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

Drug Safety Update - June 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2016 (PDF).

This issue highlights the recently identified signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients taking canagliflozin (Invokana® or Vokanamet®). The following recommendations are made:

This issue informs clinicians that there have been rare reports of etonogestrel implants (Nexplanon®) having reached the lung via the pulmonary artery. It is recommended that an implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at the earliest opportunity. If an implant cannot be located within the arm, perform chest imaging. A letter has been sent direct to healthcare professionals about this safety concern.

This issue also reminds clinicians of the potential for miconazole containing medications to have serious interactions with warfarin. There have been reports of serious bleeding events in patients taking the combination and the risk extends to miconazole oral gel. The available data for this interaction are being reviewed to determine whether further measures are required to minimise the risks to patients.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.