HSA updates on products found overseas that contain potent ingredients (October 2024)
The Health Sciences Authority (HSA) would like to update the public on products that have been found and reported by overseas regulators in October 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. Please refer to Annex A and Annex B for the list of products and the possible side effects of the potent ingredients. Please refer to the pdf document for images of the products.
HSA’s Advisory
2 Members of the public are advised to:
- Consult a doctor if you have consumed any of the products and are feeling unwell.
- Avoid buying any of the products when abroad.
- Exercise caution when purchasing health products online or from sources (either local or overseas) which you may not be familiar with, even if well-meaning friends or relatives have recommended them. You cannot be certain where and how these products were made. They may be illegal, counterfeit or substandard, and may contain potent ingredients which can harm your health. If buying health products online, we encourage you to buy them from websites with an established retail presence in Singapore.
- Be wary of products that promise quick and miraculous results or carry exaggerated claims like “100% safe”, “no side effects” or “scientifically proven”. Consumers should also be cautious of products that produce unexpected quick recovery of medical conditions.
- Consult your doctor or pharmacist if you need help for the management of your acute and chronic medical symptoms and conditions (e.g. diabetes, hypertension, eczema).
3 Additionally, members of the public are encouraged to visit https://www.hsa.gov.sg/consumer-safety/ to learn more about the dangers of buying health products from dubious sources.
4 Members of the public who come across the sale and supply of these products in Singapore may contact HSA's Enforcement Branch at Tel: 6866 3485 during office hours (Monday to Friday) or email: hsa_is@hsa.gov.sg.
Annex A
List of Products
Note: There may be different versions or variants of the products listed below. You are advised to consult your doctor or pharmacist if you are unsure of any health product you intend to use, or if you need help for your acute and chronic medical symptoms and conditions
| Name of product | Potent ingredient(s) | Source (Regulatory Agency) |
|---|
| 3800 Hard Rock | Tadalafil
(PDE-5 Inhibitor) | Heath Canada |
| African Vigorous Max Strength | Sildenafil
(PDE-5 Inhibitor) | Therapeutic Goods Administration |
| AK Forte Tablets | Dexamethasone, Diclofenac and Methocarbamol | United States Food and Drug Administration |
| Alien 2 Power Platinum 11000 (red) | Tadalafil
(PDE-5 Inhibitor) | Heath Canada |
Ácido Hialurónico
(or Acid Hyaluronic) | Diclofenac | United States Food and Drug Administration |
| Alien Power Platinum 11000 | Tadalafil
(PDE-5 Inhibitor) | Health Canada |
| Amazy | Diclofenac and Omeprazole | United States Food and Drug Administration |
| Bang Maximum Power | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Black Bull Extreme | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Black Mamba Premium Triple Maximum | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Body Shape Weight Loss System | Sibutramine and Phenolphthalein | United States Food and Drug Administration |
| Dnars Gold Debalen Cream (Night) | Hydroquinone, Tretinoin and Betamethasone | Malaysia National Pharmaceutical Regulatory Agency |
| E-gold | Paracetamol,
Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Fiona | Orlistat | Thailand Food and Drug Administration |
| Ginseng Red 2000 | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Grakcu Capsule | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Thailand Food and Drug Administration |
| Jaguar 30000 | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Kak Ell Krim Rawatan | Mercury | Malaysia National Pharmaceutical Regulatory Agency |
| Karisma Aqua Birds Nest | Hydroquinone | Malaysia National Pharmaceutical Regulatory Agency |
| Lanlay Revita Capsules Vita-X | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Lollipop | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Lucky Lady | Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Magnum Gold 24K | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Magnum XXL 500K | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Master Zone 1500 | Tadalafil
(PDE-5 Inhibitor) | Health Canada |
| MerSplus Dietary Supplement Product | Sibutramine | Thailand Food and Drug Administration |
| MILA COLOR / FRESH Lemon 10 COLOR EYESHADOW PALETTE (01) | Lead and Rhodamine B | Myanmar Department of Food and Drug Administration |
| MILA COLOR / Peach SWEET PALETTE MAKEUP SET | Lead and Rhodamine B | Myanmar Department of Food and Drug Administration |
| MILA COLOR / PRIMER EYEBROW Kit (03) | Lead | Myanmar Department of Food and Drug Administration |
