Undeclared sildenafil at prescription strength has sparked a serious safety alert and a border crackdown.
The Therapeutic Goods Administration has sounded the alarm on Natures Valley Collagen Builder tablets saying it could cause serious side effects.
The warning comes after laboratory testing uncovered a high dose of undeclared sildenafil hidden in the product, exposing consumers to potentially dangerous cardiovascular risks, the regulator said in a statement.
The TGA said the tablets contained approximately 199.3mg of sildenafil per dose, an amount consistent with prescription-only erectile dysfunction medicines, despite no disclosure on the label and no approval for supply in Australia.
Sildenafil can cause profound hypotension, particularly when taken with nitrates or certain antihypertensive agents, placing patients with cardiovascular disease, diabetes, hyperlipidaemia or hypertension at elevated risk.
Without medical supervision, consumers may be unaware of contraindications, dose limits or potential interactions, increasing the likelihood of serious adverse events.
“The supply of Natures Valley Collagen Builder tablets containing undisclosed sildenafil is illegal,” the TGA said in a statement.
“Natures Valley Collagen Builder tablets have not been assessed by us for quality, safety or efficacy as required under Australian legislation.”
The warning included the following advice:
- Consumers were urged exercise extreme caution when buying medicines and medical devices online including through social media and other digital platforms;
- Australians currently using products, particularly if obtained from overseas or online, should refer to the multiple safety alerts and advisories issued by the TGA and speak with their health professional about the right option for their circumstance to ensure their safety.
The TGA has advised consumers to stop taking the tablets immediately and to dispose of remaining stock through a pharmacy.
The TGA’s chief medical officer Professor Robyn Langham urged people to “exercise extreme caution when buying medicines and medical devices online including through social media and other digital platforms”.
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“Australians currently using products, particularly prescription medicines obtained from overseas or online, should refer to the multiple safety alerts and advisories issued by the TGA and speak with their health professional about the right option for their circumstance to ensure their safety,” Professor Langham said.
The TGA is working with the Australian Border Force to intercept and destroy imported consignments.
Any suspected adverse reactions should be reported through the TGA’s adverse event reporting system to support ongoing surveillance and regulatory action.
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