Patient Safety

Codeine Linctus: Reclassification from P to POM

Codeine linctus has been used as a cough medicine for many years. Although the evidence for its effectiveness in short-term cough is limited, it may be effective in the treatment of long-term cough (lasting over 8 weeks) and as an opioid medicine, is known to be addictive.

Recent safety information has revealed that codeine linctus is being used recreationally for its opioid effects, rather than for its intended use as a cough suppressant. Significant concerns have been raised concerning the use of codeine linctus as an ingredient in the recreational drink known as ‘Purple Drank’ (alternative names: ‘Lean’, ‘Sizzurp’, ‘Dirty Sprite’). As codeine linctus is used in varying amounts in this drink, consumers may not be aware of how much they are taking, and this can have serious risks such as loss of consciousness, respiratory suppression and death. Concomitant use with a central nervous system (CNS) depressant, such as alcohol, sedatives or other medicines, will further increase these risks. 

Following the results of a public consultation and the advice of the Commission on Human Medicines (CHM), the Medicines and Healthcare products Regulatory Agency (MRHA) has advised that codeine linctus will only be available as a prescription-only medicine (POM).

It will take time for the new labelling to appear on the products. All market authorisation holders (MAH) are in the process of updating their product licences to reflect the change to POM. Once the licences have been updated the MAHs have committed to implement the changes to their product information within 3 months. 

To avoid any ‘stockpiling’ following this update, all existing codeine linctus stock should now be treated as POM.

Advice for Pharmacy Teams:

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