The Paracetamol-dextropropozyphene combination brands, widely marketed in the country, would soon come under the safety monitoring. The Indian drug regulatory agencies including the National Pharmacovigilance Advisory Committee (NPAC), following the recent ban on this combination in the UK, have taken note of the serious ADRs of this combo drug reported by the Medicine and Healthcare products Regulatory Authority (MHRA).

The UK has now decided to stop allowing the use of the drug on all new patients and on youngsters below 18 years as the MHRA has called for a total ban on the drug in a phased manner.

If the drug in question is Co-prozamol (paracetamol + dextropropozyphene) in UK, in India there are several combinations, which contain these two drugs. Wockhardt and Jagson Pal are among the leading players in this segment.

According to the Committee on Safety of Medicine of MHRA, there is no robust evidence that efficacy of this combination product is superior to full strength paracetamol alone in either acute or chronic use. The committee noted that it had not been able to identify any patient group in whom the risk: benefit may be positive. On the contrary, it noted, "Each year there are 300-400 fatalities following deliberate or accidental drug overdose involving co-proxamol in England and Wales alone."

"In relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose. Pharmacokinetic and pharmacodynamic interactions with alcohol further reduce the threshold for fatal toxicity," the committee has observed.

The UK has called for total withdrawal of the drug over the next six to twelve months. "During the withdrawal phase, interim restrictions and warnings regarding the use of co-proxamol should be introduced to the product information," it stated.

Interestingly, the dextropropozyphene combinations are likely to be off the shelves in the country today due to a totally different reason. This is because the combination fits into the category of narcotics and psychotropic drugs, a category that has been boycotted by the drug retailers and wholesalers of the country. The reason has nothing to do with the safety of the drug but is more about trade issues where the chemists want an amendment to the Narcotic Drugs and Psychotropic Substances (NDPS) Act of 1985, an Act passed with an objective to put a check on drugs abuse and illegal trafficking of certain psychotropic substances within and outside the country as per the international protocol.