被 发 现 含 有 未 标 示 西 药 的 产 品
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| Singapore: HSA updates on products found overseas that contain potent ingredients (November 2024) (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 November 2024 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 issues of such products found overseas, which may impact the local population. There are 39 affected products listed in this announcement.
The possible side effects of the potent ingredients:
1,3-dimethylamylamine (DMAA) is a stimulant. The use of DMAA can lead to high blood pressure, shortness of breath, irregular heart rate, tightening in the chest, and heart attacks, as well as seizures.
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.
Clobetasol propionate is a potent steroid that is usually prescribed for inflammatory conditions and should only be used under strict medical supervision. Common side effects include skin irritation, pimples, redness and dry skin. Long term use without medical supervision can cause an increased risk of infections, allergic reactions 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.
Formaldehyde is not allowed as part of the composition of cosmetic products. Individuals sensitive to formaldehyde may experience headache, shortness of breath, skin and eye irritation with exposure to the substance.
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.
Lead is a toxic substance and poisoning can occur when it builds up in the body, often over months or years. It can cause long-term harm including kidney damage and increased risk of high blood pressure.
Lidocaine or lignocaine is a medicine used to decrease or eliminate the feeling of pain. The inappropriate use of products with high concentrations of lidocaine can cause low blood pressure and dizziness.
Methanol or methyl alcohol, also known as wood alcohol, is commonly used for industrial purposes. It can be toxic when absorbed through the skin, and dangerous when ingested. Prolonged exposure to methanol can affect the central nervous system and lead to side effects including nausea, vomiting, headache, blurred vision, blindness and confusion.
Omeprazole is a medicine used in the treatment of gastrointestinal diseases such as peptic ulcer disease, Zollinger-Ellison syndrome, and gastroesophageal reflux disease. Common side effects include nausea, vomiting, headaches, abdominal pain, and bloating. Long term use without medical supervision may increase your chances of serious side effects such as an increased risk of bone fractures, gut infections, and vitamin B12 deficiency.
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.
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.
Sibutramine, previously a prescription weight loss medicine used in the treatment of obesity, has been disallowed for sale in Singapore since 2010 due to increased risk of heart attacks and strokes. The use of sibutramine has been associated with serious side effects, including high blood pressure, irregular heartbeats, hallucinations, and mood swings.
Synephrine, when taken in combination with caffeine, can cause side effects ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and strokes.
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-(november-2024)
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by the United States Food and Drug Administration, Health Canada, Medicines and Healthcare products Regulatory Agency and Hong Kong Department of Health, and was posted on the Drug Office website since 6 Nov 2024, with the latest update posted on 23 Nov 2024.
Ends/Friday, Dec 6, 2024
Issued at HKT 14:45
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