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The Guardian - AU
The Guardian - AU
National
Alyx Gorman

TGA issues safety alerts after online herbal supplements found to contain Viagra

Natural vitamin supplements on a white flat surface
Australia’s pharmaceutical watchdog has issued safety alerts for online herbal supplements, after testing found they contained sildenafil (known as Viagra) and tadalafil (Cialis). Photograph: Eyecrave Productions/Getty Images

Australians seeking to enhance their sexual performance using online herbal supplements could be getting more than they bargained for – and risking their health in the process.

On 29 January, Australia’s pharmaceutical watchdog, the TGA, issued safety alerts for seven supplements, including Tantra Jelly, Bullblood tablets and Throb herbal supplements after testing found they contained sildenafil, tadalafil and in some instances both.

These substances, better known by their brand names Viagra (sildenafil) and Cialis (tadalafil), are prescription-only products in Australia and can have a host of side effects, and serious interactions with other medications.

In a statement to Guardian Australia, the TGA said: “The products were not marketed to consumers as containing the schedule 4 substances sildenafil, tadalafil or vardenafil which was the reason for the publication of the safety alerts.”

The TGA stated the products “were located during an ongoing investigation”, and that the products were seized as “potentially counterfeit”, which it said in the warnings was confirmed by subsequent laboratory testing. When asked where the products were sourced from, the TGA stated: “As this is an on-ongoing investigation, no further details on this specific matter can be provided at this stage.”

In their safety alerts, the TGA warned consumers “to exercise extreme caution when purchasing medicines from unknown overseas websites”.

They stated that products bought online “may contain undisclosed and potentially harmful ingredients” and that they “may not meet the same standards of quality, safety and efficacy as those approved by us for supply in Australia”.

In a statement to Guardian Australia, the TGA strongly discouraged consumers from self-medicating with ED medicines.

“ED products that claim to be herbal, natural or energy supplements are not necessarily safe,” they said. “The TGA warns consumers that ED products sold online, especially from sellers that do not request a valid doctor’s prescription, may be counterfeit. These products may contain undeclared (hidden) substances that could cause a serious adverse reaction.”

Prof Steve Robson, president of the Australian Medical Association said: “People need to be extremely careful if they are sourcing herbal supplements, because some are potentially harmful and it’s very difficult to be certain about what they contain.”

In a statement to Guardian Australia, Robson said that supplements bought online from international websites pose particular risks. He said Australians should use only local pharmacies when buying medication online.

“While evidence-based complementary medicine can play a role in patient care under the guidance of a doctor, there is limited evidence on the effectiveness of most complementary medicines, and some have the potential to cause adverse reactions or interact with conventional medicines,” Robson said.

“Unproven complementary medicines and therapies can also pose a risk to patient health either directly through misuse or indirectly if a patient defers seeking medical advice.

“There’s also the risk of people spending money on unproven medicines and therapies.”

A 2020 review published in the medical journal Drug Testing and Analysis found that “there is a growing trend toward the intentional adulteration of dietary supplements (DS) with synthetic pharmaceuticals, which represents an alarming emerging risk to consumers and a serious problem for regulatory agencies”.

The review found that between 2010 and 2019, 44.7% of reported adulterants were found in erectile dysfunction supplements, and 81% of these adulterated sexual enhancement supplements contained sildenafil or one of it’s analogues.

The TGA has urged anyone who bought Bullblood tablets, Kamasutra herbal jelly for him, Commander Stamina Time tablets, Excite for her tablets or Throb Herbal supplement tablets to stop using the products. They told consumers to take any remaining product to their local pharmacy for safe disposal, and to contact a medical professional with any health concerns.

The TGA also stated that: “Ongoing enforcement activities conducted by the TGA have resulted in the seizure of products containing scheduled substances from brick-and-mortar retail outlets.”

“The TGA has previously issued infringement notices totalling $53,280 to Brisbane-based company Performance Online Services Pty Ltd for the alleged export, supply and advertising of counterfeit erectile dysfunction (ED) medicines in breach of the Act.”

The TGA said that consumers should check to ensure any supplement or medicine they purchase is listed on the Australian register of therapeutic goods (ARTG). “Manufacturers of products on the ARTG, whether overseas or onshore, hold the required manufacturing licences and/or certifications to manufacture therapeutic goods to an acceptable Australian standard.”

“Products not on the ARTG may contain undisclosed and potentially harmful ingredients,” they said. Such products also “may not meet the same standards of quality, safety, and efficacy as those approved by us for supply in Australia”.

Consumers have been advised to report concerning side-effects from any medication or herbal supplement to the TGA online, or by calling 1800 020 653.

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