TGA Warns Multiple Sexual Enhancement Supplements Contain Hidden Prescription Drugs
Key Insights
The TGA issued safety alerts after laboratory testing found 11 sexual enhancement products contained undeclared sildenafil, tadalafil, and dapoxetine, all prescription-only medicines in Australia.
A separate investigation identified Grakcu capsules containing both sildenafil and tadalafil, raising heightened concerns about adverse effects from combined PDE5 inhibitor exposure.
Counterfeit honey sachets marketed for sexual enhancement, including Black Horse Honey and Royal Honey VIP, were also found to contain undeclared tadalafil.
The Therapeutic Goods Administration (search) (TGA) has issued a series of safety alerts warning that multiple sexual enhancement products marketed as natural or herbal supplements contain undeclared prescription-only medicines, exposing consumers to potentially serious adverse effects and dangerous drug interactions.
The regulator's laboratory testing identified hidden sildenafil (commonly marketed as Viagra), tadalafil (known by the brand name Cialis), and dapoxetine across a range of products promoted as dietary or natural formulations. None of these active pharmaceutical ingredients were declared on product labels.
"The TGA tested 11 products that claimed to be dietary or natural formulas, and found they contained undeclared prescription drugs," the regulator stated. The affected products include 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.
Grakcu capsules and combined PDE5 inhibitor risk
In a separate investigation, laboratory testing of Grakcu capsules identified both undeclared sildenafil and tadalafil. The TGA warned that the combination of two phosphodiesterase type 5 (PDE5) 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."
The regulator confirmed that Grakcu capsules have not been assessed for quality, safety, or efficacy, and that importing products containing undisclosed prescription medicines is illegal under Australian therapeutic goods legislation.
Counterfeit honey sachets
A third alert addressed what the TGA described as "counterfeit 'honey' sachets for sexual enhancement." Testing of imported unapproved products found undeclared tadalafil in 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 stated.
The regulator specifically highlighted that 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.
Clinical risks and vulnerable populations
Sildenafil and tadalafil work by relaxing blood vessels and increasing blood flow to specific areas of the body. While sildenafil is indicated for erectile dysfunction (search) and pulmonary arterial hypertension (search), these drugs can have serious side effects if taken without medical supervision.
Australian Medical Association president Dr Danielle McMullen told the ABC: "You never really know what you're going to get when buying the medicines online without a prescription. It really can put your health at risk."
Side effects can include dizziness, severe headaches, or more serious symptoms including chest pain, hearing loss, seizures, or altered vision. 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 PDE5 inhibitors are used.
Dapoxetine, also detected in some products, is a prescription medicine used for premature ejaculation in some countries but is not approved for general supply in Australia. Its undisclosed presence creates additional concerns about adverse effects and interactions with antidepressants and other serotonergic medicines, the TGA said.
Regulatory response and professional guidance
The TGA is working with the Australian Border Force to help prevent further importation of Grakcu capsules and other unapproved therapeutic goods containing undisclosed prescription medicines. The regulator emphasised that none of the products have been evaluated for quality, safety, or efficacy under Australia's therapeutic goods regulatory framework, and that some may be counterfeit or manufactured under poor-quality conditions.
For health professionals, the TGA said the alerts highlight 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.
"It can seem embarrassing to talk about sexual dysfunction, but for men's health, there are a lot of underlying health conditions that can present as difficulties in the bedroom," Dr McMullen said. "So it is important to chat to your GP to make sure you're getting the best possible healthcare. It's not worth messing around with your health."
The TGA urged 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. Healthcare professionals and consumers are encouraged to report suspected adverse events through the TGA's adverse event reporting system.