THE TGA has issued a warning after testing a weight loss product, revealing significant discrepancies in its composition.
Marketed as 'Semaglutide 2.64mg/mL, L-carnitine 100mg/mL B12 .05mg/mL solution for SC injection 3', the vials contained 10 times the labelled amount of vitamin B12 (cyanocobalamin) and significantly less L-carnitine than advertised, with estimates ranging from 0.5-0.7mg/ml compared to the labelled 100mg/ml.
Semaglutide, a medication that requires a script, was allegedly compounded and distributed in blue-capped vials with a distinctive red solution, differing from its expected appearance.
TGA stated that this product was mailed directly to patients, bypassing pharmacies, which is not the standard practice for prescription medicine distribution.
The administration's investigation was prompted by a serious adverse event where a patient was hospitalised with peripheral neuropathy after a subcutaneous injection of this compounded semaglutide-like product.
The product in question has not undergone assessments for quality, safety or efficacy and is not listed on the Australian Register of Therapeutic Goods.
The origin of the product's manufacture remains unidentified.
Compounded fake semaglutide-like products can cause serious health risks, warned the TGA, particularly those created without professional oversight in potentially unsterile conditions.
The body has released compounding safety information specifically for semaglutide-like products to educate consumers and healthcare professionals.
Moreover, the regulatory body is urging community pharmacists to advise their customers to be extremely cautious when purchasing medicines from unknown online sources. JG
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