Vitalex for Men and Vitalex for Women

Starting date:

July 14, 2010

Posting date:

July 14, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Undeclared Substance, Unauthorized products

Audience:

General Public

Identification number:

RA-120001236

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.

U.S. Food and Drug Administration

Hong Kong Department of Health

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 M

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.

Yohimbine is a prescription drug that can affect blood pressure and the heart. It should only be taken under the supervision of a health care practitioner.

Indomethacin is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Indomethacin should only be taken under the supervision of a health care practitioner.

Sildenafil is a prescription drug used to treat erectile dysfunction. It should only be taken under the supervision of a health care practitioner.

Possible side effects

Side effects associated with yohimbine include tremors, sleep disorders, anxiety, abnormal blood pressure and heart beat, seizures, and kidney problems. Side effects associated with indomethacin include gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced blood clotting ability. Sildenafil should never 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 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.

What you should do

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.

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.

Background

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.

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.

Report a health or safety concern

• Call toll-free at 1-866-234-2345
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709