Health Canada, May 27, 2003
2003-35
May 27, 2003
Warning
Health Canada warns public not to use Hua Fo / VIGOR-MAX
OTTAWA - Health Canada is warning consumers not to use
Hua Fo VIGOR-MAX tablets, a Chinese herbal product that contains
tadalafil. Tadalafil is a prescription drug approved for sale for male
erectile dysfunction in the UK, Germany, Sweden, Denmark, Finland, New
Zealand, Australia and Singapore. It is not approved for sale in Canada.
Inappropriate use of Tadalafil could cause severe adverse reactions.
Tadalafil should not be used by individuals who are taking any
medication or other products containing nitrates: concurrent use could
result in the development of potentially life-threatening low blood
pressure. Also, tadalafil should not be used by patients with severe renal
or hepatic insufficiency.
Health Canada issued previous warnings on February 15, 2002 and April
5, 2002 concerning different lots of the product Hua Fo. These products
were found to contain sildenafil, or a compound similar, but not identical
to sildenafil, respectively. Like, tadalafil, sildenafil and its analogue
are used to treat erectile dysfunction. At the time, Health Canada
required the importer to remove the product from the shelves. Health
Canada is again requiring the importer to remove Hua Fo VIGOR-MAX from the
market and has issued a Customs Alert to stop the importation of the
product.
Hua Fo is manufactured in China and sold in Canada by Shenlong Natural
International Inc. The product (Hua Fo VIGOR-MAX Herbal Sexual Enhancer -
Natural) is packaged in white plastic bottles containing red coloured,
round, biconvex tablets. A red label indicates “300 mg. 30 tablets, Lot
Number 5444 Exp DE2007. Dosage: For adults only, take 5 tablets one hour
before intercourse.” Health Canada analyzed several tablets and found them
to contain tadalafil at an average concentration of about 3 mg per tablet
(normal concentration of Tadalafil is 10 mg or 20 mg).
Health Canada is issuing this warning to advise consumers, health care
professionals, and the provincial Ministries of Health of the safety
issues related to the use of Hua Fo VIGOR-MAX. Consumers are reminded to
consult with their health care practitioner if they have experienced any
adverse effects from taking Hua Fo VIGOR-MAX.
The text in this article was prepared by Health Canada.