TGA urges GPs to limit prescriptions to approved use for diabetes management amid surge in off-label demand
GPs are being asked to prioritise the diabetes medication Ozempic for people with the condition, after TikTok users began touting it as a weight loss treatment.
The Therapeutic Goods Administration earlier this month issued a joint statement with several medical bodies confirming a shortage of the injectable semaglutide medication, manufactured by the Danish pharmaceutical company Novo Nordisk, due to “unexpected increase in consumer demand”.
“The increased demand is due to extensive prescribing for obesity management, for which Ozempic is not indicated. The shortage is significantly affecting people using Ozempic for its approved use for type 2 diabetes,” the statement read.
The TGA urged health professionals to limit prescribing and dispensing of the medication to its approved use.
Ozempic grew in popularity on social media about the time the US Food and Drug Administration approved Wegovy, another injectable semaglutide medication by Novo Nordisk, for chronic weight management. It is currently being assessed by the TGA.
TikTok users have been documenting their weight loss using the hashtag #ozempic, which has garnered 74m views, as well as #ozempicjourney and #ozempicaustralia.
Several Australian users said they were able to access the medication via a prescription from their GP.
Royal Australian College of General Practitioners president, Dr Karen Price, warned there were side effects to using Ozempic to manage weight loss – such as nausea and vomiting – as well as contraindications if pregnant or breastfeeding.
“There are lots of issues people need to be aware of but most importantly, it’s not yet approved in Australia or the UK for weight loss. It’s being used off-label, which means that this huge demand is now stopping people who have a genuine need for the medication for their diabetes,” she said.
“Most people can see the ethical dilemma there.”
The Pharmacy Guild of Australia’s Victoria president, Anthony Tassone, confirmed supplies of Ozempic could remain low for weeks.
“I haven’t seen that medication in my pharmacy’s fridge for some time, unfortunately, and according to the medication shortage notices, stock may not be expected until mid-June,” he told reporters.
Tassone said he was concerned patients with diabetes were unable to access the medication, which helps to lower blood sugar levels when used in conjunction with diet and exercise.
“Pharmacists are doing everything they can to help patients by placing it on backorder or seeking it from other pharmacies, but [they] may need to refer patients back to the doctor for an alternative in the meantime,” he said.
“Medication shortages are sadly not a new thing. We’ve been experiencing them for years. But in this particular case, when it comes to diabetes, it is something of concern [and] we want to work with our patients and with GPs to ensure that patients have ongoing treatment to manage their condition.”
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Price said health advice offered on social media apps such as TikTok should be interpreted with caution.
“Often it’s very simplistically done, by non-medical people, and sadly it’s a very consumeristic approach to healthcare. Healthcare is never simple and it does need expert guidance,” she said, adding that GPs could work with patients on a tailored weight management program.
“Weight loss is complex, it does require a whole lifestyle approach – psychology, exercise, diet – and depending on what’s going on for that person, including their other medications and other medical conditions.
“There’s no miracle medication. It really is in the context of an overall lifestyle program.”
Price noted there were alternative medications that can be prescribed by GPs while the TGA assesses Wegovy.
“We need to leave this drug for those who’ve got diabetes and wait and see where the developments go,” she said.
This article was amended on 22 June 2022. An earlier version described the Danish pharmaceutical producer Novo Nordisk as a Dutch company.