Traditional Medicines Adulterated with Steroids

In recent months, the Pharmacovigilance Branch of HSA has received four reports of adverse drug reactions from our healthcare professionals, leading to the detection of adulterated traditional medicines.

Report on "Bao Ling Capsule"

In the first report, a general practitioner observed that a 52-year-old female patient had developed facial swelling, a buffalo hump, increased frequency of urine and enhanced thirst after consuming a product labelled “Bao Ling Capsule” (保灵丸) to relieve her symptoms of rheumatoid arthritis. The patient had consumed the product for about six months and reported that she purchased the product from a friend. The reporting doctor was certain that the patient did not have these symptoms before and Cushing's syndrome was suspected. The doctor also ruled out other possible contributory factors such as the consumption of other concomitant medicines.

The product sample was immediately sent to HSA for analysis. The analyses revealed the presence of three adulterants, namely betamethasone, hydrochlorothiazide and chlorpheniramine. The patient was reported to have taken three capsules daily, which corresponded to the therapeutic dose of each ingredient - betamethasone 2.7mg (therapeutic range: 0.5-5 mg daily), hydrochlorothiazide 51.3 mg (therapeutic range: 25-100 mg daily), and chlorpheniramine 11.5 mg (therapeutic range: 4 – 24 mg daily).

Report on "Air Ikan Haruan Extract"

In the second report, a 67-year-old female patient presented at the hospital with generalized malaise, widespread body aches, loss of appetite and sudden weight loss of 10 kg over 4 months. These unexplained symptoms prompted the doctor to enquire about the patient's medication history, which revealed that she was self-medicating with a traditional medicine labelled "Air Ikan Haruan Extract" for pain relief. The product was bought from Malaysia and patient had been taking it for more than one year until it was stopped recently.

Suspecting the presence of steroids in the product, the doctor submitted the liquid sample to HSA which was subsequently tested by the laboratory to contain dexamethasone at 0.093mg/ml. Based on the daily consumption of two tablespoons, the dose of dexamethasone consumed by the patient on a daily basis was 2.8 mg, which falls within the therapeutic range of 0.5 -20 mg daily.

Report on "Delima Raja Urat"

In the third report, a 50-year-old female patient showed elevated fasting blood glucose level on repeated tests and was diagnosed to have diabetes mellitus by her general practitioner. The doctor found out that the patient was taking a Jamu product labelled “Delima Raja Urat”, for relief of rheumatism and body ache for the past one month.

Upon testing, the product sample was found to contain dexamethasone and traces of chlorpheniramine, pheniramine and sibutramine. The patient followed the dosing on the product's label and took one capsule twice daily. This worked out to 1.0 mg of dexamethasone, 1.0 mg of chlorpheniramine, 1.6 mcg of pheniramine and 2.4 ng of sibutramine consumed on a daily basis. Except for dexamethasone, the other components were present at sub-therapeutic doses. 

The hyperglycaemic symptoms and development of diabetes could have been the adverse effects of prolonged intake of dexamethasone.

Report on "Cao Gen Bai Lin Wan"

In the fourth report, a 74 year-old patient developed Cushingoid features such as facial flushing, weight gain and thinning of skin after taking the product “Cao Gen Bai Lin Wan” (草根百龄丸) for relief of joint pain for more than two months.

The product was subsequently tested by HSA to contain dexamethasone and chlorpheniramine. The product's recommended dose of two pills taken twice a day worked out to 1.5 mg of dexamethasone and 4.7 mg of chlorpheniramine, which was a therapeutic dose unwittingly consumed by the patient on a daily basis.

HSA's advisory

Prolonged use of corticosteroids such as dexamethasone and betamethasone may cause myopathy, osteoporosis, adrenal suppression, Cushing's syndrome and obesity. Symptoms of abrupt steroid withdrawal may include myalgia, arthralgia and weight loss, which were the symptoms manifested by the patient in the second case report upon stopping the consumption of the adulterated product.

HSA would like to remind healthcare professional to consider the possible contribution of adulterated complementary health products when a patient presents with unexplained adverse symptoms without a plausible medical cause. Many patients may not proactively volunteer information on the consumption of such products to their healthcare professionals as they may not regard such products as medicines. A careful taking of patient's medical history is encouraged as it may elicit important and useful information relevant to the diagnosis of the patient's condition.

Published: 12 Aug 2009

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