December 22, 2006 2:26am CST
CROCIN 1000:- Paracetamol, an old drug used mainly for treatment of fever, has been in use the world over for several decades now. In most countries the drug is sold as an OTC product and is usually taken with no medical supervision. India and China are probably the two largest producers of this drug. And there are a number of brands and generics of the drug available in the market today. In India, amongst paracetamol brands and generics, the market leader, undoubtedly, is Crocin. Until recently, the maximum strength of a paracetamol formulation used to be 500 mg including that of Crocin. SmithKline Beecham which owns this brand, has recently introduced an extension of this brand namely Crocin 1000 containing 1000 mg of paracetamol in one tablet. Crocin 1000 is being promoted as a pain reliever for chronic conditions like osteoarthritis, rheumatic arthritis, headache, toothache, period pain and muscle pain on the label of the bottle. The label does not carry any warning on the hazards of an overdose or prolonged usage on vital human organs. At the same time the label assures that Crocin 1000 does not irritate the stomach and the maximum daily dose can go upto 4000 mg. The new brand is marketed in a bottle of 40 tablets. The safety of this high strength brand in the Indian market has raised serious concerns amongst consumer action groups and drug experts particularly in the wake of findings of a recent study conducted by Dr. William Lee of the University of Texas. The study has proved that there is a direct link between paracetamol overdose and liver failure. Dr Lee had tracked more than 300 cases of acute liver failures at 22 hospitals in the US and found 38 percent of these associated with excessive paracetamol usage. The study also found the paracetamol link to 35 percent of the 307 adults suffering from severe liver damage at 6 US hospitals. In UK, 20 people had to undergo liver transplant as a result of paracetamol induced liver poisoning in 1997.The British government, subsequently, had to impose restrictions on the sale of paracetamol preparations as an OTC product. These reports should be alarming to drug control machinery in India with regulatory machinery being weak in several states. First of all, marketing permission for a 1000 mg single dose of paracetamol should have been granted with adequate medical consultation, as it is an OTC product. The claim of the company about the product's effectiveness for osteoarthritis, rheumatic arthritis, etc sound definitely unethical and exaggerated. Karnataka drug controller should have known what claims the company was planning to print on the label of this product before issuing the manufacturing licence. As claims on an OTC product like this can lead to its overconsumption, the product needs to be recalled and should be allowed to be marketed only with all possible cautions in the interest of public safety.
15 Jan 07
Whatever the result of the findings, my doctors have always advised us never to take it on an empty stomach. The say that one must take at least a couple of bsicuits or slices of bread if not more before taking it.