Public Alert No. 30/2023 – Alert on Four Products found to Contain Potent Medicinal Ingredients Including Steroids and Banned Substances

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The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of a press release by Health Sciences Authority (HSA) Singapore, on four products found to contain potent medicinal ingredients including steroids and banned substances.

The implicated potent medicinal ingredients are not allowed in the affected products and may cause severe side effects on consumers. According to HAS, four consumers experienced adverse effects after taking three of the products.

Labouratory analysis conducted by HSA on the products revealed that they contained potent medicinal ingredients, including steroids, sibutramine (a banned weight loss medicine) and tadalafil (an erectile dysfunction medicine).

Product Information

Further details of the products as provided by HSA are as follows;

Possible Adverse Effects of Potent Ingredients Found in the Products

Dexamethasone and Prednisolone

Dexamethasone and prednisolone are potent steroids that are usually prescribed for inflammatory conditions and should only be used under strict medical supervision. Long-term unsupervised use of steroids can cause increased blood glucose levels (which may lead to diabetes), high blood pressure, cataracts, muscular and bone disorders, an increased risk of infections and Cushing’s syndrome (a round or ‘moon face’ appearance 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 that may potentially cause serious gastric bleeding, as well as cardiovascular events such as heart attacks and stroke when used for a prolonged period. Diclofenac should be used under close medical supervision, especially in consumers with underlying heart conditions.

Sibutramine

Sibutramine was a prescription-only medicine for weight loss but has been banned in Singapore since 2010 because of an increased risk of heart attacks and strokes. Other serious adverse effects including fast heart rate, hallucinations or hearing voices have also been reported by consumers who took slimming products adulterated with sibutramine.

Tadalafil

Tadalafil is a prescription medicine used to treat erectile dysfunction that should only be given under medical supervision. Inappropriate use of tadalafil is dangerous and can increase the risk of serious adverse effects, including heart attack, stroke, headache, migraine, irregular heart rate and priapism (painful and exceedingly long erections). Tadalafil can also pose serious risks to certain individuals, including those with heart-related problems. It can cause potentially life-threatening low blood pressure in those who are on heart medications, especially those containing nitrates.

PHOTOS OF PRODUCTS TESTED BY HSA

‘ENRU PLUS+’                                                   ‘HKT HERBA KURUS TRADISI’

 ‘PILL HUA LUO CIN TAN                            ‘Spinach GINSENG HERB SUGAR’

Although the products are not in NAFDAC database, importers, distributors, retailers and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the above mentioned product. The product authenticity and physical condition should be carefully checked. Members of the public in possession of any of the products should discontinue sale or use and submit stock to the nearest NAFDAC office.

Healthcare professionals and consumers are encouraged to report adverse events experienced with the use of the products to the nearest NAFDAC office, via pharmacovigilance@nafdac.gov.ng, E-reporting platforms available at www.nafdac.gov.ng or via the Med- safety application for download on android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management