MEDICINE RECALL – MAREVAN® (warfarin) 3mg tablets (blue)

Thursday 28 January 2010, 4:45PM
By GlaxoSmithKline New Zealand

Recall of Marevan® (warfarin) 3mg tablets (blue) GlaxoSmithKline New Zealand (GSK), in consultation with Medsafe, is recalling all Marevan(warfarin) 3mg tablets (blue) dispensed to patients since 23 November 2009.

Marevan® is an anticoagulant treatment used widely in New Zealand to thin blood to help prevent blood clots. Marevan® 3mg tablets are blue in colour.The recall is due to a manufacturing problem that could mean that a limited number of theMarevan® (warfarin) 3mg tablets (blue) may contain more medicine than the labelledamount.If a patient has taken a Marevan ® (warfarin) 3mg tablet (blue) from the affected batch, itmay place the patient at an increased risk of bruising and/or bleeding.

Signs of increasedanticoagulant activity include abnormal bleeding or bruising, vomiting with the appearance ofcoffee grounds or blood, blood in the urine or stool, or black tarry stools.Patients who have received their Marevan® 3mg tablets (blue) after 23 November 2009 areadvised to:

1. Not suddenly stop taking this treatment.

2. Seek advice and replacement tablets as soon as possible.

3. Return the Marevan® (warfarin) 3mg tablets (blue) to their pharmacy for freereplacement, if required.

4. Contact the doctor or clinic that prescribed their medicine for advice on whetherfurther testing or monitoring is required.

5. Contact their doctor immediately if any ill effects are noticed.GSK is working with doctors and pharmacists to contact any patients who may be affectedby this batch recall.

“Patient safety is our first concern and the results of our investigations to date give us confidence that this is an isolated incident. If patients have any concerns about theirmedication, they should discuss these with their pharmacist or their health practitioner,” said Geoff McDonald, General Manager at GSK New Zealand.

Marevan® (warfarin) is available in three different strengths – 1mg (brown), 3mg (blue) and 5mg (pink). This recall only affects the Marevan® (warfarin) 3mg tablets (blue) and does notaffect any other batches or strengths, or any other GSK products.GSK sincerely regrets any inconvenience and is confident that supply to customers will notbe affected by this recall activity.

If patients or medical professionals require any additional information, they can contactGlaxoSmithKline New Zealand on 0800 696 308.