The European Medicines Agency has started a review of oral (by mouth) methadone medicines that also contain povidone. Methadone-containing medicines are used in rehabilitation programs in patients dependent on opioids, such as heroin, to prevent or reduce withdrawal symptoms in order to decrease the chance of relapse.
The review was triggered by the Norwegian Medicines Agency, NOMA, following a number of reports of kidney failure in former or current drug abusers which may be linked to the misuse of methadone oral solutions containing certain types of povidone. These medicines are intended for oral use only; however, some patients may abuse oral methadone preparations and inject them into a vein. If a medicine containing these forms of povidone is abused in this way, there are concerns that povidone can accumulate inside the cells of vital organs. This is not considered to occur when oral methadone medicines are used as recommended.
As a result of these concerns, on 8 April Norway suspended the only methadone-containing oral solution that contains povidone present on the national market, and has now asked the Agency to review whether there are implications for the use of all oral methadone medicines containing povidone in other European Union (EU) Member States.
The Agency will therefore review this safety concern and its impact on the benefit-risk balance of oral methadone medicines that contain povidone, and will issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
The Agency invites all stakeholders (e.g. healthcare professionals, patients’ organisations, the general public) to submit data relevant to this procedure. Full details are available under the ‘data submission’ tab.