UK MHRA announces codeine linctus, an oral solution or syrup to treat dry cough, to be reclassified to prescription-only medicine due to risk of abuse and addiction
The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced that codeine linctus, an oral solution or syrup licensed to treat dry cough in adults, is to be reclassified to a prescription-only medicine due to the risk of abuse, dependency and overdose.
Codeine linctus is an opioid medicine which has previously been 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.
• Since 2019, there have been increasing reports in the media of codeine linctus being misused as an ingredient in a recreational drink, commonly referred to as ‘Purple Drank’.
• The decision to reclassify the medicine has been made following a consultation with independent experts, healthcare professionals and patients. 992 responses were received.
• The consultation was launched by the MHRA after Yellow Card reports indicated instances of the medicine being abused, rather than for its intended use as a cough suppressant.
• Responses to the consultation identified the pressure pharmacists were under to provide the medicine to those suffering from addiction.
• Dr Alison Cave, MHRA chief safety officer, 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.
• We would like to thank all the patients, independent experts and health professionals who responded to our consultation.
• As a result, and taking into account the reports we have received in relation to abuse, we have reclassified codeine linctus to a prescription-only medicine for the benefit of patients, carers and healthcare professionals across the UK.
• Codeine addiction can be a gradual process. If you have been taking it for a long time and want to stop, you can talk to your healthcare provider and reduce the amount you take slowly.
• If you feel that you are addicted or have concerns for someone who has been using codeine linctus for too long, you can seek advice on the NHS website. Support groups and self-help groups are also available such as Talk to FRANK.
• We ask people to report any adverse reactions from codeine linctus via the MHRA Yellow Card scheme.”
Alternative non-prescription cough medicines are available for short-term coughs to sooth an irritated throat, including honey and lemon mixtures and cough suppressants.
Patients are urged to speak to a pharmacist for advice and not to buy codeine linctus from an unregistered website as it could be dangerous.
• Professor Claire Anderson, president of the Royal Pharmaceutical Society, said: “We welcome the decision to reclassify codeine linctus to a prescription-only medication as a positive step to protect patient safety.
• This decision not only addresses concerns about the misuse and addictive potential of codeine linctus but also underscores the importance of prioritising patient well-being.
• There are many alternative non-codeine-based products available to treat a dry cough. As the most accessible of healthcare professionals, community pharmacists and their teams will continue to provide expert advice on managing dry cough and guide people towards suitable treatments.
• Michelle Riddalls, chief executive officer of PAGB, the consumer healthcare association said: “The over-the-counter (OTC) industry takes any issue relating to patient safety very seriously. Following evidence of the recreational use of codeine linctus, and in line with our consultation response, we support the reclassification of codeine linctus to a prescription-only medicine.
• Patient safety and wellbeing is paramount for manufacturers of OTC medicines. Alongside the MHRA, companies that make OTC products in the UK continually monitor the safety of medicines via routine pharmacovigilance measures.
• The decision to reclassify codeine linctus demonstrates that the reclassification system is effective; this will ensure that people are only able to access medicines that allow them to self-care safely.”
The Agency announced that further information is available in the Drug Safety Update. - The brands which will be reclassified are 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) and Pulmo Bailly (Dendron Brands Limited).
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
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