The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced that codeine linctus is to be reclassified as a prescription-only medicine due to the risk of abuse, dependency and overdose. 

This follows a consultation launched by the MHRA in July 2023 after Yellow Card reports indicated instances of the medicine being abused, rather than for its intended use as a cough suppressant. The consultation ran for four weeks, closing on 15 August 2023. 

Recent safety information indicates that codeine linctus is being misused recreationally for its opioid effects, instead of its intended use as a cough medicine. This poses a serious risk of addiction and potentially fatal overdose.  

Codeine linctus is an oral solution intended to treat adults with dry coughs. Opioid medications bind to specific receptors in the brain that reduce the perception of pain while also producing feelings of euphoria, relaxation, and sedation, making the drugs addictive, and potentially leading to dependence with prolonged use.

Data from the Office for National Statistics revealed an increase in the annual number of deaths where codeine was involved from 88 deaths in 2011 to 200 deaths in 2021. 

In July 2023, the MHRA revealed a three-year corporate plan to create a quicker and more predictable legal landscape. The plan’s emphasis on the maintenance of public trust includes several initiatives, which include a pilot of public hearings on major safety issues throughout 2024 and 2025. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In the announcement accompanying the reclassification, the MHRA’s chief safety officer Alison Cave said: “Patient safety is our top priority. Codeine linctus is an effective medicine for long-term dry cough, but as it is an opioid, its misuse and abuse can have major health consequences.” 

In the US, an ongoing opioid crisis demands alternatives to addictive pain medications. While some people are addicted to illicit opioids such as heroin, many are addicted to legal drugs such as codeine. Earlier this year, Vertex Pharmaceuticals announced plans to submit a new drug application for its non-opioid pain medication to the US Food and Drug Administration following positive results from a Phase III programme, marking a significant development in the field.