European Medicines Agency concludes authorizations for opioids using polymethacrylate-triethylcitrate CR be suspended

The European Medicines Agency (EMEA) has finalized a review of modified-release oral opioids of the World Health Organization level III scale for the management of pain. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of most of these medicines continue to outweigh their risks, but that the existing warnings on the interaction of these medicines with alcohol should be made consistent across the class.

However, for modified-release oral opioids that contain a polymethacrylate-triethylcitrate controlled-release system the Committee recommended suspension of the marketing authorizations, until the manufacturers have reformulated them so that they are more stable in alcohol.

Modified-release oral opioids of the WHO level III scale for the management of pain are strong painkillers used to treat pain that has not been controlled with other medicines. They release the active substance slowly, often over many hours, to reduce the number of times patients have to take the medicine every day. Included in the class are morphine and the related medicines oxycodone and hydromorphone, the EMEA explained.