Medsafe warns of "natural health" hazards

The New Zealand Ministry of Health's medicines and medical devices regulator Medsafe is warning New Zealanders to be aware of what they're buying when shopping for herbal remedies, following charges brought against a Chinese herbalist in Auckland.

In the Auckland District Court, 46-year-old George Zheng and his Company, Ichi Trade (NZ) Ltd have been fined a total of $42,500 plus costs after both pleaded guilty in February to various charges brought under the Medicines Act 1981. Mr Zheng pleaded guilty to one charge each of advertising a ‘new’ medicine and sale of a prescription medicine other than by a pharmacist in a pharmacy and his Company pleaded guilty to one charge of advertising and five charges of selling a ‘new’ medicine.

On sentencing Zheng and Ichi Trade (NZ) Ltd, Judge Aitken commented that “…in the absence of any assessment by health professionals as to the suitability of the person seeking to purchase the tablets, coupled with a complete lack of any proper assessment of the quality, safety and efficacy of these pills, together with the known risk of both Sildenafil and Sibutramine, leave me in no doubt that there was a significant risk of real harm to consumers from the defendants’ offending”.

The charges were laid after Ministry officials as part of a surveillance operation noticed a sign in the window of Mr Zheng's Panmure Chinese herbal clinic advertising "Natural Viagra", in June 2006. A purchase of the ‘Natural Viagra’ was made and a search of the premises was subsequently carried out. Several ’new’ medicines were found, including products containing the prescription medicines sildenafil and sibutramine. Viagra is the only product containing sildenafil that is approved for distribution in New Zealand and Reductil is the only approved product containing sibutramine. A ‘new’ medicine is a medicine that has not been approved for distribution in New Zealand.

"In the absence of adequate regulation, this case demonstrates that consumers simply can't be assured about the safety or quality of the "natural" health product they are purchasing," said Derek Fitzgerald, Medsafe Team Leader, Compliance.

He says the defendant was claiming to sell a "natural" medicine which includes a perception that the product is safe, when in fact he was 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 unless these products have Ministerial consent to market", says Derek Fitzgerald.

Background and drug information:

During its investigation Medsafe seized several products from the premises of Ichi Trade, and found that they contained prescription medicines. Three contained the substance sildenafil - the active ingredient present in Viagra 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 contra-indicated 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.

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.

Medsafe is particularly concerned about the safety of one of the products (labelled “Kang Da”), as it was found to contain nearly twice the maximum approved dose of sildenafil in a single capsule. Following receipt of the test results in July 2006, the Director-General of Health issued a statement pursuant to Section 98 of the Medicines Act 1981. The statement warned the public of the safety risks of using the medicines mentioned above and stated that sildenafil is known to interfere with some heart medications and its use could be fatal to some individuals.