A number of over-the-counter analgesics in the UK are to carry new labels that will warn of the risk of misuse and addiction.
The Medicines and Healthcare products Regulatory Agency has announced new advice on OTCs containing codeine and dihydrocodeine, following recommendations from the government’s scientific advisory body, the Commission on Human Medicines. The changes will include “clear and prominently positioned warnings” on the label and patient information leaflet about the risk of addiction, and the importance of not taking these medicines for longer than three days.
The revised guidance will focus on treating moderate pain not relieved by simple painkillers such as paracetamol and ibuprofen. Noting that there will also be “updated controls on advertising” to ensure the new warnings are clearly presented, the MHRA added that large packs of effervescent codeine-containing products will only be available on prescription, “which further strengthens the voluntary action taken by manufacturers in 2005 on pack size reduction”. Packs containing up to 32 tablets will still be on sale through a pharmacy.
The MHRA’s director of vigilance and risk management of medicines, June Raine, said that taken in the correct manner, codeine and DHC are very effective and acceptably safe. “However, these products can be addictive and we are taking action to tackle this risk,” she noted, claiming that the agency “is ensuring that people have clear information” to minimise said risk.
Of the 300 million packs of analgesics sold in the UK each year, around 27 million contain codeine or DHC, noted the Proprietary Association of Great Britain. Sheila Kelly, executive director of the trade association which representing manufacturers of OTCs, said the group supports the changes. She added that “There is very little advertising for products containing codeine but we will immediately update our Medicines Advertising Code to ensure the addiction warning is included“.
Ms Kelly went on to say that painkillers containing codeine are very effective for short term relief and are safe when used according to the instructions. Combining codeine with paracetamol, ibuprofen or aspirin is particularly effective for ailments such as migraine, backache, dental and period pains and “the vast majority” of people use codeine-containing products “have no need to worry that they are doing themselves any harm.”
The changes will affect a number of well-known brands such as Co-codamol, Nurofen Plus, Panadol Ultra and certain Solpadeine products.
