UK medicines regulator strengthens opioid warnings

People who take prescribed or over-the-counter medicines containing opioids for non-cancer pain will now be given stronger warnings about the risk of dependence and addiction, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

Opioids are known to have a serious risk of dependence and addiction, especially with long-term use. The MHRA's new warnings are based on recommendations made by the Opioid Expert Working Group (EWG) of the Commission on Human Medicines (CHM).

Healthcare professionals should discuss the new warnings with any patient who is taking or planning to take an opioid-containing medicine, the UK medicines regulator said. These discussions should also involve agreement of a treatment plan, including how long treatment should last, to minimize the risk of dependence.

Additional warnings will also be added to patient information leaflets, 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.

MHRA Director of Vigilance and Risk Management of Medicines, Sarah Branch, said: 'Last year, we announced that opioid-containing medicine packaging must carry warnings. Now, we are strengthening those warnings to ensure that opioid medicines are supplied with consistent information on how to manage the risk of addiction.

'This is a further step forward in helping to promote the safe use of these pain-relieving medicines.'

The CHM views opioids as important and effective medicines in the treatment of short-term pain relief, but advises against their long-term use in the treatment of non-cancer pain, due to the risk of dependence and addiction.

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