Prescribing Advice for GPs

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Meprobamate licence suspension recommended

The European Medicines Agency (EMA) has recommended (PDF) that the marketing authorisations for all meprobamate containing medicines are suspended over the next 15 months.

A recent review looked at all available data on the safety and efficacy of these medicines. It was concluded that there is a risk of serious and potentially fatal side effects even when taking this drug under normal conditions of use. The risks were even higher in cases of unintended overdose due to the narrow therapeutic window.

The EMA are advising doctors to stop prescribing meprobamate over the next 15 months and to consider using alternative treatments in line with national recommendations. Patients are to discuss their treatment at their next routine appointment.

Action: Clinicians should be aware of this recommendation. Meprobamate is not widely used but it may be prudent to search clinical systems to identify those patients affected by this recommendation.

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6 Comments to “Meprobamate licence suspension recommended”

  1. […] for meprobamate will be cancelled by the end of 2016 and UK manufacturing has ceased. This was recommended by the European Medicines Agency in 2012. Any patient who is currently receiving a […]

    Pingback by Drug Safety Update - April 2016 - Prescribing Advice for GPs — April 19, 2016 #
    Reply

  2. The only risks with this medication are overdose, no different to phenobarbital. This medication should not be withdrawn for such serious conditions as anxiety disorders where patients are refractory or tolerant to benzodiazepines. This is yet another over reaction of the EMA not based on clinical evidence.

    Comment by Dave — August 12, 2014 #
    Reply

    1. @Dave,

      The review states this: "there was a risk of serious and potentially fatal side effects, such as coma, in patients taking meprobamate-containing medicines under normal conditions of use". So, the risks are not only associated with overdose.

      Also there is a Q&A document that lists the clinical data that were reviewed in making this decision so to claim the decision is not based on evidence would seem to be unjustified.

      Comment by Matthew Robinson — August 17, 2014 #
      Reply

  3. I was put on this tablet and it worked so much for me but only to go for my repeat prescription and to be told that it was out of stock was so devastating. Please help I was feeling much better within a month.

    Comment by Loveday — April 22, 2012 #
    Reply

    1. I have been on this drug for 30 yrs. I was a nervous wreck before taking this medication it has helped me live in the outside world after being agraphobic for many years. I feel distraught that its being banned in UK.

      Comment by karen — November 6, 2012 #
      Reply

      1. @Karen,

        There are other alternatives that will hopefully work just as well for you. You need to see your doctor to discuss the options that might be suitable for you (and perhaps inform them that this drug is being withdrawn - maybe they don't know yet).

        Comment by Matthew Robinson — November 6, 2012 #
        Reply

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