Health warning Re: Samoan and Tongan medicine

Health warning issued under Section 98 of the Medicines Act 1981 - Samoan and Tongan medicines

13 March 2009

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.

ENDS

Questions and Answers

What is wrong with these products?

All four products are being sold illegally as they have not been approved for sale through the New Zealand medicines approval process.

Multipharm’s Fluid Magnesia is being sold for the treatment of ‘wind and tummy pain’in babies and young children. The manufacturing standards for this medicine have not been assessed and so no assurance can be given about its quality. It is labelled with a three year expiry date which may be inappropriate because it may deteriorate during that time or become contaminated with bacteria during use.

Multipharm Vai Lafa and Multipharm Vai Tane contain salicylic acid in a flammable alcohol solution and they are intended for the treatment of ringworm and fungal infection. There are no instructions for use. These medicines have not been assessed and approved for the treatment of ringworm or fungal infections and may not be effective. The conditions under which these products have been manufactured have not been assessed so their quality cannot be guaranteed.

Vaikahi mixture has not been approved for sale in New Zealand and may not meet the required quality, safety and efficacy standards.

If a consumer is taking or using one of these products what should they do?

Consumers are being warned to immediately stop taking or using these products and seek medical advice from their doctor if they, their babies or children become unwell when using the products.

Adverse reactions to these products should be reported to the Centre for Adverse Reactions Monitoring: http://www.carm.otago.ac.nz

Consumers can also report any concerns to Medsafe: http://www.medsafe.govt.nz

Have these products been removed from sale?

It is possible that these products may still be on sale. Medsafe welcomes information about retailers who continue to sell them.

It is possible that other similar unapproved products may also be on sale. Medsafe welcomes any information from consumers about the sale of such products.

Medsafe is continuing to investigate the matter and may take further regulatory action if required.

Important advice to traders

Under the medicines legislation, manufacturers, distributors and importers are required to obtain approval before they sell or distribute products intended for a therapeutic purpose. Retailers cannot lawfully sell products that have not first been approved for sale under the provisions of the Medicines Act 1981.

Under section 20 of the Medicines Act 1981, Ministerial consent is required for the sale or distribution of new medicines in New Zealand.

A breach of this requirement carries substantial penalties.

An individual who sells, distributes or advertises the availability of any medicine without Ministerial consent is liable on conviction to imprisonment for a term not exceeding six months or a fine not exceeding $20,000.

A body corporate which sells, distributes or advertises the availability of any medicine without Ministerial consent is liable on conviction to a fine not exceeding $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 that the law is complied with.

ENDS

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