Clinicians warned against prescribing Novo Nordisk’s diabetes drug for new patients

Pharma News: The Therapeutic Goods Administration (TGA) has strongly recommended clinicians exercise caution when initiating new patients on the diabetes medication Ozempic. This warning comes following advice from Novo Nordisk regarding continued supply disruptions expected to persist into next year.

This news comes on the heels of the TGA responding to investigations into the potential risk of suicidal thoughts and self-injury among patients taking obesity and diabetes medicines manufactured by Novo Nordisk.

Ozempic, a drug in diabetes management, contains semaglutide as its active ingredient, a component also utilised in Novo’s weight loss drug Wegovy. The anticipation surrounding Wegovy, registered in Australia but yet to hit the market, has prompted off-label use of Ozempic as a weight loss aid.

This surge in demand for semaglutide, partly driven by social media influence, has resulted in a scarcity of the GLP-1 receptor agonist, impacting the availability of Eli Lilly’s diabetes medicine Trulicity (dulaglutide), another GLP-1 receptor agonist.

Novo Nordisk communicated to TGA about the continued limited supply of Ozempic for the remainder of 2023 and the entirety of 2024. The company cited a rapid surge in demand, particularly for the lower dosage variants (0.25/0.5 mg), as the primary reason for the constrained supply.

“This additional demand is mainly attributed to a sharp rise in off-label prescriptions,” remarked TGA.

Notably, the demand for the lower dose aligns with the dosing regimen for Wegovy, wherein patients start with a 0.25 mg dose for the first four weeks before transitioning to 0.5 mg for weeks five to eight. Subsequently, the dose escalates to 1 mg, 1.7 mg, and 2.4 mg over the ensuing three months.

In response to the evolving situation, TGA, in consultation with clinical and patient groups through the Medicine Shortage Action Group, has updated its guidelines for healthcare practitioners in Australia. The regulator strongly urges doctors to refrain from initiating new patients on Ozempic “unless there are no suitable alternatives or there is a compelling clinical reason to do so.”

Moreover, TGA is urging healthcare providers to carefully evaluate whether patients currently using the Novo Nordisk drug can be transitioned to an alternative treatment option, in accordance with appropriate prescribing guidelines. This advisory seeks to navigate the evolving landscape of medication availability and prioritise patient care amidst ongoing supply disruptions.

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