Paracetomol (called acetaminophen in some countries) is a medication intended to treat pain and fever. The effects last between two and four hours. Often the drug is combined with other ingredients; for example, self-medication in fixed combination with aspirin and caffeine is used for the temporary relief of mild to moderate pain associated with migraine headache. The medication is regarded as safe when taken at the recommended doses; however, serious skin rashes can occur, and too high a dose can result in liver failure. The toxic dose is around 4 grams per day or greater. The issues with the liver fall under the general medical term hepatotoxicity.
Approval for the PledPharma trial has been agreed by the UK health regulator. The trial involves a new product called Aladote. The trial will review the safety and tolerability of Aladote. This will be in combination with the current recommended treatment for the prevention of acute liver failure due to paracetamol poisoning (using a drug called N-acetylcysteine).
Initial experiments, using animals, have shown Aladote may be effective at reducing liver damage, provided it is administered within a period more than eight hours after a paracetamol overdose (and up to twenty-four hours of the overdose having been taken). This time point is important because current treatments are designed to address complications arising from an overdose with eight hours; yet many people do not report problems until after eight hours have elapsed. The new study will take place in conjunction with the University of Edinburgh, using a team led by Dr James Dear.
In relation to the clinical timescale, Dr. Dear said: “During the first 24 hours after paracetamol poisoning people usually experience few or no symptoms. Therefore, many patients come to hospital at such a late stage that the current standard treatment is not sufficient to prevent acute liver failure.”
The issue of paracetamol poisoning is of medical importance. In the U.K. alone there are 50,000 emergency hospital admissions, with an average of 200 deaths, per year, as the result of paracetamol poisoning. Often people inadvertently take an overdose not realizing that many medicines contain paracetomol. In severe cases a liver transplant is required, which carries considerable risks to the patient.
