Revisiting Paracetamol!

Revisiting Paracetamol! 

By Dr  Guru Prasad Mohanta

Dept Of Pharmacy,Annamalai University

Paracetamol (often called Acetaminophen) is perhaps one of the most widely used medicines and is believed to be safe. This has been indicated as antipyretic and analgesic; available without prescription and falls under schedule K of the Drugs and Cosmetics Act. Sale of simple paracetamol tablets does not require even a sale license for selling in villages subject to certain restrictions. In addition to simple paracetamol in a product there are many combination products in the market. Following the USFDA guideline the Government of India too issued instruction to restrict the quantity of paracetamol to 325 mg only in a combination product. This is just to avoid liver injury risk. Even after the Government of India’s guideline, it has been reported that many combination products still continue to have more than 325 mg paracetamol.

Following the discussion on availability of higher amount of paracetamol in Fixed Dose Combinations at Drugs Consultative Meeting, Country’s highest regulatory authority, Drugs Controller General India (DCGI), issued clarification that limit of 325 mg Paracetamol is applicable only to FDCs with other pain relieving or anti-inflammatory agents. Other FDCs and single ingredient product can continue to have 500 mg or higher strength.  The USFDA’s direction issued in 2011 to limit quantity of paracetamol to 325 mg per dose in prescription only medicines is complied by many pharmaceutical companies. Ironically the USFDA has not bothered to issue instruction on Over the Counter Paracetamol products and these products continue to have the strength at 500 mg per dose. The liver injury risk is same whether the paracetamol product comes under prescription only medicine or over the counter one. The liver injury risk is related to the quantum of paracetamol. USFDA statement continues “there is no evidence to show that higher amounts of acetaminophen doses provide additional benefit that outweighs the added risks for liver injury”. The study has shown that some adults developed early signs of liver toxicity after taking just 4 grams per day of acetaminophen, or just over eight "extra-strength" tablets of 500 mg acetaminophen in a day. The current recommended daily maximum dose is 3 grams per day, the amount in six 500 mg tablets.

The different strength of products both for paediatric and adult use add further confusion.  The patients often fail to recognize the duplication and continue taking two or more products containing paracetamol leading to severe liver injury. Even in absence of USFDA’s clear instruction; the Public Citizen Health Research Group, a prestigious civil society group in USA, advises the consumers not to take more than 325 mg paracetamol per dose not exceeding 3 g daily.   This makes a sense and same should be applicable to Indian population too! We can at least advise the patient to limit to 6 tablets of paracetamol 500 mg per day and limiting the total amount of paracetamol to not more than 3 g per day from all sources. The patient needs to be advised to avoid alcoholic drinks while taking paracetamol. This is all in the best interest of the patient, a fundamental component of medical ethics.