Strengthened warnings for medicines containing opioids

Medicines containing opioids for non-cancer pain will now be given stronger warnings about the risk of dependence and addiction on the patient information leaflets, the Medicines and Healthcare products Regulatory Agency (MHRA) announced.

Healthcare professionals have been asked by the MHRA to discuss these warnings with any patient taking or planning to take an opioid-containing medicine. These discussions should also involve agreement of a treatment plan, including how long treatment should last, to minimize the risk of dependence.

Additional warnings are now to be added to the patient information leaflet to reinforce those warnings, making it clear that the medicine is an opioid, which can cause addiction, and that there can be withdrawal symptoms if people stop taking it suddenly. More information and warnings are provided throughout the leaflet.

Opioids have a serious risk of dependence and addiction, especially with long-term use. Following concerns raised about the prescribing rates of opioids in the UK, the Opioid Expert Working Group (EWG) of the Commission on Human Medicines (CHM) developed a set of recommendations to improve information for prescribers and patients and to protect public health. These recommendations were fully supported by CHM and formed the basis of the MHRA’s new warnings.

While the CHM continues to consider opioids as important and effective medicines in the treatment of short-term pain relief, they have advised against their long-term use in the treatment of non-cancer pain, due to the risk of dependence and addiction.

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