August 2, 2012 by  
Filed under Health Blog

TGA warns on liver damage with therapeutic dose paracetamol


Niamh Mullen
Medical Observer
Medicines Safety Update 2012; Volume 3, Number 4, August


THE TGA has issued a warning about the risk of liver damage caused by paracetamol even at therapeutic doses.

The regulator said the hepatotoxic effects of intentionally overdosing on the drug were well-known. It emphasised, however, that hepatotoxicity can occur due to accidental overdose and use “at normal doses”.

The TGA cited a study of 662 patients with severe paracetamol-induced hepatotoxicity in which 48% had not exceeded the recommended maximum daily dose of 4g.

“Risk factors for paracetamol hepatotoxicity include fasting, regular excessive alcohol use and concomitant use of drugs that induce cytochrome P450 (CYP) 2E1 (e.g. ethanol),” it said in the latest Medicines Safety Update.

It recounted the case of a 45-year-old woman who had been hospitalised for subacute bowel obstruction and treated with paracetamol 1g four times a day for eight days while remaining nil by mouth. She subsequently died of paracetamol-induced liver failure.

In another case a three-year-old chronically malnourished boy with a history of gastric dysmotility syndrome was hospitalised with fever and vomiting. He was intolerant to oral medication and prescribed the intravenous formulation of paracetamol Perfalgan 150mg (15mL). Due to confusion between mg and ml, he was given a single dose of 150mL (1500mg). He suffered transient hepatotoxicity, which responded to treatment with N-acetylcysteine.

To avoid this type of dosing error, the TGA said the dose volume in mL should be specified when prescribing, particularly for neonates and infants.

Another cause of hepatotoxicity was concomitant administration of oral and intravenous paracetamol, it said. The regulator reiterated the message that it was advisable to check no other sources of paracetamol had been given.

Sar Rooney’s comment:I never fail to be surprised when I hear of the regular or extended use of paracetamol (Panadol, Tylenol, Panamax, etc) or other analgesics (pain-killers) such as nurofen, by new patients that have come in seeking more natural pain relief. Many people falsely believe that these drugs are completely safe for them or their children, because they are so readily available without a prescription. Sadly, the gastrointestinal ulceration and/or liver tissue destruction from these medications can be extensive and liver function tests are usually too unsophisticated to identify the damage, particulary in the early stages. However, these drugs can cause fatal liver damage.

According to statistics on drug-induced liver toxicity (1), “Approximately 75% of the idiosyncratic drug reactions result in liver transplantation or death. Drug-induced hepatic injury is the most common reason cited for withdrawal of an approved drug”. The study also points out that, for reasons unknown, women are more likely to suffer from drug-induced liver toxicity than men.

Interestingly the above article states that the child suffering from acute liver toxicity (transient hepatotoxicity) was given N-Acetyl cysteine (NAC) which successfully treated this serious condition. Pure, medical-grade, NAC is something I have prescribed my patients for many years in the treatment of liver toxicity and heavy metal toxicity, as well as a preventative for stroke and heart attack and, when used in conjunction with other specific nutrients, it can also be an effective treatment for PCOS, excessive mucous conditions, Bipolar, OCD and other conditions. When used appropriately under the supervision of a health practitioner, this natural derivative of the amino acid L-Cysteine is a safe and effective treatment for a large number of health problems. Always consult your health practitioner for advice.

Yours In Great Health,

Sar Rooney BHSc., ND., DC., DASc., GDSc. (Hons), MATMS, MNHAA, MHATO

Naturopathic Medicine Practitioner, Lecturer, Researcher


Earth Medicine TM


Email: [email protected]



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Sar Rooney is a Naturopathic Medicine Practitioner specialising in Anxiety and Depression |Women’s Health| Hormonal Imbalances | Thyroid Disorders | Digestive Health | Genetic Polymorphisms (MTHFR/Pyroluria) | Nutritional Medicine | Optimal Wellness & Disease Prevention 

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1. Mehta, N., Pinsky, M. R. Drug-Induced Hepatotoxicity. Medscape. 27.6.12



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