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Products found to contain undeclared medicines

 
Singapore: HSA updates on products found overseas that contain potent ingredients (February 2025)
 
The Health Sciences Authority (HSA) would like to update the public on products that have been found and reported by overseas regulators in February 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 43 affected products listed in this announcement.

The possible side effects of the potent ingredients:
1,4-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.

Acetaminophen or paracetamol is used for relieving pain, headache and fever. Products which contain acetaminophen or paracetamol, but do not have this declared on the label, pose a danger to consumers as accidental overdose can result in liver damage.

Betamethasone 17-Valerate, clobetasol propionate and dexamethasone are potent steroids that are usually prescribed for inflammatory conditions and should only be used under strict medical supervision. Long-term unsupervised use of steroids (including topical use where the steroid can be absorbed into the body) can cause increased blood glucose levels (which may lead to diabetes), high blood pressure, cataracts, muscular and bone disorders, an increased risk of infections and Cushing’s syndrome (a round face or ‘moon face’ appearance 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, especially when the product has been taken for more than a few weeks.

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 include 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.

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. Desmethyl sibutramine is like sibutramine and may have similar side effects.

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-(february-2025)

In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Health Canada and the United States Food and Drug Administration, and was posted on the Drug Office website since 24 Apr 2024, with the latest update posted on 4 Mar 2025.

Ends/Friday, Mar 14, 2025
Issued at HKT 16:15
 
 
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