Other safety alerts
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| Australia: Compounding safety information: semaglutide-like products |
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Therapeutic Goods Administration (TGA) announces that there is an emerging trend for telehealth providers to offer compounded semglutide-like products. Compounded semaglutide-like products are ‘unapproved’ therapeutic goods and have not been evaluated by TGA for safety, quality and efficacy. The US Food and Drug Administration (FDA) has recently warned consumers of the safety risk associated with the use of compounded products containing a salt formulation of semaglutide, including semaglutide sodium and semaglutide acetate. This warning follows an increase in adverse event reports after patients have been administered compounded semaglutide-like products.
Compounding is the manufacture of a medicine by a healthcare practitioner or pharmacist where the medicine is required for a particular patient, to meet the individual’s clinical needs, and a commercially manufactured medicine is not suitable. For example, compounding may be useful for young children or people who are unable to swallow tablets or capsules and where the liquid formulation has not been approved by regulatory authority.
To date, Novo Nordisk is the pharmacetucial company with TGA approved products containing semaglutide, identified under the trade name Ozempic and Wegocy. Consumers should be aware that compounded semaglutide-like products are not identical to the approved product Ozempic. Medical practitioners and pharmacists should consider their individual legal and professional responsibilities in prescribing and dispensing an ‘unapproved’ product including compounded semaglutide-like products.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-alerts/compounding-safety-information-semaglutide-products
In Hong Kong, compounded semaglutide-like products are not registered pharmaceutical products.
Ends/ Saturday, December 16, 2023
Issued at HKT 19:00
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