Other safety alerts
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| European Union: CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone |
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The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 has endorsed by consensus the recommendation to suspend the marketing authorisation of methadone oral (by mouth) solutions containing high molecular weight povidone. These products will remain suspended until they have been reformulated. Additionally, the CMDh agreed that methadone tablets that contain low molecular weight povidone should remain on the market with changes to the product information.
Methadone is used in rehabilitation programs to prevent or reduce withdrawal symptoms in patients dependent on opioids such as heroin. Some oral formulations of methadone also contain the additive povidone, which is available in different molecular weights. While these medicines are intended for oral use only, some patients may misuse oral methadone formulations by injecting them into a vein. If a medicine containing high molecular weight povidone (known as K90) is misused in this way, the povidone is not excreted from the body and accumulates inside the cells of vital organs, which may cause serious harm.
The safety of oral methadone medicines containing povidone was reviewed by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), following reports of serious adverse events in former or current drug abusers in Norway, which led to the suspension of methadone oral solutions containing povidone K90 from the Norwegian market.
The PRAC assessed the available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone from post-marketing reports and the published literature, and a group of experts (which included pathologists and addiction experts) was consulted for advice. The PRAC concluded that risk minimisation measures would be insufficient to mitigate the risks with oral solutions containing high molecular weight povidone, and therefore recommended that these products should be suspended. They will need to be appropriately reformulated before being reintroduced on the European market.
For methadone tablets containing povidone of lower molecular weight (e.g. K25 and K30), the available data showed that this kind of povidone is excreted from the body and does not accumulate inside the cells as high molecular weight povidone does. Therefore, these products will remain on the market and changes will be made to the product information (SmPC and package leaflet) to reinforce the message that tablets are for oral administration only and must not be taken in any other way.
As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented in all EU Member States where these medicines are marketed, according to an agreed timetable. While these medicines are suspended, healthcare professionals should switch their patients to alternative methadone products.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002144.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are three registered pharmaceutical products containing methadone for oral use. Two of them are in oral solution form and one in tablet dosage form, but none of them contains povidone. All of them are prescription-only medicines. Related news has been released by the EMA and was posted on the Drug Office website on 12 April 2014 and 14 July 2014.
Ends/ Friday, July 25, 2014
Issued at HKT 14:00 |
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