The ADR reports received by HSA are not limited to that of western medicines. During the past two years, we found 15 reports related to the consumption of adulterated illegal traditional medicines. As some patients may not consider traditional medicines such as herbal remedies as “medicines”, healthcare professionals are reminded to ask patients about use of traditional medicines, when investigating suspected adverse reactions.
In recent months, the HSA has issued three media advisories alerting the public against taking the following three products which have been found to be adulterated with potent western medicinal ingredients.
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A) Santi Bovine Penis Erecting Capsule
The product was sent for analytical testing and found to be adulterated with about 32mg of sildenafil per capsule. A 76-year old male patient was reported to have experienced loss of vision in both eyes after taking Santi Bovine Penis Erecting Capsules bought from a roadside peddler. He had been taking the capsules for a few months but stopped for 20 days before he took another dose of three capsules two days before presentation of the adverse drug reaction. Clinical examination suggested bilateral posterior ischaemic optic neuropathy (PION) as the cause of visual loss. The patient has a medical history of hypertension, hyperlipidaemia and stroke, and was on atenolol, diltiazem and simvastatin. There have been rare worldwide reports of ischaemic optic neuropathy (ION) among patients using marketed phosphodiesterase type 5 (PDE-5) inhibitors such as sildenafil, tadalafil and vardenafil. The majority of sildenafil cases appear to be cases of non-arteritic anterior ischaemic optic neuropathy (NAION) unlike the local case. However, it is not certain whether these events are related directly to the use of PDE-5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or other factors.
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B) Urat Madu
Urat Madu, a Jamu medicine, was tested to contain sildenafil. Each capsule was found with about 48mg of sildenafil. A 55-year old male patient who had been taking the product had blurring of vision in his right eye for two months before consulting a doctor. The product bought in Batam was labelled to have aphrodisiac properties for persons with impotency. The patient was reported to be taking 1–2 capsules as and when required before sexual activities.
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C) Asam Urat Flu Tulang, PJ. Dewandaru
A 22-year old female patient was reported to develop drug hypersensitivity syndrome, characterised by erythematous rash, urticarial vasculitis, periorbital swelling, elevated white cell count, esinophilia and transaminitis. She was taking Asam Urat Flu Tulang, two capsules daily for four weeks and was not on other medications. The product labelled to contain mainly herbal ingredients was indicated to treat joint pain, rheumatism and arthritis. The product label advised to increase the dose to two capsules three times daily if needed. Upon laboratory testing, it was found to be adulterated with 22mg of diclofenac, 0.25mg of dexamethasone and 205mg of paracetamol per capsule. These amounts of active ingredients are within the normal therapeutic daily doses of each component.
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