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NZ world-class non-prescription analgesics safety
News - Health
Friday, 03 July 2009 20:16

Press Release: New Zealand Self-Medication Industry.

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.

Scoop

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muppet said:

...
What a crock of shit.

The group also voted—36-1—to include a black box warning if the drugs remain on the market, said the AP. A black box is the agency’s strongest warning. The group also voted 21-16 to lower current maximum dosages of OTC acetaminophen, which is currently at four grams, the equivalent of eight pills in a product such as Extra-Strength Tylenol, said the AP. In another vote—24-13—the group agreed on a maximum single dose of 650 milligrams, a drop in, for instance, the current single dose of Extra-Strength Tylenol, which is 1,000 milligrams for two tablets, said the AP, citing the group as saying the current dose should be available by prescription only. FDA Panel Votes To Eliminate Two Popular Painkillers

Yesterday, said the AP, the FDA panel voted 21-16 to lower current maximum dosages of OTC acetaminophen, currently at four grams, the equivalent of eight pills in a product such as Extra-Strength Tylenol, said the AP. The group agreed (24-13) on a maximum single dose of 650 milligrams, a drop in, for instance, the current single dose of Extra-Strength Tylenol, which is 1,000 milligrams for two tablets, said the AP, citing the group as saying the current dose should be available by prescription only. FDA Meets On Acetaminophen

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.

Safegauards for the consumer? or safeguards for the pharmaceutical company and the distributor of panadol for instance? Reccommended single dose 1000mg!

Should these meds become prescription only how big a loss of revenue does Dow face?
July 03, 2009

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