Athri-Eze, Sear Heang Tienchi Tu Chung Wan, Wiku Jahe Kencur (Akur Mujarab), Cap Wijaya Kusuma (An Ki It)

Foreign Product Alert
2012-12
January 25, 2012
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

Singapore Health Sciences Authority (HSA)

Product Names

Athri-Eze
Sear Heang Tienchi Tu Chung Wan
Wiku Jahe Kencur (Akur Mujarab)
Cap Wijaya Kusuma (An Ki It)

Manufacturer / Place of Origin

Athri-Eze: manufactured bySeadragon Healthcare SDN BHD, No 184 Jalan Munshi Abdullah 75100, Melaka

Sear Heang Tienchi Tu Chung Wan: manufactured by Ge Lou Pai

Wiku Jahe Kencur (Akur Mujarab): manufactured by PJ. Ibnu Sabil, Cilacap (Indonesia)

Cap Wijaya Kusuma (An Ki It): manufactured by PJ. Ibnu Sabil, Cilacap (Indonesia)

Product Description

Athri-Eze is packaged in a bottle of 20 white capsules and promoted as a traditional Chinese medicine used to: "Improve circulation and dilate blood vessels to ease pain, as well as to treat the root cause. Ideal for rheumatoid arthritic pains, chronic or acute joint inflammation in the limbs, sciatica, complications from bone injuries, low back pain and other discomforts in the body."

Sear Heang Tienchi Tu Chung Wan is sold in a bottle of 40 black pills with a red label and promoted for:"Rheumatoid or general arthritis, low back pain, limb weakness."

Wiku Jahe Kencur (Akur Mujarab) is packed in foiled sachets of brown powder and promoted as a Malay Jamu medicine used to:"Relieve swollen legs or tingling sensation in the lower limbs, joint pain or stiff joints."

Cap Wijaya Kusuma (An Ki It) is packed in foiled sachets of brown powder and promoted as a Malay Jamu medicine used to:"Cure rheumatism, gout and toothaches. Eliminate the feeling of fatigue and lethargy. Relieve low back pain and improve the immune system. For both men and women."

Athri-Eze and Sear Heang Tienchi Tu Chung Wan

Wiku Jahe Kencur (Akur Mujarab) and Cap Wijaya Kusuma (An Ki It)

Reason for Warning

The HSA warned consumers not to use these products after they were found to contain undeclared pharmaceutical ingredients:

Product	Undeclared Ingredient
Athri-Eze	dexamethasone furosemide acetaminophen
Sear Heang Tienchi Tu Chung Wan	dexamethasone chlorpheniramine
Wiku Jahe Kencur (Akur Mujarab)	allopurinol prednisolone chlorpheniramine
Cap Wijaya Kusuma (An Ki It)	phenylbutazone acetaminophen

Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions, while prednisolone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions.

Furosemide (identified as frusemide in HSA alert) is a diuretic (water pill) prescription drug used to remove excess fluid from the body, and allopurinol is a prescription drug used to treat high levels of uric acid in the body, gout and kidney stones.

Acetaminophen is an ingredient used in both over-the-counter and prescription drugs to treat fever and pain.

Dexamethasone, prednisolone, furosemide, allopurinol and prescription acetaminophen should only be taken under the supervision of a health care practitioner.

Chlorpheniramine is an over-the-counter antihistamine drug.

Phenylbutazone was previously used to treat pain, fever, and inflammation, but is no longer authorized for sale in Canada because of its association with bone marrow suppression, which makes the body unable to fight infection.

According to the HSA press release, the HSA investigated the products after receiving reports of side effects involving Singapore consumers:

Sear Heang Tienchi Tu Chung Wan:A patient in her 70's suffered symptoms of Cushing syndrome such as bloated face. She had been taking the product for over a year.

Wiku Jahe Kencur (Akur Mujarab) and Cap Wijaya Kusuma (An Ki It): A 70 year-old patient was hospitalized with symptoms of dizziness and low blood pressure when he stopped taking the products. According to the HSA, the side effects were likely caused by the sudden withdrawal of prednisolone (found in the product Wiku Jahe Kencur (Akur Mujarab), which the patient had been taking for about a year).

Possible Side-Effects

Side-effects associated with dexamethasone and prednisolone 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.

Side-effects associated with furosemide include muscle cramps, dizziness, low blood pressure, headache and nausea.

Side effects associated with allopurinol include skin rash, and itching or swelling of the lips or mouth. Other side effects associated with allopurinol include gastric (stomach) symptoms such as diarrhea, abdominal pain, nausea and vomiting.

Long-term use of high doses of acetaminophen may cause serious liver damage.

Side-effects associated with chlorpheniramine include drowsiness, dizziness, confusion and blurred vision.

Additional side-effects associated with phenylbutazone include reduced blood clotting ability, gastrointestinal bleeding and kidney failure.

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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.