New Advice On OTC Analgesics Containing Codeine

The Medicines and Healthcare products Regulatory Agency (MHRA) recently announced new advice on over the counter (OTC) medicines containing codeine and dihydrocodeine (DHC) to minimise the risk of overuse and addiction.

This follows recent advice from the government's scientific advisory body, the Commission on Human Medicines (CHM).

The package of measures include clear and prominently positioned warnings on the label and Patient Information Leaflet (PIL) about the risk of addiction, and the importance of not taking these medicines for longer than three days.

The revised guidance on the use of these products will focus on treating moderate pain not relieved by simple painkillers such as paracetamol and ibuprofen.

There will also be updated controls on advertising to ensure the new warnings are clearly presented.

Large packs of effervescent codeine containing products will no longer be sold in the pharmacy but will be available on prescription, which further strengthens the voluntary action taken by manufacturers in 2005 on pack size reduction. All packs containing up to 32 tablets remain available for sale through a pharmacy.

MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said that taken in the correct manner and for the right purposes, codeine and DHC are very effective and acceptably safe medicines.

"However, these products can be addictive and we are taking action to tackle this risk," she said.

"The MHRA is ensuring that people have clear information on codeine containing medicines on what they are to be used for and how to minimise the risk of addiction.

"Anyone who has concerns should speak to their pharmacist or a doctor."

The MHRA's action is being taken in parallel with the Department of Health's review of policy on addiction to prescription and OTC medicines.

SOURCE: MHRA