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.