HSA Alerts Public to Illegal and Adulterated Capsules That Have Caused Serious Adverse Reactions
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12 July 2012
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The Health Sciences Authority (HSA) alerts members of the public to illegal capsules that are being sold as herbal or traditional medicines to treat arthritic and joint pain, and promote blood circulation. To-date, two patients have suffered serious adverse reactions, one of whom was admitted to the Intensive Care Unit (ICU) after taking these capsules. Samples of these capsules were tested and found to contain an undeclared potent western medicine, dexamethasone. These capsules are also not adequately labelled and are not approved by HSA.
2 Three different case reports on these illegal capsules have been reported to HSA's Vigilance Branch. Investigations by HSA officers revealed that the capsules were bought from peddlers or from friends. The officers also detected that the implicated capsules appeared similar in presentation, which were either green-white or blue-white in colour, and packaged in transparent bottles. The label that comes with these capsules is presented as a slip of paper with a printed list of herbal ingredients (see Annex of pdf versionfor pictures and table of ingredients). Further investigations revealed that they were likely to be the same product.
3 Tests done at HSA's Pharmaceutical Laboratory confirmed that these capsules were adulterated with the same potent western medicine, dexamethasone. Dexamethasone is a very potent steroid used for anti-inflammatory purposes and should only be taken under strict supervision by doctors. It can cause serious adverse effects such as increased blood glucose leading to diabetes, high blood pressure, eye, muscular and bone disorders, and can cause serious symptoms upon withdrawal (more information on the adverse effects caused by steroids and withdrawal symptoms can be found in the Annex of pdf version). As such, members of the public who have consumed the above-mentioned coloured capsules should consult a doctor as soon as possible.
Case reports
4 The reported cases involved patients between 40 and 80 years of age. The patient who was in critical condition is a male in his 80s who bought the capsules from a peddler locally. He was diagnosed by a doctor to have developed serious complications of Cushing's syndrome after consuming the adulterated capsules for about one year for the relief of chronic back pain. He was warded in the ICU for complications resulting from chronic unsupervised steroid consumption.
5 The second patient, in his 40s, took the capsules which he purchased from his friend for pain relief of gout. As a consequence of long term consumption of the adulterated capsules, his bones were affected and he sustained a fracture requiring surgery.
6 The third case involved a female in her 50s who experienced rapid pain relief for her stiff neck after consuming only a few of the illegal capsules, which were obtained from a friend. Her family member immediately suspected that the product was adulterated and reported the case to HSA.
Public Advisory
7 Members of the public who have consumed the above illegal capsules should consult their doctors as soon as possible and not stop taking the product on their own to avoid symptoms of steroid withdrawal.
8 Associate Professor Chan Cheng Leng, Deputy Group Director of the Health Products Regulation Group, HSA says, “We are very concerned that there may be more cases of consumers who are taking these products that are unreported and who may not be aware of its serious consequences. Traditional or herbal medicines that claim to offer quick relief of chronic conditions such as back and joint pain, especially if they are poorly labelled or packaged often contain potent medicinal ingredients such as steroids. Consumption of steroids, such as dexamethasone, without medical supervision, can lead to very serious adverse effects.”
9 HSA takes a serious view against those engaged in the sale and supply of illegal health products and will take strong enforcement action against such persons. It is an offence for an unlicensed person to import, sell or possess for sale any product containing substances controlled under the Poisons Act, such as dexamethasone. Anyone found guilty of an offence under the Poisons Act is liable to a fine of up to $10,000 and/or imprisonment for a term of up to two years.
10 Members of the public who have encountered these illegal products or any other suspicious products are encouraged to report them to the Enforcement Branch of HSA at Tel: 6866 3485 or Email: hsa_is@hsa.gov.sg.
11 For updates on public health and safety matters, members of the public may also follow HSA at www.twitter.com/HSAsg.
HEALTH SCIENCES AUTHORITY
SINGAPORE
12 JULY 2012
