Reports of adverse reactions in patients with serious mental health conditions suspected in association with use of prescription medications and EMPowerPlushttp://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2007/2007_17-eng.php
February 28, 2007
OTTAWA - Health Canada is updating Canadians about adverse reaction reports it has received concerning the use of EMPowerplus, a vitamin mineral supplement, for serious medical conditions.
Health Canada has received nine case reports of serious adverse reactions associated with the use of EMPowerplus. Most of the adverse reactions relate to worsening of psychiatric symptoms in those patients with serious underlying mental health problems, such as bipolar disorder and depression. The worsening of these symptoms could be related to taking the product and discontinuing prescription medications or taking the product in conjunction with prescribed medications. As a result, Health Canada is advising consumers with these serious conditions that there is a potential risk to health associated with the use of the product EMPowerplus.
Health Canada is concerned about the health risk posed by this product's promotion, including unauthorized health claims, and medical advice being provided by non-medically qualified staff of Truehope Nutritional Support Ltd. to patients with serious medical conditions to discontinue their prescribed medications. This may result in serious adverse health consequences.
It is important to discuss the treatment of serious medical conditions with a medically qualified practitioner.
A Health Canada public advisory and an information bulletin were previously issued in 2003, concerning the use of EMPowerplus for the treatment of serious medical conditions. With the receipt of the adverse reactions, Health Canada remains concerned about the health risks associated with the use of this product.
Consumers requiring more information about this Health Canada Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction with this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C