UK MHRA explains co-proxamol withdrawal

29 January 2007

Further to renewed interest, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a position on the withdrawal of co-proxamol:

This notes that co-proxamol is implicated in 300-400 deaths from overdose a year. There is growing concern prompted by UK research which shows that the compound is implicated in almost one fifth of drug-related suicides and is second only to tricyclic antidepressants as an agent of fatal overdose. In response, the MHRA's Commitee on Safety of Medicines (CSM) conducted a review of the risks and benefits of co-proxamol. The CSM considered all the available data for co-proxamol and, in January 2005, advised that it should be withdrawn from the market on the grounds that the benefits of taking this drug are not considered to outweigh the risks:

It was decided to withdraw co-proxamol over an extended period of time in order to allow long-term users an opportunity to move to suitable alternatives. The withdrawal will be phased over a period of up to 36 months. Some makers have already withdrawn co-proxamol and a few will phase theis until the end of 2007. The MHRA has issued CSM pain management guidance to help doctors find the best options for individual patients.

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