Warning November 26, 2004 For immediate release OTTAWA -Health Canada is warning consumers not to use Male Power Plus, a product used for erectile dysfunction that has not been authorized for sale in Canada. Male Power Plus was found to contain tadalafil, a substance not declared on the label. Those taking Male Power Plus are advised to stop consuming the product and to consult with their physician. Tadalafil has been authorized by Health Canada as a prescription drug. Products containing tadalafil should be available only with a prescription written by a practitioner licensed to practice in Canada. The use of such a product may require a physical check-up, directions of use and on-going monitoring by a physician. Consumption of this product could affect individuals who are using nitrates (medication for heart disease such as angina) or have health conditions such as uncontrolled arrhythmias, hypotension, uncontrolled hypertension, stroke and severe renal or hepatic insufficiency. Nitrate medications are commonly used to treat some types of heart disease such as angina. Concurrent nitrate and tadalafil use could result in the development of potentially life-threatening low blood pressure. In extremely rare instances, use of tadalafil may potentially result in penile tissue damage and permanent loss of potency. Male Power Plus, which lists Spectrum Partners Inc. on the label, is sold in capsule form and contains two capsules per pouch. The product is imported by Erofun Import and S.D. Variations in Canada. Health Canada has taken steps to confirm the product is removed from the Canadian market. Health Canada encourages consumers to use only drug products which have been issued a Drug Identification Number (DIN) or a Natural Product Number (NPN, or DIN-HM for homeopathic medicines). Before a drug can be sold in Canada, the manufacturer must first provide Health Canada with scientific evidence that the drug is safe and effective at meeting its stated claims of treatment. All authorized drugs sold in Canada carry an eight digit number, preceded by the letters DIN, NPN or DIN-HM on the label so consumers can distinguish between authorized and unauthorized drugs. There have been no reports of adverse reactions associated with the use of this product, and the department is taking steps to confirm that the product has been removed from the Canadian market. Consumers and health care professionals are urged to report adverse reactions to Health Canada by toll-free telephone at (866) 234-2345 or by toll-free fax at (866) 678-6789. For more information, please contact the nearest Regional Operational Centre. Regional Operational Centres: British Columbia, Alberta, Northwest Territories, Yukon Operational Manager 3155 Willingdon Green Burnaby, British Columbia V5G 4P2 Phone (604) 666-3350 or Fax (604) 666-3149 Manitoba, Saskatchewan Operational Manager 510 Lagimodiere Blvd Winnipeg, Manitoba R2J 3Y1 Phone (204) 983-5490 or Fax (204) 984-2155 Ontario, Nunavut Operational Manager 2301 Midland Ave. Toronto, Ontario M1P 4R7 Phone (416) 973-1600 or Fax (416) 954-4583 Quebec Operational Manager 1001 Rue St-Laurent Ouest Longueuil, Quebec J4K 1C7 Phone (450) 646-1353 or Fax (450) 928-4455 Atlantic Operational Manager Suite 1625, 16th Floor 1505 Barrington Street Halifax, Nova Scotia B3J 3Y6 Phone (902) 426-2160 or Fax (902) 426-6676 -30- Media Inquiries: Jirina Vlk Health Canada (613) 957-2988 Public Inquiries: (613) 957-2991
