The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2012 (PDF).
This update contains strengthened cardiovascular monitoring advice for fingolimod (Gilenya®). This drug is a niche product that is used in the treatment of relapsing-remitting multiple sclerosis that fails to respond to beta-interferon or is severe and getting rapidly worse. It is already known that this drug can cause bradycardia and perhaps atrioventricular block after the first dose and as such specialist initiation is recommended with a 6 hour period of monitoring.
There have been cases reported recently where cardiovascular events have occurred after this 6 hour window of monitoring so new recommendations have been made including:
- Pre-treatment 12 lead ECG
- Continuos ECG monitoring and hourly blood pressure and pulse assessment for 6 hours after the first dose
- A 12 lead ECG at 6 hours after the first dose
- The above monitoring extended until clinically important cardiac effects resolve
- If fingolimod is discontinued for more than 2 weeks, it is restarted under the above conditions
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.