The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2010 (PDF).
This issue contains drug safety advice regarding a possible small increase in the risk of congenital cardiac defects when fluoxetine is taken early in pregnancy. This information comes from an analysis of epidemiological data from seven cohort studies. The background rate of congenital cardiac defects is approximately 1/100 and these results indicate that fluoxetine increased absolute risk to less than 2/100 pregnancies. This is similar to the risk increase seen with paroxetine. Clinicians are advised that this potential for increased risk should be considered in the context of the benefits of treating depression in pregnancy.
Attention is also drawn to inter-test differences when monitoring therapeutic levels of sirolimus. These differences may inadvertently lead to inappropriate dose adjustments. Care should be taken to ensure that the test used is unchanged before making dose adjustments.
Finally, Drug Safety Update has been accredited by NHS Evidence in recognition of the high quality guidance that is issued. Future Drug Safety Updates will be available at http://www.evidence.nhs.uk and will display the accreditation mark.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.