Vitalex for men and Vitalex for women

Foreign Product Alert
2010-122
July 14, 2010
For immediate release

Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects. More info

Source of Alert

U.S. Food and Drug Administration

Product Names

- Vitalex for men
- Vitalex for women

Manufacturer / Place of Origin

Vitapro Inc.

Product Description

Vitalex for men and Vitalex for women are promoted as "herbal sexual enhancement supplements."

Reason for Warning

The U.S. FDA Office of Criminal Investigations informed consumers that a man and his daughter (55-year-old Phu Tan Luong, also known as Peter Luong, and 26-year-old Helene Ngoc Bich Luong) were charged with distributing misbranded drugs called Vitalexfor men and Vitalex for women that had been marketed as "all-natural" versions of sexual enhancement drugs.

The Vitalex products were found to contain acetildenafil, which is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction and should only be taken under the supervision of a health care practitioner.

According to the U.S. FDA news release, the Luongs allegedly obtained the components of the Vitalex products from China and shipped the drugs from Orange County, U.S., throughout the U.S. and to other countries. The press release also stated that, while the U.S. FDA has shut down the company Vitapro Inc, Vitalex products continue to be sold over the Internet.

Possible Side-Effects

Sildenafil should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side-effects from sildenafil use such as heart attack, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

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Media Enquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.