Health Canada, Apr 5, 2002
2002-02
April 5, 2002
Warning
Health Canada warns public not to use Hua Fo (DIN 02243366)
OTTAWA - Health Canada is warning consumers not to use Hua
Fo tablets bearing the (Drug Identification Number) DIN 02243366,
after they were found to contain an unauthorized substance similar,
but not identical to, sildenafil. Sildenafil is a prescription drug
approved for male erectile dysfunction, sold under the brand name
Viagraź. Inappropriate use of sildenafil could cause severe adverse
reactions.
Health Canada issued a previous warning on February 15, 2002,
concerning a lot of non-DIN Hua Fo that contained sildenafil. At the
time, Health Canada required the importer to remove the product from
the shelves. Health Canada is again requiring the importer and
distributor to remove Hua Fo (DIN 02243366) from the market, and has
issued a Customs Alert, to stop the importation of the product. Both
the non-DIN and the DIN lots were sold in Canada by Shenlong Company
Ltd.
Given the close chemical structural similarity between
sildenafil and the substance identified in Hua Fo (DIN 02243366),
the known serious health risks associated with sildenafil could also
occur after using this product. Since this substance was not
approved in Hua Fo (DIN 02243366), the safety of the ingredient is
unknown and there may be other unknown risks associated with its
use.
Sildenafil should not be used by individuals who are
taking any nitrate medication or products. Nitrate medications are
commonly used for angina. Concurrent use could result in the
development of potentially life-threatening low blood pressure. In
extremely rare instances, use of sildenafil could result in penile
tissue damage and permanent loss of potency.
Hua Fo (DIN
02243366) is manufactured in China by Guizhou Ribulo Medical
Industry Inc. It is imported by Shenlong Company Ltd, and
distributed by T.C. Unicorn. The product is packaged in red and
yellow boxes. The boxes contain white plastic bottles with red,
round tablets. A red label bears the name Hua Fo with the following
directions for use: "300 mg. 30 tablets, Dosage: For adults only,
take 2 tablets orally not more than twice in 24 hours."
The label also has the following claim, which was approved for
this product, "This traditional herbal medicine can temporarily
restore mental alertness when experiencing fatigue or drowsiness."
The labelled contraindication is, "Do not consume if you are
pregnant or nursing women; child under 12; Adult with high blood
pressure."
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. To date, there have been
no adverse drug reactions reported to Health Canada involving the
use of Hua Fo. However, consumers who have used Hua Fo and have
concerns should contact their physicians.
The text in this article was prepared by Health Canada.