The non-prescription pharmaceutical industry has dismissed the need to impose restrictions on paracetamol despite plans by the Therapeutic Goods Administration (TGA) to review the use of medicines containing the drug.
An expert panel yesterday advised the US Food and Drug Administration to reduce the single maximum dose of the common pain killer known in the US as acetaminophen from 1000mg to 650mg, as well as the maximum daily dose, out of concern that patients were taking too much of the drug, leading to potential liver failure and overdoses.
The maximum daily adult dose in Australia is 4000mg while the maximum single dose is 1000mg.
The TGA said it was following developments in the US but stressed that its counterpart had not yet made a decision.
"Nevertheless, the TGA will review the current use and misuse of paracetamol-containing medicines in Australia to identify if any regulatory action is warranted and will seek the advice of its OTC expert advisory committee if necessary," a TGA statement said.
The Australian Self-Medication Industry (ASMI), however, said similar restrictions were not warranted in Australia because of better consumer safeguards.
"The two regulatory environments are fundamentally different," ASMI executive director, Juliet Seifert said.
"In Australia 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 US, tubs of 500 tablets can be sold in supermarkets."
The TGA said its reviews carried out in 1998 and 2003 led to improvements in dosage instructions and labelling, and raised the awareness of the public and health professionals of the hazards of paracetamol.