Pharmaceutical Drugs

Paracetamol warning

Stronger warning labels will be added to paracetamol sold in the United States in an effort to curb accidental overdoses that have lead to hundreds of deaths in that country. Anso Thom reports.

Stronger warning labels will be added to paracetamol sold in the United States in an effort to curb accidental overdoses that have lead to hundreds of deaths in that country.

Paracetamol is the main ingredient in more than a hundred over-the-counter cold and headache remedies.

The move comes after evidence presented to a panel of expert scientists revealed that 100 people died and more than 2 000 are hospitalised each year in the US as a result of liver damage from unintentional overdoses of paracetamol.

The National Hospital Discharge Survey in the US indicated that there were an average of 26 256 hospitalisations per year related to paracetamol overdoses.

In South Africa, Andy Gray, of the Department of Experimental and Clinical Pharmacology at the Nelson R Mandel School on Medicine confirmed that paracetamol poisoning (inadvertent and deliberate) was common. However, he said the challenge was finding a safe way to regulate access to something so ubiquitous.

He said a few years ago the pack sizes of paracetamol (such as Panado) available on general sale were reduced (max 20 tablets/100ml) to avoid some dangers. A toxic dose in adults could be as little as 10 tablets.

Gray added that some would say stronger measures were needed in South Africa: “However, if made pharmacy-only, access in rural areas might be compromised,” he said.

He added that written warnings in English were least effective in the same (rural) areas.

The New York Times reported that Dr Louis Cantilena, chairperson of the US panel, was especially disturbed to hear that many consumers mistakenly mixed more than one paracetamol product because they failed to realise that their prescription pain killer and cold medicine both contained the drug.

The panel called for every package of paracetamol to say in bold type that it contained the ingredient and suggested warnings that taking more than the recommended dose could cause liver damage.

The British Medical Journal reported that many were surprised that the United States had not considered following the United Kingdom’s policy of reducing the public’s ease of access to paracetamol over and above the warnings.

The BMJ claimed that the FDA advisers had not seriously considered following the lead of the United Kingdom and some other countries, which had introduced measures to restrict the numbers of tablets per pack and replacing bottles full of loose pills with “blister packs”.

The option was reportedly not suggested for consideration by FDA officers appearing before the advisory committee despite the fact that tentative evidence indicates that such reforms in the United Kingdom may have significantly reduced the number of drug related poisonings, liver transplantations, and deaths.

The reforms in the United Kingdom have also led to a substantial reduction in annual sales of tablets containing paracetamol and paracetamol compounds, from 123 billion to 84 billion.

More than 200 people attended the two-day hearing in the United States, which focused first on paracetamol and then on aspirin and non-steroidal anti-inflammatory drugs, said to be associated with more than 16000 deats in the United States every year as a result of gastrointestinal bleeding.

Paracetamol has been on the market since 1955 and is thought to be the most widely used pain reliever in the world.

Registrar of South Africa’s Medicines Control Council, Dr Precious Mtsoso, could not be reached for comment.

About the author

Anso Thom