Fresh warning for ‘Barbie drug’

6 minute read

Dermatologists are worried about the popularity of melanotan-II, which promises a rapid tan without the need for sun exposure.

Social media influencers and suppliers are finding ways around legislation banning advertising of melanotan-II – dubbed the “Barbie drug”, say Australian dermatologists.

And they have issued warnings about the use of the unapproved drug, which promises a rapid tan without the need for extended sun exposure.

Liverpool Hospital dermatologist, Associate Professor Deshan Sebaratnam, said melanoma was a major worry, not to mention the fact the drug was illegal to advertise and supply in Australia.

“By increasing the activity of melanocytes, the main concern is that it may promote development of melanoma,” he told The Medical Republic.

“Other reported side effects include changes to freckles and moles, flushing, nausea and vomiting, priapism and spontaneous yawning.”

Melanotan-II is a synthetic version of ?-melanocyte-stimulating-hormone, which is produced in the pituitary gland of the brain and is naturally present in the body. The hormone acts on specialised skin cells responsible for producing pigment.

“In our skin, we have pigment cells and we have hormones that regulate the activity of those pigment cells,” Professor Sebaratnam explained.

“So what melanotan-II does is mimic the action of those hormones and upregulate the activity of our pigment cells.”

Professor Sebaratnam, who is also conjoint associate professor at UNSW, said the drug had become popular on social media.

“Patients can buy it online but not from legitimate sources,” he told TMR.

“It’s illegal to advertise melanotan to the public or supply it without a prescription. I think it’s important that if patients present interested or having used melanotan, their primary care provider discourage it, discuss the unregulated nature of the product and highlight the untested nature of this drug.”

Late last year the TGA issued a statement urging consumers to steer clear of products containing melanotan without the advice of a medical professional.

“Melanotan-I and (especially) melanotan-II are typically promoted as tanning products and may be in the form of pills, creams, injectable and nasal or misting sprays,” the statement said. “Regardless of the how the product enters the body, the associated risks remain, and are not new.”

Melanotan-II is not included on the Australian Register of Therapeutic Goods (ARTG) and it has not been assessed for quality, safety or efficacy by the TGA. Its development as a potential medicine was halted some years ago due to safety reasons, according to the TGA statement.

And while melanotan-I (afamelanotide) is approved as a prescription medicine to support the management of the rare genetic disease erythropoietic protoporphyria, its side effects and highly specialised role means it should only prescribed and used under close medical supervision.

“This makes it illegal to advertise either melanotan-I or II to the general public, and illegal to supply them without a doctors’ prescription,” the TGA states.

“If advertising is found to contravene the Act, penalties including criminal and civil sanctions may apply irrespective of disclaimers.”

The TGA said it was working with social media and digital platforms to address unlawful promotion of melanotan-II.

Following the TGA warning last year, TikTok released a statement saying videos relating to the promotion or sale of nasal tanning sprays and melanotan “were in clear breach of our Community Guidelines and have been removed from our platform”.

“In addition, we have also banned hashtags including #tanningnasalspray #melanotan and #melanotan2,” the statement said.

Yet videos featuring melanotan-II continue to appear, with measures taken to avoid the restrictions such as using generic hashtags like #tanning.

Dr John Frew, a dermatologist at Liverpool Hospital and conjoint senior lecturer at UNSW Medicine and Health, said questions remained about how to protect social media users from the advertising of illegal and harmful products, and the responsibilities of social platforms.

“The reach of the TGA is obviously quite limited in terms of what happens on TikTok and Instagram. That’s a big problem with no clear solution,” he said.

He echoed Professor Sebaratnam’s concerns about the drug.

“You’re stimulating pigment cells with melanotan-II. If you do that enough, you can cause abnormal proliferation of the cells,” said Dr Frew.

“And this can jumpstart the progression to the possible development of melanoma.”

Videos featuring melanotan-II continue to appear, with measures taken to avoid the restrictions such as using generic hashtags like #tanning. A TMR search of melanotan-II on Google found sites offering melanotan-II injections and nasal sprays for “next day delivery” in Australia.

One of the sites, Melanotan II Australia, offered the products in kits starting at $95. Concerningly, in its FAQ section it downplays the drug’s possible side effects.

“The most common side effect of melanotan II is appetite suppression, but it should not be as significant as one might associate with diet or fat loss medications,” the site says. 

“Nausea and fatigue or a lightheaded feeling can also be somewhat common in some individuals. Such effects may be strong but should clear quickly. Dosing may need to be reduced should such effects occur until a more comfortable level is reached.

“Melanotan II can also cause darkening of hair, although not significantly. It may also include the darkening of moles, and in some cases, may be cause to discontinue use. Darkening of moles is the one side effect of melanotan II an individual would want to keep a close eye on.” 

TMR approached the company for comment but has not received a response.

A screenshot of Melanotan-II Australia’s website offerings. Picture:

Professor Sebaratnam said he “wouldn’t go near it” and he had seen the side effects of this drug firsthand.

“I’ve had one patient who presented looking the colour of brown glass but was quite happy with their appearance,” he said.

And when he tried to raise concerns with the patient, he said they “didn’t want to listen to anything I said”. 

Environmental carcinogenesis expert, Professor Bernard Stewart, said previous case reports had recorded complications like melanoma, although the evidence was still limited.

“Case reports have described melanomas emerging from existing moles either during or shortly after the use of melanotan-II,” he said

“However, evidence for causal associations is lacking … definitive proof is yet to be established.”

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