The State’s health products regulator issued warnings to several general practitioners for breaching guidelines by “actively advertising” weight loss drug Ozempic.
Ozempic is licensed for the treatment of type 2 diabetes in Ireland but can be prescribed “off-label” as an obesity treatment.
It has been heavily promoted as a weight-loss drug by celebrities and social media influencers, leading to global shortages for obesity and diabetes patients amid huge demand in the last year.
Records show the Health Products Regulatory Authority (HPRA) has taken action over GPs promoting the drug, which breaches rules on advertising prescription-only medication.
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In a May 12th email, the HPRA told the Department of Health and Health Service Executive (HSE) it had written to GPs and clinics who were “actively advertising Ozempic for weight loss”, which it said “breaches advertising regulations”.
The regulator said one Dublin-based doctor had sought guidance on what wording would be acceptable, “which could indicate the GP service wants to continue to advertise in some form”, it said.
A spokeswoman for the HPRA said the regulator wrote to a “small number” of GPs who were breaching regulations on advertising prescription medicine, who all ceased the practice afterwards.
The Medical Council said it could not comment on whether it had received any complaints about GPs advertising the popular drug.
Correspondence between the HPRA and health officials, released to The Irish Times under the Freedom of Information Act, stated there was a “high level of concern” about Ozempic shortages earlier this year.
Mark Turner, HSE assistant national director, said there was a “strong suggestion” that off-label prescribing to obesity patients was “further challenging” supplies of the drug, which is taken by regular injection.
Darren Scully, a HPRA official working in medicines shortages, told other health officials on May 4th that supplies of the drug should be “equitably” distributed. “I really mean to diabetic patients, but as HPRA, it is challenging for us to be involved in clinical decisions,” he wrote.
In late April, Muiris O’Connor, a senior department official, convened an “urgent” meeting to discuss shortages of Ozempic.
In correspondence he said demand was likely being driven by “continued prescribing of the medicine for off-label purposes and new diabetic patient prescriptions”.
The department was aware of increased “black market attention” on social media about Ozempic, he wrote.
Following the meeting health authorities wrote to GPs to discourage “off-label” prescribing of the drug for obesity patients.
Obesity experts and GPs who specialise in the area have criticised the approach of health authorities as discriminatory, as they say it has put patients with diabetes ahead of patients with obesity.
Semaglutide, the active ingredient in Ozempic, is also licensed as a weight loss treatment under the brand Wegovy, however this product has not yet been rolled out in Ireland.
Novo Nordisk, the Danish pharmaceutical giant behind both drugs, has seen huge profits as a result of the large demand for the new medications.
A spokeswoman for the manufacturer said it was “experiencing stronger than anticipated demand” for Ozempic, resulting in periodic shortages.
“We are working tirelessly to maximise existing production while investing heavily in new capacity to remedy this shortfall,” she said.
The company has previously said it plans to make Wegovy available in the Republic as soon as possible.
However, in a May 18th email to the department, Mr Scully said he would caution against Wegovy being seen as a “panacea” to Ozempic supply pressures.
The HPRA official said the “simple market launch of Wegovy may not change demand for, by now, the well-recognised brand name Ozempic”.
