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

MEDICINE RECALL – MAREVAN® (warfarin) 3mg tablets (blue)
- Recall of Marevan® (warfarin) 3mg tablets (blue)

Thursday 28 January 2010 Auckland, New Zealand

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 the Marevan® (warfarin) 3mg tablets (blue) may contain more medicine than the labelled amount.

If a patient has taken a Marevan ® (warfarin) 3mg tablet (blue) from the affected batch, it may place the patient at an increased risk of bruising and/or bleeding. Signs of increased anticoagulant activity include abnormal bleeding or bruising, vomiting with the appearance of coffee 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 are advised 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 free replacement, if required.
4. Contact the doctor or clinic that prescribed their medicine for advice on whether further 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 affected by 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 their medication, 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 not affect any other batches or strengths, or any other GSK products.

GSK sincerely regrets any inconvenience and is confident that supply to customers will not be affected by this recall activity.

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

Issued on behalf of GSK by Consultus. For media enquiries please contact:
Adelle Foster, Consultus
Tel: 09 354 0557
Mobile: 027 517 2804
Email: [email protected]

About MAREVAN
Marevan® (warfarin) is an anticoagulant treatment used widely in New Zealand to thin blood to help prevent blood clots.
Marevan® (warfarin) is an anticoagulant belonging to a class of drug called coumarins or vitamin K antagonists. Marevan® (warfarin) works by antagonising vitamin K in the blood (which is needed to help blood clot), therefore inhibiting the formation of clotting factors II, VII, IX and X. It slows the clotting time of the blood. Higher levels of warfarin in the body means a slower clotting time.
Marevan® (warfarin) can be used for different indications (medical conditions).
For more information refer to the Marevan® (warfarin) Data Sheet or the MAREVAN Consumer Medicine Information on the Medsafe website at www.medsafe.govt.nz.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.co.nz