| Pink Unicorn | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Premium Pro Power 3500 | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| ResErection! (blister) | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| ResErection! (round bottle) | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Rhino 7 Platinum 5000 | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Rhino 11 Extreme 500K | Tadalafil
(PDE-5 Inhibitor) | Health Canada |
| Rhino 69 Extreme 35000 | Tadalafil
(PDE-5 Inhibitor) | Health Canada |
| Rhino 69 Platinum 35000 | Tadalafil
(PDE-5 Inhibitor) | Health Canada |
| Rhino 69 Platinum 700K | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Rhino 69 7000K | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Rhino 99 diamond 30000 | Tadalafil
(PDE-5 Inhibitor) | Health Canada |
| Rhino for Her | Sildenafil
(PDE-5 Inhibitor) | Health Canada |
| Rush Hour 72 | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Skin Revolution - PAP - Blemish Control Serum | Clindamycin and Metronidazole | Malaysia National Pharmaceutical Regulatory Agency |
| Skin Revolution -PAP - Blemish Fade Cream | Clindamycin and Metronidazole | Malaysia National Pharmaceutical Regulatory Agency |
| Snow White Treatment Cream | Mercury | Malaysia National Pharmaceutical Regulatory Agency |
| Spanish Fly 20,000 | Tadalafil
(PDE-5 Inhibitor) | Health Canada |
| Spanish Fly 22,000 | Tadalafil
(PDE-5 Inhibitor) | Health Canada |
| Stiff Rox | Sildenafil and Tadalafil
(PDE-5 Inhibitors) | Health Canada |
| Trinity Gold | Acetaminophen, Diclofenac and Phenylbutazone (NSAID) | United States Food and Drug Administration |
| Ufora Daily Treatment 10g | Betamethasone | Malaysia National Pharmaceutical Regulatory Agency |
| Ziyinzhuangyang tablets | Sildenafil
(PDE-5 Inhibitor) | Therapeutic Goods Administration |
Annex B
The possible side effects of the potent ingredients
Acetaminophen / Paracetamol
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
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).
Clindamycin
Clindamycin is an antibiotic used to treat bacterial infections. It is a prescription medicine and should be used under medical supervision. Hypersensitivity reactions, such as skin rashes and urticaria, may occur with the use of clindamycin. Severe skin reactions, such as toxic epidermal necrolysis, have been reported with fatal outcomes. Other side effects associated with its use include severe stomach pain, changes in bowel habits, watery or bloody diarrhoea and renal dysfunction resulting in little or no urination.
Dexamethasone
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
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
Hydroquinone is a potent ingredient used in prescription medicines 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
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.
Mercury
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
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.
Metronidazole
Metronidazole is used to treat bacterial infections. It is a prescription medicine and should be used under medical supervision. Hypersensitivity reactions, such as skin rashes and urticaria, may occur with the use of metronidazole. Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with its use. Fungal superinfections may also occur with the inappropriate long-term use of metronidazole.
Orlistat
Orlistat is a medicine used in the management of obesity. This medicine should be used under the supervision of a healthcare professional. The inappropriate use of orlistat can cause headaches, abdominal pain, oily discharge from rectum, liquid stools, flatulence and fatigue.
Omeprazole
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.
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
NSAIDs are anti-inflammatory medications used to relieve pain and reduce inflammation. Their prolonged use may potentially cause serious gastric bleeding, nausea, high blood pressure and cardiovascular events such as heart attacks and strokes. They should be used under close medical supervision, especially in patients with underlying heart conditions, stomach bleeding and ulceration. Examples include aspirin, diclofenac, ibuprofen, indomethacin, mefenamic acid, meloxicam, phenylbutazone and piroxicam.
Phenolphthalein
Phenolphthalein may cause kidney disorders and has been found in animal studies to be associated with cancer. It may also cause breathing difficulties, rashes and abdominal cramps.
Phosphodiesterase Type 5 (PDE-5) inhibitors
This class of medicine 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
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
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.
Tretinoin
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.
Download PDF: HSA Foreign Alert_2024_October
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