The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2013 (PDF).
This issue contains drug safety advice informing clinicians that there have been reports of acquired haemophilia occurring in association with clopidogrel. Clinicians should be aware of this very rare but serious condition; it may easily be missed due to the established risk of bleeding associated with clopidogrel treatment. There have been 12 reported cases of acquired haemophilia worldwide in users of clopidogrel. It is estimated that more than 153 million patient worldwide use clopidogrel.
The stop press section informs reader that there have been 69 complaints about dorzolomide / timolol (Cosopt®) preservative-free single-dose eye drops. A new design of dropper was introduced in July 2013 but it seems to be difficult to use and increases the risk of eye injury. A revised design will be introduced early in 2014. In the meantime patients using this product may need assistance or additional education in the safe self-administration of eye drops.
As is expected at this time of year, this issue also contains the annual drug safety quiz that tests drug safety knowledge based on the updates published this year. Completion of the quiz may be a useful way to demonstrate continuing professional development.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.