Health warning issued under Section 98 of the Medicines Act 1981

Director-General of Health, Stephen McKernan, is warning people about the potential health dangers associated with three products promoted and sold in New Zealand for sexual enhancement or the treatment of erectile dysfunction which may contain an undeclared therapeutic substance.

This statement about the three products is being issued by the Director-General under Section 98 of the Medicines Act 1981, following investigations by the Ministry of Health's medicines safety arm, Medsafe.

The products are Rize 2 the Occasion (also known as Rize 2), Rose 4 Her and Viapro. The products appear to have been sold by retail from ‘adult’ shops and over the internet.

The United States FDA has issued a warning that products on the US market with these names had been tested and recalled after they were found to contain the substance thiomethisosildenafil which is an analogue of sildenafil. Thiomethisosildenafil is expected to have similar therapeutic actions and adverse effects as sildenafil the active ingredient of the prescription medicine Viagra. Sildenafil is known to interfere with some heart medications and its use could be fatal to some individuals.

"Consumers should immediately stop taking Rize 2 the Occasion, Rose 4 Her and Viapro and seek medical advice from their doctor if they are taking other medicines or if they have felt unwell when taking any of these products," said Mr McKernan.

Stephen McKernan also warned that Medsafe has previously identified a number of other products being sold in shops and over the internet to treat erectile dysfunction or for sexual enhancement that have also been adulterated with prescription medicines. Consumers should treat erectile dysfunction products offered for sale without a prescription with caution and seek medical advice before using them.

Under the medicines legislation, sponsors, distributors and importers are responsible for the products they sell and must be aware of all the active ingredients they contain and seek approval prior to selling them if required by the legislation.