Health Canada Advises Canadians that Natural Health Products containing Glucomannan May Cause Serious Choking if Used with Insufficient Fluid

Starting date:

January 29, 2010

Posting date:

January 29, 2010

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Labelling and Packaging, Product Safety

Audience:

General Public, Healthcare Professionals

Identification number:

RA-110003825

• Media enquiries
• Public enquiries

Health Canada is advising Canadians that natural health products containing the ingredient glucomannan in tablet, capsule or powder form, which are currently on the Canadian market, have a potential for harm if taken without at least 8 ounces of water or other fluid. The risk to Canadians includes choking and/or blockage of the throat, esophagus or intestine, according to international adverse reaction case reports. It is also important to note that these products should Not be taken immediately before going to bed.

Health Canada has authorized some products containing glucomannan for the purposes of appetite reduction, weight management, treatment of constipation, management of cholesterol levels.

This advisory comes in light of Health Canada's action to work with manufacturers and distributors of products containing glucomannan to help ensure that these products are labelled appropriately with complete directions of use and cautionary statements. Should new safety information become available, Health Canada will provide an update to Canadians.

The required label information is as follows:

Directions for use

Take (or mix) this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product with insufficient liquid may result in choking and/or blockage of the throat, esophagus or intestine. Do not take immediately before going to bed.

Cautions and warnings

• Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding.
• Consult a healthcare practitioner prior to use if you have diabetes.

Contraindication

Do not use this product if you have difficulty swallowing.

Known adverse reaction

If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Consumers should consult with their health care practitioner if they still have any questions or concerns.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    AL 0701D
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709