HSA updates on products found overseas that contain potent ingredients (May 2021)
The Health Sciences Authority (HSA) would like to update the public on products that have been found and reported by overseas regulators in May 2021 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)
|
Burro en Primavera
|
Sildenafil and/or Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
Deeja Cosmetic Yulai Cream
|
Hydroquinone
|
Malaysia National Pharmaceutical Regulatory Agency
|
Deeja Cosmetic Laila Cream
|
Betamethasone 17-valerate and Mercury
|
Malaysia National Pharmaceutical Regulatory Agency
|
Deluxe Beauty – Ultra Lightening Cream Pearl Perfect Fairness
|
Mercury
|
Malaysia National Pharmaceutical Regulatory Agency
|
Imperia Elita Vitaccino Coffee
|
Fluoxetine and Sibutramine
|
United States Food and Drug Administration
|
Imperial Extreme 2000 Capsules
|
Sildenafil and Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
Imperial Gold 2000
|
Sildenafil and Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
Imperial Platinum 2000
|
Sildenafil and/or Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
MaxxZEN Platinum 12000
|
Sildenafil and Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
Poseidon Platinum 3500
|
Sildenafil and Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
PremierZen Black 5000
|
Tadalafil (PDE-5 inhibitor)
|
United States Food and Drug Administration
|
PremierZen Extreme 3000
|
Tadalafil (PDE-5 inhibitor)
|
United States Food and Drug Administration
|
PremierZen Gold 7000
|
Sildenafil and Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
PremierZen Platinum 5000
|
Sildenafil and/or Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
PremierZen Platinum 8000
|
Sildenafil and Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
Super Storm Vitam SS
|
Sildenafil (PDE-5 inhibitor)
|
Cambodia Ministry of Health
|
Thumbs Up 7 Blue 69K
|
Sildenafil and Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
Thumbs Up 7 Red 70K
|
Sildenafil and/or Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
Triple SupremeZen Gold 3500
|
Sildenafil and/or Tadalafil
(PDE-5 inhibitors)
|
United States Food and Drug Administration
|
Triple SupremeZen Plus 3500
|
Tadalafil (PDE-5 inhibitor)
|
United States Food and Drug Administration
|
Annex B
The possible side effects of the potent ingredients
Betamethasone 17-valerate
Betamethasone 17-valerate 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 (characterized by the appearance of round face or ‘moon face’ and upper body obesity with thin limbs).
Fluoxetine
Fluoxetine is a prescription medicine used to treat conditions including depression and eating disorders, and it should be used under medical supervision. The use of fluoxetine has been associated with side effects including headaches, insomnia, palpitations and dizziness.
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.
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.
Phosphodiesterase Type 5 (PDE-5) inhibitors
This class of medicine includes sildenafil and tadalafil. 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 (PDE-5 inhibitor) while on nitrates have been reported overseas.
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.
Download pdf document: HSA Foreign Alert_2021_May321 KB
Consumer, Healthcare professional, Industry member, Chinese Proprietary Medicines, Cosmetic products, Health supplements, Traditional medicines
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