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Revised: 17 April 2007

Health warning issued under Section 98 of the Medicines Act 1981 - Chinese medicines containing undeclared prescription medicines

Director-General of Health, Stephen McKernan, is warning people about the potential health dangers associated with 5 Chinese medicine products which have been found to contain undeclared prescription medicines for weight loss and erectile dysfunction.

This statement about the 5 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.

Testing of the products, apparently imported from Asia and being sold as Chinese medicines, found that each contained undeclared prescription medicines. These products have now been seized and removed from shelves, Stephen McKernan says.

One product, labelled Dai Dai Hua Jiao Nang, was found to contain the prescription medicine sibutramine, which is used for the treatment of some overweight (obese) patients. Sibutramine can cause increased blood pressure and heart rates and cannot be safely taken by a range of people, including those with glaucoma, mental illness and severe liver or kidney problems. It should not be used in combination with other medicines, such as some antidepressants and migraine treatments.

Testing of the four other Chinese medicine products showed they all contained sildenafil, a prescription medicine used to treat erectile dysfunction. These products were labelled "Darling Capsules"; "Dali Capsules"; "Spanish Fly Capsules"; and an unnamed product comprised orange capsules in plastic and silver foil blister packs.

Sildenafil is known to interfere with some heart medication and could be fatal to some individuals.

"Consumers should immediately stop taking these products and seek medical advice from their doctor if they are taking other medicines, have felt unwell when taking the products, or if they have become unwell after they stopped taking the products," Mr McKernan says.

Investigations into these products began following a complaint that a retail outlet had sold a product suspected of containing an undeclared prescription medicine.

The products appear to have been sold on request 'under-the-counter' and without any labelling or packaging indicating their ingredients or instructions for use. The investigations are continuing.

"Medsafe is actively investigating the sale and distribution of these types of products. Recently, the Ministry of Health has taken regulatory action against several individuals and companies found to be in breach of the law."

Under the medicines legislation, sponsors, distributors and importers are required to list all active ingredients on product packaging, and to include the strength of each active ingredient. Only approved prescription medicines can be sold to the public and then only under a prescription given by an authorised prescriber. It is also illegal for an individual to possess personal supplies of a prescription medicine without first having obtained a medical practitioner's prescription for them.

"We are concerned about the continuing numbers of Chinese-type medicines being found to contain undeclared prescription medicines," Mr McKernan says.

A similar warning about Dai Dai Hua Jiao Nang, which is also known as Li Da, was issued in March 2006.

Photographs of the products

ENDS

For further information please contact:

Lucy Taylor, Media Advisor, Ministry of Health
04 496 2349 / 027 687 5642


Questions and Answers

What is wrong with these products?

The products identified as containing undeclared prescription medicines are likely to have been supplied unlabelled. The products can be identified as follows:

Products found to contain sildenafil, a prescription medicine used to treat erectile dysfunction:

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 medication and could be fatal to some individuals. 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.

Dai Dai Hua Jiao Nang, was found to contain the prescription medicine sibutramine used for the treatment of some overweight (obese) patients. Reductil is the only brand of sibutramine approved for sale in New Zealand and is used for managing overweight (obese) patients who have not been able to lose weight using a low calorie diet and exercise.

Sibutramine can cause increased blood pressure and heart rate and cannot safely be taken by a range of people, including those with glaucoma, mental illness and severe liver or kidney problems. It should not be used in combination with other medicines such as some antidepressants and migraine treatments.

Have these products been removed from sale?

The distributor of these products has been required to immediately cease supplying them. Stocks have been seized.

The products appear to have originated from China or from a country where Chinese language is used to label medicinal products.

Medsafe investigations are continuing and prosecution is being considered in relation to the alleged distributor

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; have felt unwell when taking the products; or if they have become unwell after having stopped taking them.

There is no reliable information about how many people have taken these products.

Adverse reactions to these products or to any herbal product 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/safety/report-a-problem.asp

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

Consumers seeking general information about Viagra and Reductil and their active ingredients sildenafil and sibutramine 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

Important advice to traders

Under the food and medicine legislation, sponsors, distributors and importers are required to list all active ingredients on the packaging, and to include the strength of each active ingredient.

Distributors, importers and sellers are responsible for ensuring the products they import or sell do not contain any prescription medicines. It may, for instance, be prudent to test products prior to distribution. It is illegal to sell or supply prescription medicines without the purchaser having a prescription from a registered medical practitioner.

On conviction, the maximum penalty for an individual who sells a medicine without first having it registered 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 registered 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.

Photos of products containing sildenafil and sibutramine

Dai Dai Hua Jiao Nang in silver foil with blue and lavendar print
Dai Dai Hua Jiao Nang in silver foil with blue and lavender print

Darling Capsules in silver foil with green print
Darling Capsules in silver foil with green print

Dali Capsules in silver foil with green print
Dali Capsules in silver foil with green print

Spanish Fly Capsules in silver foil with green print
Spanish Fly Capsules in silver foil with green print

Unnamed orange capsules in plastic and silver foil blister with green print Unnamed orange capsules in plastic and silver foil blister with green print
Unnamed orange capsules in plastic and silver foil blister with green print

 

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