HSA updates on products found overseas that contain potent ingredients (April 2023)

The Health Sciences Authority (HSA) would like to update the public on products that have been found and reported by overseas regulators in April 2023 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)
Alien 2 Power Platinum 11000	Tadalafil (PDE-5 inhibitor)	Health Canada
American Bangster Black Label Optimum Formula 4000	Tadalafil (PDE-5 inhibitor)	United States Food and Drug Administration
Bellissimo Instant Premix Coffee & Chocolate Drinks	Sibutramine	Hong Kong Department of Health
Bio-Love	Caffeine and Tadalafil (PDE-5 inhibitor)	Health Canada
Brilliant Skin Essentials Rejuvenating Facial Cream	Hydroquinone and Tretinoin	Health Canada
Dynamite Male Sexual Enhancement	Sildenafil and Tadalafil (PDE-5 inhibitors)	United States Food and Drug Administration
DYNAMITE SUPER Capsule 58,000 mg	Sildenafil and Tadalafil (PDE-5 inhibitors)	United States Food and Drug Administration
NUX Male Enhancement	Sildenafil and Tadalafil (PDE-5 inhibitors)	United States Food and Drug Administration
NORF 20	Acetaminophen, Salicylic acid and Theophylline	United States Food and Drug Administration
Pro Power Knight Plus 2550mg	Sildenafil and Tadalafil (PDE-5 inhibitors)	United States Food and Drug Administration
Rhino 69 Platinum 35000	Tadalafil (PDE-5 inhibitor)	Health Canada
Rhino 69 Platinum 700K	Tadalafil (PDE-5 inhibitor)	Health Canada
Spanish Fly	Tadalafil (PDE-5 inhibitor)	Health Canada
Tantra Jelly Herbal Jelly for Him	Sildenafil and Tadalafil (PDE-5 inhibitors)	United States Food and Drug Administration

 

Annex B

The possible side effects of the potent ingredients

Acetaminophen

Acetaminophen 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.

 

Caffeine

The inappropriate use of caffeine may lead to insomnia, agitation, restlessness, palpitations and increased heart rate.

 

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.

 

Phosphodiesterase Type 5 (PDE-5) inhibitors

This class of medicine includes 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.

 

Salicylic acid

Salicylic acid is a medication that can be used for dermatologic conditions. Rare but serious hypersensitivity reactions may occur with the use of topical dosage forms of salicylic acid. When taken orally, salicylic acid or in the form of salicylates such as aspirin, can cause side effects such as nausea, vomiting and stomach discomfort. Salicylate toxicity, resulting in tinnitus, hyperventilation, confusion and slurred speech can occur. Life-threatening toxicity can lead to hallucinations, seizures and eventual respiratory and cardiac arrests.

 

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

 

Theophylline

Theophylline is a prescription medicine used in the treatment of asthma and should be used under medical supervision. The use of theophylline has been associated with side effects including seizures, irritability, headaches, nausea and vomiting.

 

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_2023_April_FINAL550 KB

Published: 3 May 2023

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