The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2013 (PDF).
This update contains drug safety advice reminding clinicians of the need to monitor cardiac function when starting or re-starting fingolimod (Gilenya®). This issue clarifies that the same first-dose monitoring as for treatment initiation should be repeated if treatment is interrupted as follows:
- 1 day or more during the first 2 weeks of treatment
- more than 7 days during weeks 3 and 4 of treatment
- more than 2 weeks after one month of treatment
It is recommended that patients are made aware to consult a doctor about their medication if they miss doses as described above.
The stop press section advises of the withdrawal of Tredaptive® after a recent study failed to demonstrate that the benefits of therapy outweigh the risks.
This same section also advises of an increased risk of suicidal behaviour and ideation with roflumilast (Daxas®). Roflumilast is licensed for maintenance treatment of severe chronic obstructive pulmonary disease and is already known to increase psychiatric disorders such as insomnia, anxiety, nervousness and depression. Post marketing data has identified an increase in suicidal behaviour also with one instance of completed suicide. It is recommended to avoid use in individuals with a history of depression associated with suicidal ideation or behaviour, for patients to monitor for and report mood changes during treatment and for treatment to be stopped if psychiatric symptoms develop or worsen.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.