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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

MHRA clarifies co-proxamol position

The Medicines and Healthcare products Regulatory Agency (MHRA) has clarified what is expected to happen following the cancellation of marketing authorisations (MAs) for co-proxamol at the end of 2007.

The MHRA announced in January 2005 that co-proxamol would be withdrawn at the end of 2007 following a phased withdrawal. This decision was reached after a safety review of the risks and benefits of co-proxamol concluded that the "efficacy of co-proxamol is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable".

The following action points have been recommended:

  • No further stock released into the supply chain after 31st December 2007
  • Existing stock already in the supply chain can be supplied until the product expiry date
  • Manufacturers to accept returned surplus stock from the supply chain
  • For a very small number of patients unlicensed co-proxamol can be supplied, on the responsibility of the prescriber

It is also likely that the price of co-proxamol will increase following the withdrawal of the marketing authorisation.

Action: Clinicians should ensure that audits have been undertaken to change co-proxamol prescriptions to more suitable and licensed alternatives. Where alternatives have been fully explored and have proven unsuitable, unlicensed co-proxamol may be an option.

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11 Comments to “MHRA clarifies co-proxamol position”

  1. I pray every night that the persons responsible for the withdrawal of Co-Proxamol, get Arthritis as bad as I have, and suffer the same pain on a daily basis.
    I have had Co-Proxamol now for the past 20 years, and now I cannot find anything to replace it.
    A curse on the people at the top, I hope they come to suffer as many as are suffering because of there idiotic decision.

    Comment by Michael Rudge — August 14, 2016 #

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