Media release from Medsafe

Acting Director-General of Health Andrew Bridgman today advised consumers to immediately stop taking six products for erectile dysfunction or the enhancement of sexual performance which contain undeclared prescription medicines, citing significant health risks from their use.

The warning, issued under Section 98 of the Medicines Act 1981, followed Medsafe's order for the immediate recall of all batches of the following products - Shaguar, Signature Signergy, VIGRX (2 presentations), VigRx, and VigRX Plus. Photos of the recalled products will be published on the Ministry of Health website.

Investigations by Medsafe found that the products contained one or more undeclared prescription medicines, sildenafil, hydroxyhomosildenafil, thiosildenafil, and/or tadalafil.

"Consumers should immediately stop taking these products and seek medical advice if they have felt unwell when taking any of these products or if they are also taking other medicines," Mr Bridgman said.

The six products are being promoted and sold in New Zealand by various retailers, including "adult" shops, and over the Internet as products that could enhance sexual performance or treat erectile dysfunction.

The Institute of Environmental Science and Research tested samples of the products and found them to contain significant quantities of prescription medicines.

Tadalafil is the active ingredient of the prescription medicine Cialis, which is used to treat erectile dysfunction. Sildenafil is the active ingredient in the prescription medicine Viagra, which is also prescribed for erectile dysfunction. Both taladalafil and sildenafil are known to interfere with some heart medications. Their use can be harmful and even fatal for some people.

Hydroxyhomosildenafil and thiosildenafil are compounds similar in structure to sildenafil. Their safety and efficacy have not been established.

"Since July 2009, Medsafe has identified 45 ostensibly herbal supplements to enhance sexual performance which have been adulterated with similar prescription medicines. The practice of adulterating this type of product with prescription medicines is common," Mr Bridgman cited.

"I advise consumers to treat with extreme caution products purportedly for the treatment of erectile dysfunction or to improve sexual performance offered for sale without a prescription. They should seek medical advice before using them."

Sponsors, distributors, retailers and importers are responsible for the products they sell. They are required under the Medicines Act 1981 to be aware of all the active ingredients contained in their products and to seek approval prior to selling them.