The TGA has warned that sexual enhancement products, including Grakcu capsules, contain undeclared prescription medicines that could cause serious adverse effects and dangerous drug interactions.
The Therapeutic Goods Administration has warned that multiple sexual enhancement products, including Grakcu capsules, contain undeclared prescription medicines that could cause serious harm.
The regulator has issued three separate safety alerts after laboratory testing found a range of products marketed as natural or herbal sexual enhancement supplements contained prescription-only medicines that were not declared on their labels, exposing consumers to potentially serious adverse effects and drug interactions.
The first alert covers 11 products sold as sexual enhancement supplements, while the second relates specifically to Grakcu capsules. Together, the alerts reinforce growing concerns about unapproved therapeutic goods sold online and through retail outlets that contain hidden active pharmaceutical ingredients.
The TGA laboratory tested the products promoted as dietary or natural formulations and found they contained undeclared sildenafil, tadalafil or dapoxetine. The affected products are Nano Volume capsules, Lustra 80 tablets, Candy Power For Man lozenges, Kama Exstasy200 tablets, Kama Super Platinum tablets, Nano Epigen Size capsules, Rock II Hard tablets, Cobra Max capsules, Black Bull Extreme cream, Gold Lion tablets and Black Cat capsules.
In a separate investigation, laboratory testing of Grakcu capsules identified undeclared sildenafil and tadalafil. The regulator warned that the combination of two phosphodiesterase type 5 inhibitors could further increase the risk of adverse effects, particularly in people with underlying cardiovascular disease or those taking interacting medicines.
“Consumers may not realise they are taking prescription medicines as sildenafil and tadalafil are not declared on the product label,” the TGA said.
“This increases the chance of dangerous drug interactions, contraindications and unexpected side effects.
“Grakcu capsules have not been assessed by the TGA for quality, safety or efficacy. Importing products that contain undisclosed sildenafil and tadalafil, such as Grakcu capsules, is illegal under Australian therapeutic goods legislation.”
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The third alert issued on Wednesday this week related to what the TGA described as “counterfeit ‘honey’ sachets for sexual enhancement”.
The TGA tested the following imported unapproved products and found that they contain undeclared tadalafil: Black Horse Honey sachets; Royal Honey VIP sachets; Vital Honey sachets; Helmi’s Honey sachets; and Etumax Royal Honey sachets.
“Tadalafil is regulated as a prescription-only medicine in Australia and should only be used under medical supervision. Tadalafil taken alone or in combination with other medicines can cause serious side effects,” the TGA said in a statement.
“Tadalafil may interact with nitrates found in some prescription medicines and may lower blood pressure to dangerous levels. Nitrates are often prescribed for people with diabetes, high blood pressure, high cholesterol or heart disease.
“The products tested by the TGA are considered counterfeit under the Therapeutic Goods Act 1989.”
For health professionals, the TGA said the alerts highlighted the importance of asking patients about their use of complementary medicines, imported supplements and products purchased online when assessing unexplained symptoms or adverse drug reactions.
Sildenafil and tadalafil are prescription-only medicines in Australia indicated for erectile dysfunction and, in the case of sildenafil, pulmonary arterial hypertension.
Patients with diabetes, hypertension, hypercholesterolaemia or established cardiovascular disease may be at particular risk because they are more likely to be prescribed nitrate therapy or other cardiovascular medicines that require careful assessment before phosphodiesterase type 5 inhibitors are used.
Dapoxetine, which was also detected in some of the products, is a prescription medicine used for premature ejaculation in some countries but is not approved for general supply in Australia.
Its undisclosed presence created additional concerns about adverse effects and interactions with antidepressants and other serotonergic medicines, the TGA said.
The TGA emphasised that none of the products have been evaluated for quality, safety or efficacy under Australia’s therapeutic goods regulatory framework.
The regulator also warned that some products may be counterfeit or manufactured under poor-quality conditions, creating additional risks beyond the undeclared active ingredients. Medicines purchased through overseas websites, online marketplaces or social media platforms may not meet Australian standards for safety, quality or efficacy even if they appear professionally packaged.
The TGA said it is working with the Australian Border Force to help prevent further importation of Grakcu capsules and other unapproved therapeutic goods that contain undisclosed prescription medicines.
It also encouraged health professionals to remind patients that erectile dysfunction could be a symptom of underlying cardiovascular disease, diabetes or other chronic health conditions that warranted medical assessment rather than self-treatment with unapproved supplements.
The TGA urged healthcare professionals and consumers to report suspected adverse events associated with these or other unapproved therapeutic goods through its adverse event reporting system to support ongoing safety monitoring and regulatory action.
The TGA also advised consumers to stop using all affected products immediately and take any remaining capsules, tablets, lozenges or creams to their local pharmacy for safe disposal.
Patients who have experienced adverse effects or who have concerns about previous use should seek medical advice.
