Reumofan Plus - Reumofan Plus Premium

Starting date:

December 21, 2012

Posting date:

December 21, 2012

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Important Safety Information

Audience:

General Public

Identification number:

RA-16379

• Images

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.

Source of alert

U.S. Food and Drug Administration

Product names

• Reumofan Plus
• Reumofan Plus Premium

Manufacturer / Place of origin

Reumofan Plus and Reumofan Plus Premium are manufactured by Riger Naturals and distributed by Samantha Lynn Inc.

Product description

These products are promoted for treating arthritis, muscle pain, osteoporosis, bone cancer and other conditions.

Reason for warning

The U.S. Food and Drug Administration (FDA) warned consumers not to use these products after they were found to contain the undeclared prescription drugs diclofenac sodium, methocarbamol and/or dexamethasone.

Oral diclofenac is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Methocarbamol is a muscle relaxant and is available over-the-counter and by prescription. Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions.

Prescription drugs should only be used under the supervision of a health care professional.

Although Reumofan Plus and Reumofan Plus Premium are not commercially available in Canada, Health Canada has received one adverse reaction report associated with the use of Reumofan Plus by a Canadian consumer who purchased this product outside of Canada. The patient experienced worsening of glucose (sugar) control, and swelling of the arms and legs after taking the product.

Since June 1, 2012, the FDA has received reports of death, stroke, severe gastrointestinal bleeding, dizziness, difficulty sleeping, high blood sugar levels, kidney and liver injury, and corticosteroid withdrawal syndrome, associated with the use of these products.

Possible side effects

Side effects associated with diclofenac include gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced blood clotting ability.

Side effects associated with methocarbamol include drowsiness and dizziness. These effects may impair a person's ability to drive safely or operate machinery. Methocarbamol may also affect kidney function if therapy lasts 5 days or more.

Side effects associated with dexamethasone include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders. Consult with your health care practitioner prior to stopping use, as sudden discontinuation of dexamethasone may cause symptoms of withdrawal.

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

Health Canada
613-957-2983

Images

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