Big Penis USA tablets have been reviewed by the TGA

Big Penis USA tablets pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled Big Penis USA tablets and found that:

• the tablets contain the undeclared substance sildenafil
• Sildenafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates.
• Sildenafil taken in combination with other medications can cause serious side effects.

Consumers are advised that sildenafil is a prescription-only substance in Australia.

The supply of Big Penis USA tablets containing undisclosed sildenafil is illegal.

Big Penis USA tablets have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Information for consumers

• Stop using Big Penis USA tablets and take any remaining tablets to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.
• If you suspect you have had a side effect (also known as an adverse event) to this product, please report it to the TGA. In addition, if you have concerns about this or other products, you can make a report to the TGA on 1800 020 653 or through our website.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments of Big Penis USA tablets from entering Australia.

The TGA will notify ABF to seize and destroy any of these products intercepted at the border.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites and has produced a short video on the risks associated with buying medicines and medical devices online.  

Products purchased over the Internet:

• may contain undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Phone: 1800 020 653

Online: Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products

Email: info@tga.gov.au