Warfarin: product information to be amended to give clearer, up-to-date advice

We continue to receive a substantial number of serious and fatal adverse event reports for warfarin through our Yellow Card Scheme.

Article date: December 2009

We continue to receive a substantial number of serious and fatal adverse event reports for warfarin through our Yellow Card Scheme.

We have recently reviewed the safety information for warfarin products to assess whether it is in line with information from Yellow Card reports, the current medical literature, and with current practice guidance. No new safety issues were identified during this review; however, the Summaries of Product Characteristics (SPCs) for all warfarin products are to be amended to give clearer and up-to-date advice to healthcare professionals. This update will also result in improved patient leaflets to ensure patients have consistent and appropriate information on this important medicine.

In particular, the core SPC provides advice on:

  • Timing of warfarin treatment after ischaemic stroke
  • Management of the patient before surgical or dental procedures
  • Patients at particular risk of haemorrhage
  • Interactions with herbal products, foods, and food supplements
  • Management of patients with significantly raised INR and/or haemorrhage

The updated warfarin core safety information, along with further information on the review, is available in a public assessment report on our website. In particular, healthcare professionals should ensure that they understand the contraindications to warfarin therapy, the relevant warnings, and the clinically significant drug interactions.

Serious and unexpected adverse effects relating to warfarin should continue be reported via the Yellow Card Scheme (www.yellowcard.gov.uk).

Further informaton on safer use of anticoagulant therapy

 

Article citation: Drug Safety Update Dec 2009, vol 3 issue 5: 7c.

 

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.