Date Published: 13 March 2009
Health warning issued under Section 98 of the Medicines Act 1981
The Director-General of Health, Stephen McKernan, is warning the public about the potential health dangers associated with four unapproved medicines manufactured in Samoa and Tonga and sold from general retailers in New Zealand.
This statement about the four medicines is issued by the Director-General under Section 98 of the Medicines Act 1981 and follows a statement made on 11 December 2008 in relation to three similar Samoan products.
Three of the medicines being distributed are labelled as originating from Multipharm in Apia, Samoa. It is believed that they have been imported by a number of individuals and are sold by various retail outlets. The fourth product appears to be manufactured in Tonga and the extent of distribution is not yet known.
The products are:
* ‘Multipharm’s Fluid Magnesia‘, a product that is labelled
as being suitable for babies younger than 3 months to be used for bringing up
wind, settling tummy upsets and relieving colic pains The label does not state
the ingredients that are included in the product.
* ‘Multipharm Vai Lafa’, a product intended for the treatment of ringworm. The label states that the product contains salicylic acid.
* ‘Multipharm’s Vai Tane’, a product intended for the treatment of fungal infections. The label states that the product contains salicylic acid.
* 'Vaikahi Mixture' (Tukia Pharmaceuticals Ltd) is labelled for uses including bloating and constipation. The label states the product contains magnesium sulphate and light magnesium carbonate.
The safety, quality and efficacy of these medicines are unknown as they have not been assessed and approved for supply in New Zealand through the medicines approval process.
In particular, the ‘Multipharm’s Fluid Magnesia’ product is labelled for use in young babies. It does not have maximum daily dosages on the label. It has not been put through the rigorous assessment required for medicines to be safely used in such circumstances. The Director-General believes that without these comprehensive safeguards, this product poses a safety risk to babies and young children.
The Multipharm’s Vai Lafa and Multipharm’s Vai Tane products pose a safety risk because they are not adequately labelled with instructions for use. These products have not been assessed and approved for the treatment of ringworm or fungal infections. Medicines sold in New Zealand must be correctly labelled and meet required standards for quality, safety and effectiveness.
The Vaikahi Mixture is intended for the treatment of constipation. The label has no instructions or warnings in English and the medicine could pose a safety risk if taken incorrectly. Medicines sold in New Zealand must be labelled in English. This product has not been assessed and shown to meet required standards for quality, safety and effectiveness.
"Consumers should immediately stop using the products and seek medical advice from their doctor if they, their babies or children have been unwell when using any of these products," said Mr McKernan.
This warning also applies to any other similar unapproved medicines that may be on sale in New Zealand. Medsafe is undertaking further investigations into the supply of medicines originating from the Pacific Islands and sold by retailers in New Zealand. Under the medicines legislation, retailers, distributors and importers are responsible for the products they sell and they must ensure that they have approval for any medicines they wish to sell prior to selling them. This ensures that all medicines for sale have been assessed for their quality, safety and efficacy and that they can be marketed lawfully in New Zealand.