HSA updates on products found overseas that contain potent ingredients (June 2021)
The Health Sciences Authority (HSA) would like to update the public on products that have been found and reported by overseas regulators in June 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)
|
Adam’s Secret Extra Strength 2000
|
Tadalafil (PDE-5 inhibitor)
|
United States Food and Drug Administration
|
BALANCE X
|
Sildenafil and Tadalafil
(PDE-5 inhibitors)
|
Cambodia Ministry of Health
|
Big Penis
|
Sildenafil (PDE-5 inhibitor)
|
Indonesian Food and Drug Authority
|
Black Gorilla
|
Sildenafil (PDE-5 inhibitor)
|
Indonesian Food and Drug Authority
|
Black Panther
|
Sildenafil (PDE-5 inhibitor)
|
Indonesian Food and Drug Authority
|
Boo Jin Brightening Day & Night Cream
|
Mercury
|
Thailand Food and Drug Administration
|
Brilliant Skin Essentials Whitening Facial Cream
|
Tretinoin
|
Malaysia National Pharmaceutical Regulatory Division (NPRA)
|
Buaya Jantan / TR. 003404242
|
Sildenafil (PDE-5 inhibitor)
|
Indonesian Food and Drug Authority
|
Ginseng Power 5000
|
Sildenafil and/or Tadalafil
(PDE-5 inhibitors)
|
United States Food & Drug Administration
|
Imperia Elita Vitaccino Coffee
|
Fluoxetine and Sibutramine
|
United States Food & Drug Administration
|
KLG
|
Sildenafil (PDE-5 inhibitor)
|
Indonesian Food and Drug Authority
|
Madu Klanceng / Depkes TR 063 659 731
|
Dexamethasone and Phenylbutazone
|
Indonesian Food and Drug Authority
|
Miss Slim
|
Sibutramine
|
United States Food & Drug Administration
|
MUA MAKEUP ACADEMY Professional Trio Eyeshadow
|
Lead
|
EU RAPEX (Ireland)
|
One Night Love
|
Sildenafil (PDE-5 inhibitor)
|
Indonesian Food and Drug Authority
|
Premium OrgaZen 7000
|
Sildenafil and/or Tadalafil
(PDE-5 inhibitors)
|
United States Food & Drug Administration
|
PS 21 Capsule
|
Simvastatin
|
Malaysia Ministry of Health
|
Shogun-X 7000
|
Sildenafil, Tadalafil and/or Vardenafil
(PDE-5 inhibitors)
|
United States Food & Drug Administration
|
Skin Magical Rejuvenating Set 3 – Rejuvenating Cream No. 3
|
Hydroquinone
|
Brunei Darussalam Ministry of Health
|
Thumbs Up 7 (Black) 25K
|
Sildenafil, Tadalafil and/or Vardenafil
(PDE-5 inhibitors)
|
United States Food & Drug Administration
|
Thumbs Up 7 (White) 11K
|
Sildenafil, Tadalafil and/or Vardenafil
(PDE-5 inhibitors)
|
United States Food & Drug Administration
|
Urat Seribu TR. 11082600024
|
Sildenafil (PDE-5 inhibitor)
|
Indonesian Food and Drug Authority
|
2WEEKS
|
Sibutramine
|
Hong Kong Department of Health
|
69MODE Blue 69
|
Sildenafil, Tadalafil and/or Vardenafil
(PDE-5 inhibitors)
|
United States Food & Drug Administration
|
Annex B
The possible side effects of the potent ingredients
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.
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.
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.
Phenylbutazone
Phenylbutazone is an anti-inflammatory painkiller and its prolonged use may potentially cause serious gastric bleeding, nausea and high blood pressure.
Phosphodiesterase Type 5 (PDE-5) inhibitors
This class of medicine includes sildenafil, tadalafil and vardenafil. 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.
Simvastatin
Simvastatin is a prescription medicine used to treat high cholesterol and should be used under medical supervision. The side effects associated with simvastatin use include constipation, muscle pain or weakness and stomach pain.
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 document: HSA Foreign Alert_2021_June3258 KB
Consumer, Healthcare professional, Industry member, Chinese Proprietary Medicines, Cosmetic products, Health supplements, Traditional medicines
Published:
Safety Alerts