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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - February 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2015 (PDF). This month there are three updates pertinent to primary care.

The TIOSPIR clinical trial has been published and found no significant difference in mortality when tiotropium is delivered via Respimat or Handihaler device. This is reassuring however patients with certain cardiac conditions were excluded from the trial. As such it is still recommended to take into consideration the risk of cardiovascular side effects in patients with certain cardiovascular conditions including:

  • recent myocardial infarction < 6 months
  • any unstable or life threatening cardiac arrhythmia
  • cardiac arrhythmia requiring intervention or a change in drug therapy in the past year
  • hospitalisation of heart failure (NYHA Class III or IV) within the past year

Clinicians are also reminded that the new drugs and driving offence will be enforced from 2 March 2015 in England and Wales. It is recommended that clinicians talk to patients who are on medicines with potential to impair driving and discuss the patient leaflet advice.

Finally this month there is a summary of letters sent to healthcare professionals since November 2014, including the discontinuation of carbocisteine 125mg/5ml oral solution.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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2 Comments to “Drug Safety Update - February 2015”

  1. It's worth noting that the MHRA will no longer be publishing pdf versions of each monthly issue on the new Gov.uk site. However, they are including a link to the pdf version at the end of each email alert they send out when each monthly issue is published. You can subscribe to these email alerts here: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/email-signup
    You can download the pdf of the January issue from here:
    and the pdf of the February issue from here:

    Comment by Trevor Batt — February 17, 2015 #

    1. @Trevor

      Thanks for that, I'll try to include the PDF link in future posts.

      Comment by Matthew Robinson — February 23, 2015 #

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