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Medsafe recalls for four products with undeclared prescription medicines

Acting Director-General of Health Andrew Bridgman today advised consumers to immediately stop taking four 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 - So Hard for Men, Pulse8 for Women, The Rock, and Tonic 66.

Investigations by Medsafe found that the products contained undeclared prescription medicines, namely tadalafil, sildenafil, and hydroxyhomosildenafil.

"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 four 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.

Product name	Undeclared medicine (dose)	Content
So Hard for Men	Tadalafil (21 mg)
Pulse8 for Women	Tadalafil (25 mg) Sildenafil and Tadalafil	Capsule contents Capsule shell
The Rock	Hydroxyhomosildenafil (530 mcg)	Capsule content and shell
Tonic 66	Tadalafil (10 mg)	Capsule shell

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 is a compound similar in structure to sildenafil. Its safety and efficacy have not been established.

"Since July 2009, Medsafe has identified 29 ostensibly herbal supplements to enhance sexual performance which have been adulterated with similar prescription medicines. The practice of adulterating this type of products with 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.

ENDS

Questions and Answers:

What is wrong with these products?

The products have been found to contain the undeclared therapeutic substances tadalafil, sildenafil and/or hydroxyhomosildenafil.

Tadalafil is the active ingredient in Cialis. Cialis is the only brand of tadalafil approved for sale in New Zealand and is used for treating erectile dysfunction. Sildenafil is the active ingredient in Viagra. Viagra is the only brand of sildenafil approved for sale in New Zealand.

Both tadalafil and sildenafil are known to interfere with some heart medications and could be fatal to some individuals. Products containing tadalafil, sildenafil, hydroxyhomosildenafil or other similar substances should only be used on the advice of an authorised New Zealand prescriber, after the benefits and risks of use have been assessed.

More information about medicines that interact with tadalafil and sildenafil, and other precautions relating to their use is available on the Consumer Medication Information on Medsafe's website, which can be accessed by typing Cialis or Viagra into the search engine at: www.medsafe.govt.nz.

Hydroxyhomosildenafil is a compound similar in structure to sildenafil. Its safety and efficacy have not been established as no products containing hydroxyhomosildenafil have been approved for sale in New Zealand.

The safety, quality and efficacy of the products in question are unknown as they have not been evaluated prior to their distribution 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. They are advised to seek medical advice from their doctor if they felt unwell when taking the products, or are taking other medicines.

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.
Have these products been removed from sale?

As soon as the results from the ESR testing were received, Medsafe contacted and visited the known distributors and retailers of these products. They were told to remove all stock from their shelves and quarantine it, as they coud not be sure about what these products contain. Furthermore, their sale may be in breach of the medicines legislation. They were also told to notify any other distributors that they might have sold these products to, and all mail order customers advising that the products were being recalled and all unused products should be returned.

Medsafe has been notified that some stock had already been returned, and this is expected to continue. Medsafe is continuing to investigate the matter and may take regulatory action if necessary.

Have the products on sale in New Zealand been tested?

Medsafe commissioned the Institute of Environmental Science and Research to test samples of the four products. The results of these tests are summarised in the following table:

Product name	Undeclared medicine (dose)	Content
So Hard for Men	Tadalafil (21 mg)	tablet
Pulse8 for Women	Tadalafil (25 mg) Sildenafil and Tadalafil	Capsule contents Capsule shell
The Rock	Hydroxyhomosildenafil (530 mcg)	Capsule content and shell
Tonic 66	Tadalafil (10 mg)	Capsule shell

Information from the manufacturers and suppliers about the content of erectile dysfunction products sold over-the-counter or on the Internet is likely to be inadequate. It would therefore be prudent not to rely on the labels or other promotional statements made about the ingredients in these products.

Where can I find more information about Cialis and Viagra and their active ingredients and side effects?

Consumers seeking general information about Cialis or Viagra and their active ingredients 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/Medicines/infoSearch.asp.
What about other similar products?

There are many products available from retailers and on the Internet that claim to improve sexual performance or treat erectile dysfunction. Because of the illicit international trade in some of these products, products that have not been approved for sale in New Zealand may contain potentially harmful substances. Previous investigations by Medsafe have identified a number of products adulterated with prescription medicines used to treat erectile dysfunction such as tadalafil and sildenafil.

The use of these products can lead to potentially serious consequences, including death. That is why Medsafe has warned against their use.
What is Medsafe's 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 legislation very seriously, especially where patient and consumer safety is put at risk. Regulatory action will be taken as necessary to ensure compliance.