- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Drug Safety Update - May 2013

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2013 (PDF).

This issue contains drug safety advice informing clinicians that tolvaptan (Samsca®) which is used in the treatment of hyponatraemia secondary to inappropriate antidiuretic hormone secretion (SIADH) has been associated with an increased risk of of liver injury. Liver function tests are advised in anyone who reports symptoms that may indicate liver injury. This section also advises that thalidomide increases the risk of haematological second primary malignancies.

A Yellow Card update advises that Black Triangle drugs, or drugs that are the subject of closer safety monitoring, are now part of an EU wide scheme. Clinicians are reminded to report any suspected adverse reactions in patients taking

Finally, the stop press section advises clinicians of a stock issue affecting liothyronine 20 microgram tablets from Amdipharm Mercury. Alternative products are being sourced but the interchangeability is uncertain and bioequivalence is not assured. As such clinicians are advised to be aware that symptom control and thyroid-stimulating hormone (TSH) status may be affected by this shortage. Dose adjustments and closer monitoring may be required in such cases.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.