufacture of this product are ongoing.
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 a filter for syringe using a 0.2 micrometer, sterile polyethersulfone (PES) membrane, 13 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.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
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
Original signed by
For more informationThe 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.
- Date modified: