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Traditional Chinese Medical Ltd Prosecuted

Prosecution of South Auckland Traditional Chinese Medical Ltd,

Media Release

9 May 2008

Medsafe prosecutes South Auckland Traditional Chinese Medical Ltd

The Ministry of Health's medicines and medical devices regulator Medsafe is pleased with the result of a prosecution brought against South Auckland Traditional Chinese Medical Ltd and its directors.

The defendants, David Wang, Helen Zhang and their company, were fined a total of $45,000 plus costs in the Manukau District Court on 4 April having pleaded guilty in September last year to various charges under the Medicines Act 1981. The charges were laid after a Ministry investigator noticed a sign at the South Auckland Chinese Medical Centre in Otahuhu, Auckland advertising "Natural Viagra", in February 2006. A purchase of the "Natural Viagra" was made and the finding that it contained an undeclared prescription medicine resulted in an investigation. Several unapproved medicines were found, including products containing undeclared prescription medicines tadalafil, sildenafil and sibutramine. Cialis is the only product containing tadalafil that is approved for distribution in New Zealand, Viagra is the only approved product containing sildenafil for use in erectile dysfunction and Reductil is the only approved product containing sibutramine. Several products indicated for a variety of conditions containing prescription medicines used for the treatment of asthma, glaucoma and eye infections were also seized. "This result sends a strong message to those trying to import or sell products containing prescription medicines without a legal right to do so, therefore putting public safety at risk," said Derek Fitzgerald, Medsafe Team Leader, Compliance. "This case demonstrates that consumers simply can't be assured about the safety or quality of the "natural" health product they are purchasing." He says the defendants were claiming to sell a "natural" medicine which includes a perception that the product is safe, when in fact they were selling a prescription medicine which had the potential to cause serious harm.

"It's vital we send signals to the community of retailers selling natural medicines that they risk prosecution if they sell products containing pharmaceuticals and the onus is on them to make sure the products they sell comply with the law."

"Medsafe has increased its surveillance at the border to decrease the importation of unapproved medicines, and will take steps to prosecute companies and individuals selling products that contain pharmaceuticals where these products have been imported and / or distributed illegally", said Derek Fitzgerald.

Background and drug information

During its investigation Medsafe seized several products from the premises of South Auckland Traditional Chinese Medical Ltd, and found that they contained prescription medicines. Two contained the substance sildenafil - the active ingredient present in Viagra to treat erectile dysfunction, one contained tadalafil, the active ingredient present in Cialis to treat erectile dysfunction and one other contained sibutramine, the active ingredient in Reductil, a medicine used to treat obesity.

Sildenafil has known serious risks which affect the circulatory system. Its use is contraindicated in patients with certain cardiac conditions. Information available on the Medsafe website indicates that patients should not take Viagra in certain circumstances, including the following situations: (a) when being treated with a certain group of medicines (nitrates) for angina or other heart conditions; (b) when sexual intercourse would be inadvisable due to heart or blood vessel problems; (c) following a stroke or heart attack in the previous six months; and (d) when suffering from severe liver problems and (e) when blood pressure is unusually high or low and not effectively treated.

Tadalafil is also contraindicated in patients with certain cardiac conditions.

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.

The charges involved: advertising the availability of an unapproved medicine; selling an unapproved medicine; sale of prescription medicines otherwise than by a pharmacist in a pharmacy and the possession of prescription medicines without reasonable excuse.

In October 2007, another Chinese medicine retailer, George Zheng and his company Ichi Trade (NZ) Ltd were fined a total of $42,500 plus costs after they pleaded guilty in February 2007 to various similar charges brought under the Medicines Act 1981. George Zheng and Ichi Trade (NZ) Ltd have appealed against the penalties.

ENDS

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