Federal Ban on Ozempic Replicas

ozempic replica ban

Federal Government to Ban Compounded Replica Ozempic Amid Safety Concerns

The federal government will prohibit all compounding pharmacists from producing replica versions of diabetes drugs like Ozempic and Mounjaro, widely used off-label for weight loss, following a Four Corners investigation that exposed illegal manufacturing practices in Australia.

Investigation Findings

A video recorded by investigators from the Therapeutic Goods Authority (TGA) revealed that a facility in Western Sydney was producing these drugs under unsanitary conditions, using kitchen equipment and chemicals. The investigation found that these illegally manufactured drugs were being exported overseas.

Ongoing Drug Shortages

Global shortages of Ozempic are expected to continue into next year. The government has announced a four-month transition period for the industry before the ban takes effect.

Public Safety Concerns

The Four Corners investigation uncovered that a registered Australian pharmacist was running an international operation, manufacturing and exporting replica Ozempic to the United States. Patients who used medication from Total Compounding Pharmaceuticals (TCP) reported serious side effects, including nerve damage, rashes, vomiting blood, and bleeding gums, which they believe were linked to the compounded drugs.

Currently, Australian compounding pharmacists are allowed to reproduce brand-name drugs during shortages, but these replicas are not subjected to the same stringent safety checks. Federal health minister Mark Butler announced that this loophole will close in October, removing the exemption for compounding active ingredients in drugs like Ozempic.

Impact on Patients and the Industry

In Australia, an estimated 20,000 people use compounded weight loss medications, but the actual number may be higher. The TGA has already seized vials of unlawfully manufactured semaglutide from a Victorian pharmacy.

Minister Butler expressed concern that many patients using compounded versions of these drugs were unaware of the safety risks, which have also been highlighted by the FDA in the United States. He emphasized the lack of oversight in the manufacturing conditions and the ingredients used, as well as the absence of a formal system for reporting adverse events.

Filthy Manufacturing Conditions

The TGA provided footage showing the deplorable conditions in which TCP was allegedly producing replica Ozempic. The facility, filled with kitchen mixers and blenders, did not meet the standards expected for manufacturing injectable medications.

Regulatory and Industry Response

The announcement of the ban has garnered support from various health organizations, including the Pharmacy Board of Australia, Diabetes Australia, the Medical Board of Australia, and the RACGP. However, some pharmacy groups and telehealth companies, like Eucalyptus, opposed the ban, arguing it would deny thousands of Australians access to life-changing medication amid global shortages.

Addressing the Shortage

RACGP president Dr. Nicole Higgins acknowledged the shortage and the potential anxiety it might cause for patients using Ozempic off-label for weight loss. Minister Butler assured that the government is working with pharmaceutical companies to mitigate the impact of the ban. He stressed the importance of prioritizing diabetes patients for whom these drugs are approved under the PBS.

“We’ve already got a shortage of this medication for the people it was initially designed for, which is our [people with] type 2 diabetes. I expect that those shortages may be exacerbated, and it’s going to cause some anxiety for those who’ve been using Ozempic off-label,” Dr. Higgins said.

The TGA’s latest update indicates that the supply of Ozempic will remain limited throughout 2024 due to increased demand for weight loss, with Mounjaro also expected to be in short supply until at least September.

Moving Forward

Patients relying on compounded medications are advised to consult their GPs and healthcare teams for support during this transition. Minister Butler reiterated the government’s commitment to ensuring that diabetes patients have priority access to these essential medications.

The four-month transition period is intended to allow the industry to adapt while safeguarding public health by eliminating unsafe manufacturing practices.

Ozempic and Alcohol

ozempic and alcohol study3

Novo Nordisk to Investigate Ozempic’s Impact on Alcohol Consumption

Study Announcement

Novo Nordisk, the manufacturer of Ozempic, has announced plans to investigate the drug’s potential to reduce a user’s desire to consume alcohol. The company revealed a 28-week study aimed at evaluating the impact of semaglutide, the active component in Ozempic and other medications, on alcohol intake.

Focus on Liver Health

In a statement to CNN, Novo Nordisk mentioned that the upcoming trial will focus on whether the drug can enhance liver health by addressing liver fibrosis or scarring, rather than targeting alcohol addiction specifically.

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A person on a scale Related: Ozempic May ‘Potentially’ Influence Your Personality — and Sex Life, Expert Says

Trial Details on Ozempic & Alcohol

A Novo Nordisk spokesperson told the outlet, “Secondary endpoints include safety and tolerability and changes in alcohol consumption. There is a significant unmet medical need in alcohol-related liver disease, and the first line of treatment for this condition is lifestyle intervention to refrain from drinking alcohol.”

They added, “Even though not all participants in the trial will have alcohol use disorder, it is natural to include alcohol consumption as a secondary endpoint.”

The trial plans to recruit 240 participants and is set to commence on Monday, May 20, as per a government database, CNN reported.

A set of semaglutide injection pens

Clinical Observations

Ania Jastreboff, M.D., PhD., an obesity medicine physician scientist at Yale University, shared with PEOPLE last year that some patients using Ozempic report a diminished craving for alcohol.

“Clinically, I’ve seen this. Some patients say they have less desire to drink alcohol. For instance, they used to drink a couple of glasses of wine, now they only drink half a glass and don’t feel the urge to finish it,” she said.

“It seems they achieve the reward or satisfaction from a smaller amount or just don’t feel like having a glass of wine,” Jastreboff added.

A woman injecting a weight loss pen into her stomach (stock image) Related: Celebrities Who’ve Talked About Ozempic — and What They’ve Said

Expert Insights

Dr. Steven Batash, a board-certified gastroenterologist and weight-loss specialist at Batash Endoscopic Weight Loss, told PEOPLE in April that weight-loss medications can also affect libido and potentially alter personality.

“GLP-1s specifically reduce the amount of dopamine the brain releases after engaging in activities like drinking, smoking, or eating a sweet dessert,” he explained.

“Dopamine is a neurotransmitter that reinforces the pleasure of these activities. When GLP-1s remove that pleasure, they also reduce the motivation to partake in these activities,” Batash added.