Safety Information

Consumers advised to stop taking adulterated products for erectile dysfunction

7 May 2010

Medsafe orders immediate recall of SZM Formula for Men, Stallion, Volcanic and Tomcat Ali

Director-General of Health Stephen McKernan today advised consumers to immediately stop taking the following adulterated products for erectile dysfunction - SZM Formula for Men, Stallion, Volcanic and Tomcat Ali, citing significant health risks from their use.

Medsafe has ordered the immediate recall of all batches of the four products after tests showed that they contain the undeclared prescription medicine tadalafil. Medsafe's investigations found the products were being sold by retail in health food stores and pharmacies as well as "adult" shops and over the Internet.

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

The four products are being promoted and sold in New Zealand for sexual enhancement or the treatment of erectile dysfunction. The Institute of Environmental Science and Research (ESR) has confirmed that samples of these products submitted by Medsafe contained significant quantities of tadalafil.

Tadalafil, which is the active ingredient of the prescription medicine Cialis, is known to interfere with some heart medications; its use can be harmful and even fatal for some people.

Mr McKernan said ESR's test results also indicated that rogue players behind these products now appear to be adopting a new approach in adulterating them. The adulterant in these products was added to the material of the capsule shell rather than to the contents, which are the components checked during routine screening by regulators.

The Director-General of Health further warned that the practice of adulterating capsule shells may not be confined to just these four products.

"This is a cautionary tale for consumers. I advise them to treat products purportedly for the treatment of erectile dysfunction and products that claim to improve male sexual performance that are offered for sale without a prescription with extreme caution, and to seek medical advice before using them."

The medicines legislation charges sponsors, distributors, retailers and importers with the responsibility for the products they sell and requires them to be aware of all the active ingredients they contain and to seek approval prior to selling them, if required by legislation.

ENDS

Questions and Answers

1. What is wrong with these products?

The products have been found to contain the undeclared therapeutic substance tadalafil. Tadalafil is the active ingredient in Cialis.

Cialis is the only brand of tadalafil approved for sale in New Zealand and is used for managing erectile dysfunction. Tadalafil is known to interfere with some heart medications and could be fatal to some individuals. Products containing tadalafil or other similar substances 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 tadalafil and other precautions relating to its use can be found by accessing the Consumer Medication Information on the Medsafe website by typing Cialis into the search engine at: www.medsafe.govt.nz/regulatory/DBSearch.asp.

The safety, quality and efficacy of the products in question is unknown as they have not been evaluated prior to their distribution in New Zealand through the medicines approval process.

2. 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.

Due to the way they are supplied, 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: https://nzphvc.otago.ac.nz/report/.

Consumers can also report any concerns to Medsafe: www.medsafe.govt.nz

3. 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 has asked the companies that are distributing these products to issue a recall notice to their retailers and any mail order customers. Medsafe has also asked the companies to place recall notices in national newspapers to alert consumers to the health risk. Medsafe is continuing to investigate the matter and may take regulatory action if necessary.

4. Have the products on sale in New Zealand been tested?

Medsafe had commissioned testing of the four products by ESR. The capsule contents and capsule shells were tested separately. The capsule contents were found to contain trace amounts of tadalafil, and the capsule shells were found to contain undeclared tadalafil in therapeutic doses. 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.

5. Where can I find more information about Cialis and its active ingredient and side effects?

Consumers seeking general information about Cialis and its active ingredient tadalafil 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/regulatory/DBSearch.asp

6. What about other similar products?

There are many products 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 some of 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 prescription medicines used to treat erectile disfunction, such as tadalafil.

The concern and risk of serious consequences (including death) is real enough for Medsafe to warn against taking any of these products.

7. 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.

For media queries, please contact: Luz Baguioro, Media Advisor (04 496 2349, 021 802 622)