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Codeine linctus to be reclassified to POM status over 'risk of abuse'

Codeine linctus is set to be reclassified from a pharmacy (P) medicine to prescription-only medicine (POM) status, the medicines regulator has announced.

The Medicines and Healthcare products Regulatory Agency (MHRA) today (February 20) said it will reclassify codeine linctus, an oral solution or syrup licensed to treat dry cough in adults, to a prescription-only medicine due to "the risk of abuse, dependency and overdose".

Codeine linctus, an opioid medicine, has been previously available to buy in pharmacies under the supervision of a pharmacist, but will now only be available on prescription following an assessment by a healthcare professional, it said.

The regulator added that it made the decision to reclassify the cough suppressant medicine following a consultation with independent experts, healthcare professionals and patients that received 992 responses.

Read more: MHRA mulls codeine linctus P to POM switch amid ‘recreational’ use concerns

The MHRA told C+D that the reclassification process is still ongoing, and the manufacturers are in the process of updating their product information to reflect the decision to reclassify.

Five brands will be affected by the reclassification:

  • Codeine Linctus BP (LCM Limited, and Pinewood Laboratories Limited) 
  • Bells Healthcare Codeine Linctus 15mg/5ml Oral Solution (Bell Sons & Company [Druggists] Limited) 
  • Care Codeine 15mg/5ml Oral Solution Sugar Free (Thornton & Ross)
  • Galcodine Linctus (Thornton & Ross)
  • Pulmo Bailly (Dendron Brands Limited)

 

“Purple Drank”

 

 

The regulator said that the media has filed “increasing reports” of misuse of the opioid medicine since 2019, in particular as an “ingredient in a recreational drink” also known as “Purple Drank”.

Responses to the MHRA’s consultation, which launched in July following the Yellow Card reports, identified “the pressure pharmacists were under to provide the medicine to those suffering from addiction”, it added.

However, the medicines watchdog urged patients to “speak to a pharmacist for advice”, such as if they feel they have become dependent on or addicted to codeine linctus.

Read more: ‘Overwhelmed’ locum suspended for four months over codeine payment mix-up

It also urged the public not to buy the opioid from an unregistered website.

MHRA chief safety officer Dr Alison Cave said that the regulator also made its decision after receiving Yellow Card reports “in relation to abuse”.

“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,” she added.

Read more: Pharmacist struck off for illegitimate codeine supply after threats to family

The regulator stressed that alternative non-prescription cough medicines are available for short-term coughs to sooth an irritated throat, such as honey and lemon mixtures and cough suppressants.

The MHRA launched its month-long public consultation on whether to make the opioid cough medicine prescription-only in July, citing concerns about “recreational” use.

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