'Big Penis USA' pills banned in Australia for containing hidden drug ingredient

Jan 25, 2024

The Therapeutic Goods Administration (TGA) released a public service announcement, cautioning men to avoid taking the pill.

Health officials in Australia have issued a public warning advising men to avoid "Big Penis USA" pills after discovering they contained sildenafil — the erectile dysfunction medication sold under the brand name Viagra.

The Therapeutic Goods Administration (TGA) released a public service announcement, cautioning men to avoid taking the pill.

"Big Penis USA tablets pose a serious risk to your health and should not be taken," the TGA said.

"The tablets contain the undeclared substance sildenafil. It may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels," it added, declaring the supply of the pill as illegal.

Sildenafil is a prescription-only drug, used to treat erectile dysfunction. If combined with certain prescription medicines, the dosage can be potentially fatal, the public health watchdog said.

The TGA has joined forces with the Australian Border Force (ABF) to stop future shipments of Big Penis USA tables from entering the Down Under country.

"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."

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Notably, the pill is not sold in Australian stores. However, owing to its wild internet popularity, Australian men had been purchasing the product online.

"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."

The ABF will be seizing and destroying any Big Penis USA products that are intercepted at the border.

Previously, the US Federal Drug Administration had also issued a similar warning advisory about the Big Penis USA pills for the exact same reason. After examining the international mail shipments of the product, FDA found high, undisclosed amount of sildenafil in the pills.

"The Food and Drug Administration (FDA) is advising consumers not to purchase or use Big Penis Male Sexual Stimulant, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments," the health watchdog said in 2016.

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"Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program," it added.

(With inputs from agencies)

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