Two Illegal Products “Delima Raja Urat” and “Cao Gen Bai Lin Wan” [ 草根百龄丸] Detected to Contain Undeclared Potent Substances
The Health Sciences Authority (HSA) warns members of the public not to take two illegal health products detected to contain potent western medicinal substances. The first product is packaged as a Malay Jamu medicine labelled “Delima Raja Urat” and the second product is presented as a Chinese medicine labelled “Cao Gen Bai Lin Wan [草根百龄丸]”.
2 Two separate reports of serious adverse drug reactions were received from two general practitioners. Upon analytical testings by HSA's Pharmaceutical Laboratory, potent western medicinal substances have been detected in the two products.
3 Both products, “Delima Raja Urat” and “Cao Gen Bai Lin Wan” were bought from overseas by the patients and have not been found to be sold locally at retail shops. Members of the public should not consume any stocks of these products that they may have in their possession.
About the Products
4 “Delima Raja Urat” is tested to contain four potent undeclared western medicinal substances, namely dexamethasone, chlorpheniramine, pheniramine and sibutramine. The product is packaged in small plastic containers and its label makes claims to treat back pain, muscle pain, numbness, weakness and gout (See Annex A 1 and 2 in pdf version for the photograph of this particular product and its labelling).
5 “Cao Gen Bai Lin Wan” is tested to contain two undeclared potent western medicinal substances, namely dexamethasone and chlorpheniramine. The product is presented as Chinese traditional medicine and packaged in blister-foil and paper box with label claims for relaxing muscles, improving blood circulation and relieving pain” (See Annex A 1 and 3 in pdf version for photograph of this particular product and its labelling).
About the Adverse Drug Reactions
6 The first report is of a female patient who took the adulterated “Delima Raja Urat” for more than one month for pain relief. The patient subsequently suffered symptoms of raised blood sugar level, which developed into diabetes mellitus.
7 The second report is of an elderly man who took “Cao Gen Bai Lin Wan” for more than two months to relieve joint pain. He developed symptoms such as increased blood pressure, rapid weight gain, facial flushing and thinning of skin.
8 The symptoms seen in these two patients are consistent with the adverse effects of dexamethasone, a potent corticosteroid used to treat inflammatory conditions such as arthritis and asthma. The unsupervised and prolonged usage of dexamethasone is associated with serious adverse reactions such as muscle and bone damage, increased blood sugar, increased blood pressure, increased cholesterol and mental and mood disorders.
9 Chlorpheniramine and pheniramine are antihistamines used to treat allergy symptoms. Adverse effects associated with antihistamines include drowsiness, urinary retention, dry mouth, blurred vision, confusion and gastro-intestinal problems.
10 Sibutramine, an appetite suppressant used to treat obesity, has been associated with serious adverse effects such as increased heartbeat, increased blood pressure, hallucination and vision problems.
Public Advisory
11 HSA strongly advises anyone who has purchased these products not to consume them. In the event that they have consumed these products, they should seek medical advice if they feel unwell or are concerned about their health.
12 In the interest of public health and safety, HSA would like to highlight to consumers the risk of buying medicines and health products from dubious sources, locally or overseas, as there is no guarantee on the safety of these products. Consumers who develop any unexpected reactions to health products are advised to inform their doctors.
13 Anyone who comes across “Delima Raja Urat” or “Cao Gen Bai Lin Wan” being sold illegally is encouraged to report to HSA's Enforcement Branch at Tel: 6866 3485 (24-hour line) or Email: hsa_is@hsa.gov.sg
HEALTH SCIENCES AUTHORITY
SINGAPORE
17 JUNE 2009
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