NZ world-class non-prescription analgesics safety

July 3, 2009

MEDIA STATEMENT

New Zealand has world-class regime for safety of non-prescription analgesics

The New Zealand Self-Medication Industry (NZSMI), the industry body representing non-prescription consumer healthcare products, said today that moves in the U.S. to impose further regulatory measures on acetaminophen (paracetamol) are not warranted in New Zealand as consumers here had already benefited from a range of safeguards to ensure the safe and quality use of these products.

Paracetamol has had a very long history of safe and effective use in New Zealand and the risks are minimal when used according to instructions on the label.

The comments follow a decision by an advisory committee to the U.S. Food and Drug Administration (FDA) recommending a lower maximum dose for over-the-counter acetaminophen, known in New Zealand as paracetamol.

NZSMI executive director, Mr Tim Roper said the situation in the U.S. was significantly different to that in New Zealand.

"The two regulatory environments are fundamentally different. In New Zealand there are pack size restrictions which do not apply in the US. Larger packs up to maximum of 100 dosage units and combination and children's products can only be sold in pharmacies where professional advice is available when required. Only small pack sizes may be sold in other retail outlets such as supermarkets.

"In the U.S. tubs of 500 tablets can be sold in supermarkets. Given the concerns about safety, it is somewhat surprising that the advisory panel rejected a recommendation that would have seen these pack sizes reduced," he said.

Industry has also invested heavily in improving label comprehension to ensure the quality use of these products. Consumer-focused labelling assists consumers to select the most appropriate product and to use the product safely and to best effect.

NZSMI works closely with MedSafe in determining whether additional consumer safeguards may be required.

"We are conscious that as an industry, we have an obligation to be proactive in ensuring that we adopt best practice in all aspects of analgesic use including issues such as labelling, packaging, dosage, and availability of public information," he said.

It is important that all medicines are used strictly according to label instructions and if symptoms persist to seek advice from a healthcare professional.

ENDS

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