OTTAWA — Health Canada says a Quebec-based company is voluntarily recalling its laxative product due to missing label statements related to duration of use, risks and warnings.
Produits Naturels Leblanc Inc. advised Health Canada of the voluntary recall.
The department says information missing from the label of Flat Stomach, a product contained within the Flat Stomach Concept Extra kit, may result in potential chronic use of aloe, which can lead to bowel dependence and electrolyte imbalance.
Flat Stomach has been authorized for sale by Health Canada under Natural Product Number (NPN) 80004927 for the purposes of relieving occasional constipation and maintaining intestinal flora.
The department says as part of the conditions allowing the product to be sold, the label was to include a cautionary statement advising consumers to first consult a health-care practitioner if they intended to use the product for more than five days.
The statement was not included on the label of the marketed product, and also presented “potentially severe risks” to the health and safety of Canadians following long-term use, says Health Canada.
Stimulant laxatives should not be taken for more than one to two weeks unless under the supervision of a health-care practitioner.
Chronic use of aloe products can irreversibly damage the intestine, and disturb electrolyte balances, leading to irregularities in heartbeats, muscular weakness, kidney failure and even death.
Flat Stomach, also contains a diuretic ingredient, which may increase the potential for adverse effects on blood electrolyte levels. To date, Health Canada says it hasn’t received reports of any adverse reactions regarding Flat Stomach Concept Extra.
However, individuals are asked to report suspected adverse reaction to these or other health products by contacting the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345.
Alternatively, they can complete a Canada Vigilance Reporting Form which can be sent by fax to 1-866-678-6789 or emailed to CanadaVigilance(at)hc-sc.gc.ca
Online:
www.healthcanada.gc.ca/medeffect