Media Releases
Health warning - Erectile dysfunction / sexual enhancement 'herbal' products
8 August 2008
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.
ENDS
For further information please contact:
Michael Flyger, Media Advisor, Ministry of Health ph 04 496 2265 or 027 474
6878
Questions and Answers
What is wrong with these products?
The products may contain an undeclared therapeutic substance which is expected to be similar in effect and in its adverse reactions to sildenafil. Sildenafil is the active ingredient in Viagra.
Viagra is the only brand of sildenafil approved for sale in New Zealand and is used for managing erectile dysfunction. Sildenafil is known to interfere with some heart medications and could be fatal to some individuals. Products containing substances similar to sildenafil should only be used on the advice of an authorized New Zealand prescriber after the benefits and risks of use have been assessed. More information about medicines that interact with sildenafil and other precautions relating to its use can be found by accessing the Consumer Medication Information on the Medsafe website by typing Viagra into the search engine at: www.medsafe.govt.nz/search.
The safety, quality and efficacy of the products in question is unknown as they have not been assessed for supply in New Zealand through the medicines approval process.
If a consumer is taking one of these products what should they do?
Consumers are being warned to immediately stop taking these products and seek medical advice from their doctor if they are taking other medicines or have felt unwell when taking the products.
There is no reliable information about how many people have taken these products.
Adverse reactions to these products should be reported to the Centre for Adverse Reactions Monitoring: www.carm.otago.ac.nz
Consumers can also report any concerns to Medsafe: www.medsafe.govt.nz
Have these products been removed from sale?
Distributors and retailers are warned that they should cease selling these products as they cannot be sure about what they contain and their sale may be in breach of the medicines legislation. Medsafe is contacting ‘adult’ shops and websites requiring the removal of these products from sale and providing general information about responsibilities retailers have under the legislation with respect to selling these types of products.
Medsafe is continuing to investigate the matter and may take regulatory action if necessary.
Have the products on sale in New Zealand been tested?
It is not currently possible to test for thiomethisosildenafil in New Zealand. Thiomethisosildenafil is a newly detected adulterant being added to supplements promoted for the treatment of erectile dysfunction and for sexual enhancement purposes. Information from the manufacturers and suppliers about the content of erectile dysfunction products sold over-the-counter or by internet is likely to be inadequate so it is not possible to rely on the labels or other statements made about the ingredients in these products.
Where can I find more information about Viagra and its active ingredient and side effects?
Consumers seeking general information about Viagra and its active ingredient sildenafil can access the Consumer Medication information on the Medsafe website by typing the trade name of the product into the search engine at: www.medsafe.govt.nz/search
What about other similar products?
Many products appear to be available from retailers and over the internet claiming to be for sexual enhancement, to improve sexual performance or for the treatment of erectile dysfunction. Because of the illicit international trade in these products it is not possible for anyone to be certain about the contents of any of the unapproved products on sale in New Zealand. Previous investigations by Medsafe have identified a number of products adulterated with medicines such as sildenafil.
The concern and risk of serious consequences (including death) is real enough for Medsafe to warn against taking any of these products.
Important advice to traders
Under the medicines legislation, sponsors, distributors and importers are required to obtain approval before they sell or distribute products intended for a therapeutic purpose.
Section 20 of the Medicines Act 1981 requires medicines to be approved before distribution in New Zealand. A breach of this requirement carries substantial penalties.
On conviction, the maximum penalty for an individual who sells a medicine without first having it approved through the regulatory process administered by Medsafe is $20,000 or up to 6 months in prison.
On conviction, the maximum penalty for a body corporate which sells a medicine without first having it approved through the regulatory process administered by Medsafe is $100,000.
The Ministry of Health takes breaches of the medicines laws very seriously, especially where patient and consumer safety is put at risk, and regulatory action will be taken as necessary to ensure compliance.
Links to FDA warnings
- http://www.fda.gov/oc/po/firmrecalls/devine07_08.html
- http://www.fda.gov/oc/po/firmrecalls/eglabs07_08.html
Link to Health Canada warning