Powerful cough syrups could go back on prescription in the UK for fears people could become addicted.
Five over-the-counter codeine products will be restricted if the measure goes ahead.
Drug control agencies are concerned about increasing cases of serious and sometimes fatal side effects.
Health chiefs are also spooked by reports that the drug is being used recreationally for its powerful opioid effects, rather than medicinally.
Now the Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on the preparation of syrups only by prescription.
These are the five codeine cough syrups the UK regulator wants to prescribe only after worrying reports of people becoming addicted to the opioid.
If given the go-ahead, it would mean that Britons who want codeine linctus, a specific type of codeine medicine, would be questioned by a GP before being allowed to buy it.
The MHRA said the move would only affect five products: Codeine Linctus BP, Bells Healthcare Codeine Linctus, Care Codeine, Galcodine Linctus, Pulmo Bailly.
These sell for as little as £3.20.
Other over-the-counter codeine products, such as tablets containing the pain reliever, would not be affected.
MHRA officials said that since 2018 they have received 116 reports of recreational drug abuse and addiction to codeine medications, including cough syrups.
The MHRA data also shows that reports of serious and fatal side effects have skyrocketed in recent years, with a record 35 deaths in 2022, the most recent full year available.
Codeine is an opioid, a class of pain relievers in the same family as morphine, heroin, and fentanyl.
As with other opioids, people can become addicted.
Dr Alison Cave, the MHRA’s director of security, said: ‘Codeine linctus is an effective medication.
“But because it is an opioid, its misuse and abuse can have significant health consequences.”
In total, the MHRA received 243 reports of serious and fatal adverse reactions to codeine medications in 2022 and 277 in 2021.
There have been 95 such reports in 2023 so far.
These reports, made using the Yellow Card reporting scheme, are not direct confirmation that a drug was responsible for or contributed to a medical problem, and could just be coincidental.
Professor Claire Anderson, president of the Royal Pharmaceutical Society, welcomed the move.
“Medications should maximize the health benefits for the patient with minimal risk,” he said.
“We believe that there is insufficient strong evidence for the benefits of codeine linctus in treating cough safely and adequately.
“We also have significant concerns about its misuse and addictive potential, as well as the risk of overdose.”
He added that considering there were many other codeine-free products capable of relieving a dry cough, the benefits of keeping linctus codeine as an over-the-counter option were limited.
This table shows codeine-related serious and fatal events reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) by year. The dark green portions of the bars represent fatal reports only, while the light green portions are serious but non-fatal events.
Pharmacists say that with many non-codeine cough syrups available, the easy availability of products containing the potentially addictive opioid was “questionable.”
“With studies showing that up to 60 percent of people are genetically predisposed to opioid dependence, the role of codeine linctus in treating what is ultimately a self-limiting condition is questionable,” he said.
Opioid addiction has become a growing concern in both the UK and the US, as people secretly become addicted after taking painkillers as part of medical treatment.
The US in particular has seen devastating scenes of ‘Zombieland’ opiate addiction in some cities.
The MHRA audience consultation It will run until August 15.
