Warning

2002-26
April 5, 2002

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 Viagra®. 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."

Picture of the product
Picture of the product

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.

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Chinese version

Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189

Public Inquiries:
(613) 957-2991