Cough syrup or codeine linctus could no longer be available over the counter because of concerns it is addictive and can lead to serious health problems.
Rising numbers of reports of drug abuse and dependence to codeine medicines are being made to the UK medicines safety regulator.
It now wants views on reclassifying it as a prescription-only medicine because of fears of misuse.
Pharmacists also say they are worried about the overdose risk.
Codeine linctus is an oral solution or syrup containing the ingredient codeine phosphate, which is sold as a cough remedy in pharmacies.
But some people are also using it for its opioid effects – to feed an addiction to pain-relieving medication – and the Medicines and Healthcare products Regulatory Agency (MHRA) says the rules around how people get hold of it should be tightened.
“Codeine linctus is an effective medicine, but as it is an opioid, its misuse and abuse can have major health consequences,” said Dr Alison Cave, chief safety officer of the MHRA.
The problem has been getting noticeably worse in the last five years, with increasing numbers of reports of misuse and criminal activity linked to codeine, often promoted through social media.
The MHRA says it has received 116 reports of recreational drug abuse, dependence and/or withdrawal to codeine medicines, including codeine linctus, since 2018.
There were 277 serious and fatal adverse reactions to medicines containing codeine in 2021 and 243 in 2022, and there have already been 95 this year.
As a result, the regulator has launched a consultation to gather views from health professionals and members of the public on making the medicine available only when prescribed by a GP.
Pharmacists welcomed the move, saying there was “insufficient robust evidence” for the benefits of codeine linctus for treating coughs safely.
“We also have significant concerns about its misuse and addictive potential, as well as the risk of overdose,” said Prof Claire Anderson, president of the Royal Pharmaceutical Society.
She said there were many non-codeine based products which people could use for a dry cough, which would probably go away on its own anyway.
Up to 60% of people worldwide may be prone to opioid dependence, studies suggest.
Cough syrups have also been in the news for a different reason in India, where some Indian-made cough syrups were linked to deaths in The Gambia and Uzbekistan.
The Indian government has made it compulsory for cough syrup makers to get samples tested before exporting their products.
