,
The National Agency for Food and Drug Administration and Control (NAFDAC) is updating the public on some products found and reported to contain potent ingredients by various regulatory authorities overseas.
The implicated potent ingredients are not allowed in the affected products and may cause severe side effects on consumers. This information is provided to increase awareness on safety issues of such products found overseas, which may impact the local population.
The possible side effects of the potent ingredients
Betamethasone
Betamethasone 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 (characterised by the appearance of round face or ‘moon face’ and upper body obesity with thin limbs).
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.
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 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.
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.
Yohimbe
Yohimbe is a bark extract from which a potent medicinal ingredient, Yohimbine, is derived. Side effects associated with yohimbe or yohimbine include insomnia, anxiety, palpitations (sensation of heart pounding, racing or skipped beats), sweating and blurred vision. Overdosage can cause low blood pressure, rapid heartbeats, seizures, paralysis and coma. Deaths from overdose have also been
List of Products
Below is the list of the affected products;
| Name of product |
Picture of product |
Potent ingredient(s) | Source
(Regulatory Agency) |
|
Airee Beautycare Nigh Cream |
 |
Mercury |
Malaysia National Pharmaceutical Regulatory Agency |
|
Armila Beauty Kak ELL Pigment Booster |
 |
Betamethasone |
Malaysia National Pharmaceutical Regulatory Agency |
| Name of product |
Picture of product |
Potent ingredient(s) | Source
(Regulatory Agency) |
|
BL Ledehh Day Cream 1 |
 |
Hydroquinone and Tretinoin |
Malaysia National Pharmaceutical Regulatory Agency |
| DYNAMITE
Male Sexual Enhancement |
No picture available |
Sildenafil and Tadalafil
(PDE-5 inhibitors) |
United States
Food & Drug Administration |
|
Gen Bann Ultra, Testosterone Booster (red capsule) |
 |
Sildenafil (PDE-5 inhibitor) |
Health Canada |
|
Gen Bann Ultra, Testosterone Booster (black-red capsule) |
 |
Sildenafil (PDE-5 inhibitor) |
Health Canada |
| Name of product |
Picture of product |
Potent ingredient(s) | Source
(Regulatory Agency) |
|
Gen Bann Ultra, Testosterone Booster (red tablet) |
 |
Sildenafil (PDE-5 inhibitor) |
Health Canada |
|
Ginseng Red 2000 |
 |
Sildenafil (PDE-5 inhibitor) |
Health Canada |
|
Hard AF! |
No picture available |
Sildenafil and Tadalafil
(PDE-5 inhibitors) |
United States Food & Drug
Administration |
| Hard AF Black 3500mg Male Sexual Dietary Supplement
Pill |
No picture available |
Sildenafil and Tadalafil (PDE-5 inhibitors) |
United States Food & Drug Administration |
| NUX Male Enhancement |
No picture available |
Sildenafil and Tadalafil
(PDE-5 inhibitors) |
United States
Food & Drug Administration |
| ProPower
Knight Plus 2550mg |
No picture available |
Sildenafil and Tadalafil
(PDE-5 inhibitors) |
United States
Food & Drug Administration |
|
Revita Vita-X-2 |
 |
Caffeine and Tadalafil (PDE-5 inhibitor) |
Health Canada |
| Rhino products |
No picture available |
Sildenafil and Tadalafil
(PDE-5 inhibitors) |
United States Food & Drug
Administration |
|
Rhino 7 Platinum5000 |
 |
Sildenafil (PDE-5 inhibitor) and Yohimbe |
Health Canada |
| Name of product |
Picture of product |
Potent ingredient(s) | Source
(Regulatory Agency) |
|
Rhino 69 Extreme 600k |
 |
Sildenafil (PDE-5 inhibitor) |
Health Canada |
|
Rhino 69 Extreme 35000 |
 |
Tadalafil (PDE-5 inhibitor) |
Health Canada |
| Titanium 18K Male Sexual Enhancement
Black Silver |
No picture available |
Sildenafil and Tadalafil
(PDE-5 inhibitors) |
United States Food & Drug Administration |
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.
Although the product is not in NAFDAC database, members of the public are advised to exercise caution and vigilance by ensuring they;
- Avoid buying any of the products when
- Exercise caution when purchasing health products online or from unfamiliar sources (either local or overseas).
- Obtain all medical products from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
- 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.
Members of the public are hereby advised to check if they have in their possession any of the above listed products. If you are in possession of any of the products, you are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
