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Public advisory

Archived – Health Canada warns consumers not to use Male Power Plus

Starting date:
November 26, 2004
Posting date:
November 26, 2004
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Unauthorized products, Undeclared Substance, Product Safety
Audience:
General Public
Identification number:
RA-11000252

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 ongoing 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

 

Media enquiries

Jirina Vlk

Health Canada

613-957-2988

Public enquiries

613-957-2991