Products found to contain undeclared medicines
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| Singapore: HSA updates on products found overseas that contain potent ingredients (December 2024) |
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The Health Sciences Authority (HSA) would like to update the public on products that have been found and reported by overseas regulators in December 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. There are 77 affected products listed in this announcement.
The possible side effects of the potent ingredients:
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.
Anabolic steroids are not approved for use to increase muscle mass or boost athletic performance. Taking such medication without medical supervision can be dangerous as they can cause serious side effects such as insomnia, irritability, aggressive behaviour, hypertension, liver cancer, development of prominent breasts in men and impotence. In women, they can cause male characteristics such as an increase in facial hair growth, male pattern baldness, deepening of the voice and menstrual irregularities. Examples of anabolic steroids are Boldenone undecylenate, Drostanolone propionate, Methandrostenolone (Metandienone), Nandrolone decanoate, Oxandrolone and Testosterone compounds.
The inappropriate use of caffeine may lead to insomnia, agitation, restlessness, palpitations, and increased heart rate.
Chlorpheniramine is an antihistamine used to relieve allergic reactions such as hives and rhinitis. Side effects from the use of chlorpheniramine include drowsiness, blurred vision, vomiting, constipation and poor coordination.
Clobetasol propionate is a potent steroid that is usually prescribed for inflammatory conditions and should only be used under strict medical supervision. Common side effects include skin irritation, pimples, redness and dry skin. Long term use without medical supervision can cause an increased risk of infections, allergic reactions and Cushing’s syndrome (characterised by the appearance of round face or ‘moon face’ and upper body obesity with thin limbs).
Dapoxetine is a prescription medicine used to treat conditions including depression and eating disorders, and it should be used under medical supervision. The use of dapoxetine has been associated with side effects including headaches, insomnia, palpitations and dizziness.
Dehydroepiandrosterone (DHEA), also known as prasterone, is a hormone that could increase the risk of prostate, breast, ovarian and other hormone-sensitive cancers. Side effects may include serious cardiovascular disease, changes in fertility and sperm production, hair loss, voice deepening, insulin resistance, changes in menstrual pattern, liver dysfunction, abdominal pain, and high blood pressure.
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.
Frusemide / Furosemide is a prescription medicine used to eliminate water and salt from the body and should be used under medical supervision. The side effects associated with its use include loss of appetite and low blood pressure. When taken in excess, the ‘water-eliminating’ effect of frusemide can cause the depletion of sodium, chloride, body water and other minerals in the body.
Glibenclamide / Glyburide is a prescription medicine used to treat diabetes mellitus and should be used under medical supervision. Inappropriate use without medical supervision may cause severe low blood glucose which can cause seizures or coma. Other side effects may include nausea, vomiting, diarrhoea and cholestatic jaundice.
Levodopa (L-Dopa) is a prescription medicine used in the treatment of Parkinson’s Disease and should be used under medical supervision. Levodopa may potentially interact with medicines used to treat high blood pressure. Side effects of levodopa may include low blood pressure, irregular heart rate and breathing abnormalities.
Fluoroquinolones are antibiotics used to treat bacterial infections. They are prescription medicines and should be used under medical supervision. Common side effects include nausea, vomiting, diarrhoea and rash. Severe side effects include an increased risk of tendon rupture, hallucinations and nerve damage. Examples include ciprofloxacin and levofloxacin.
Metformin is a prescription medicine for the treatment of diabetes and should be used under medical supervision. Common side effects include diarrhoea, nausea and abdominal pain. An overdose can cause severe hypoglycemia or lactic acidosis, which can be fatal.
Mitragynine is alkaloid of Kratom or Mitragyna speciose. The use of kratom has been associated with respiratory depression or decreased breathing, seizure, addiction and psychosis. Other side effects include high heart rate and blood pressure, trouble sleeping, and liver toxicity. When use is stopped, withdrawal symptoms may occur. Deaths have been reported with kratom both by itself and mixed with other substances.
Phosphodiesterase Type 5 (PDE-5) inhibitors include 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.
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.
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.
Terbinafine is a medicine used to treat fungal infections. Side effects associated with inappropriate use of creams containing terbinafine include skin peeling, itching, redness, and burning.
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-(december-2024)
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Health Canada, the United States Food and Drug Administration, Therapeutic Goods Administration and Hong Kong Department of Health, and was posted on the Drug Office website since 29 Nov 2024, with the latest update posted on 31 Dec 2024.
Ends/Friday, Jan 3, 2025
Issued at HKT 15:15
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