Stronger warnings on opioids

  • Date: 29 September 2020

WARNINGS over the risk of dependence and addiction in opioid medicines are to be toughened up, the regulator MHRA has announced.

Patient information leaflets will have extra warnings added, while healthcare professionals are being asked to discuss risks with patients.

Drug labels will clearly state that the medicine is an opioid which can cause addiction, and that there can be withdrawal symptoms if people stop taking it suddenly.

Clinicians should agree a treatment plan with patients, including how long treatment should last, to minimise the risk of dependence.

Minister for Innovation Lord Bethell said: "Opioid addiction is a serious and life-threatening issue and people need to be aware of these risks before they take medicines with such a high rate of dependency.

"It is vital that patients are given the right support and guidance on the dangers of long-term use and the strengthening of these labels is a crucial step forwards in protecting patients and saving lives."

These latest measures come in response to concerns raised last year about 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.

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

Read the MHRA’s latest guidance here

This page was correct at the time of publication. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

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