Unauthorized natural health product “Remogen” containing ibogaine and the risk of abnormal heart rhythms

Starting date:

July 27, 2015

Posting date:

July 27, 2015

Type of communication:

Information Update

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Important Safety Information, Non-medicinal Ingredient, Undeclared Substance

Audience:

General Public

Identification number:

RA-54378

OTTAWA – Health Canada is advising Canadians that it has received a serious domestic adverse reaction report of abnormal heart rhythms associated with the ingestion of “Remogen” (containing ibogaine), an unauthorized natural health product in Canada that may pose serious health risks. Canadians who have used this product and have concerns about their health should speak with their healthcare practitioner.

Ibogaine is a natural ingredient with medicinal properties, originating from the root bark of an African shrub. There are no authorized health products containing ibogaine in Canada. . However, Health Canada is aware of cases in which ibogaine was reported to be used in the treatment of drug addiction  There have been international reports of serious adverse reactions associated with products containing ibogaine, including death, respiratory arrest, cardiac problems such as irregular heartbeat, seizures, and symptoms related to psychiatric and metabolic dysfunction.

Health Canada recently seized various unauthorized products containing ibogaine from Phytostan Enterprise Inc., a distributor in Quebec, sold under the names: "Remogen"; "Ibo + Plus"; "Endabuse"; and "Iboga". Phytostan Enterprise Inc. has agreed to stop selling and importing these unauthorized products.

Health Canada is also working with Canada Border Services Agency to help prevent the future importation of products containing ibogaine.

Health Canada is monitoring ibogaine products and related safety data and will take action where required.

Consumers are encouraged to report any adverse reactions associated with the use of these products to Health Canada. Canadians are also encouraged to report complaints about health products to Health Canada by calling toll-free to 1-800-267-9675, or complete an online complaint form.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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