Health Canada, Nov 26, 2004
2004-59
November 26, 2004
Warning
Health Canada warns consumers not to use Male Power Plus
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.
The text in this article was prepared by Health Canada.