被 發 現 含 有 未 標 示 西 藥 的 產 品
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| Singapore: HSA updates on products found overseas that contain potent ingredients (April 2025) (English only) |
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The Health Sciences Authority (HSA) would like to update the public on products that have been found and reported by overseas regulators in April 2025 to contain potent ingredients which are not allowed in these products and may cause side effects. This information is provided to increase awareness on safety concerns of such products found overseas, which could potentially affect the local population. There are 33 affected products listed in this announcement.
The possible side effects of the potent ingredients:
Betamethasone is a potent steroid. Long term use of an oral steroid without medical supervision can cause high blood pressure, cataracts, an increased risk of infections, and Cushing’s syndrome (characterised by the appearance of round face or ‘moon face’ and upper body obesity with thin limbs).
Dexamethasone is a potent steroid that is usually prescribed for inflammatory conditions and should only be used under strict medical supervision. Long term use of an oral steroid without medical supervision can cause high blood pressure, cataracts, an increased risk of infections, and Cushing’s syndrome (characterised by the appearance of round face or ‘moon face’ and upper body obesity with thin limbs). Discontinuation of steroids without proper medical supervision can cause serious withdrawal symptoms such as fatigue, confusion and low blood pressure.
Diclofenac is a potent painkiller and may potentially cause cardiovascular events such as heart attacks and strokes, as well as serious gastric bleeding, when used for a prolonged period. It should be used under close medical supervision, especially in patients with underlying heart conditions, stomach bleeding and ulceration.
Hydroquinone is a potent ingredient used in prescription medicines in Singapore for the treatment of skin conditions. The ingredient is prohibited in skincare cosmetic products and should only be used under medical supervision, as hydroquinone may cause harmful effects if not used properly. The inappropriate use of hydroquinone could result in changes in skin colour and hypersensitivity reactions such as rashes, redness, tingling and burning of skin.
Mercury is a toxic substance and is prohibited for use as an ingredient in cosmetic products. Regular application of creams containing mercury could lead to rash, skin discolouration and blotching. Chronic exposure to very high levels of mercury in cosmetic products may also cause toxic effects to the kidneys, digestive and nervous system, as it can be absorbed through the skin. This could lead to organ damage.
Methocarbamol is a medicine used to treat acute, painful musculoskeletal spasms. Common side effects include headaches, sleepiness and dizziness. Serious side effects may include anaphylaxis, liver problems, confusion and seizures.
Phosphodiesterase Type 5 (PDE-5) inhibitors includes avanafil, carbodenafil, sildenafil, tadalafil, vardenafil and their derivatives. These medicines can cause serious side effects such as strokes, heart attacks, decreased or loss of vision and hearing and priapism (painful and exceedingly long erections). If priapism is not treated immediately, it may lead to permanent impotence. PDE-5 inhibitors are also not suitable for patients with medical conditions such as certain heart-related problems or who are on heart medications such as nitrates. Deaths of patients found to be using sildenafil while on nitrates have been reported overseas.
Rhodamine B is a dye used for printing and dyeing of textiles, paper, paints and leathers. It is prohibited to be used in health products, including cosmetic products, as it may be carcinogenic. It can cause side effects, such as irritation, when in contact with the skin and eyes. Cases of permanent injury to the eye and chemical conjunctivitis due to exposure to the dye have been documented. When ingested, it may cause gastrointestinal irritation with nausea, vomiting and diarrhoea.
Tretinoin is a potent ingredient used in prescription medicines for the treatment of skin conditions and should be used under medical supervision. The ingredient is prohibited in skincare cosmetic products. Inappropriate use of tretinoin could lead to side effects such as redness and peeling of skin.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/hsa-updates-on-products-found-overseas-that-contain-potent-ingredients-(april-2025)
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Health Canada, Australia Therapeutic Goods Administration and the United States Food and Drug Administration, and was posted on the Drug Office website since 3 Apr 2025, with the latest update posted on 29 Apr 2025.
Ends/Tuesday, May 6, 2025
Issued at HKT 16:30
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