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Wednesday, 05 March 2014 10:53

Anticoagulation news items. Week commencing 17th February 2014

Revised SPC: Pletal (cilostazol) 50 mg and 100 mg tablets

Electronic Medicines Compendium

Indication restricted to 2nd line use. 4.2: specialist initiation/review after 3 months. 4.2, 4.4 & 4.5: Reduce dose to 50mg BD if with strong CYP3A4 inhibitors 4.3 & 4.4: New contraindications and warnings, including concomitant use with 2 or more anticoagulants/antiplatelets.


Revised SPC: Plavix (clopidogrel) 75mg and 300mg tablets

Electronic Medicines Compendium

The SPC has been updated with warning about increased risk of bleeding with concomitant use of SSRIs and clopidogrel.


Outcomes of Temporary Interruption of Rivaroxaban Compared with Warfarin in Patients with Nonvalvular Atrial Fibrillation: Results from ROCKET AF


Risk of a Thrombotic Event after the 6-Week Postpartum Period Analysis of ROCKET AF trial (n=14,236) found that temporary interruptions (3-30 days) of oral anticoagulation is common and associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin.


Risk of a Thrombotic Event after the 6-Week Postpartum Period

New England Journal of Medicine

This US study (n=1,687,930;1015 thrombotic events) reported elevated thrombosis risk that persisted until at least 12wks post delivery, though absolute risk increase after 6wks was low. Risks/benefits of continuing treatment for high-risk women after 6 wks require investigation.


Dabigatran (Pradaxa) lawsuits in US due to start in August


US courts are scheduled to start hearing cases in August against Boehringer Ingelheim, who is facing more than 2000 lawsuits over claims that dabigatran caused severe and fatal bleeding. Claimants accuse Boehringer of not having sufficiently warned of these risks.


Treatment of Venous Thromboembolism

Journal of the American Medical Association

This review of the aetiology of VTE and the 3 phases of VTE treatment (acute, long-term and extended) concludes that further study to understand individual patient risks is needed to make ideal treatment decisions.


How effective is tranexamic acid for acute gastrointestinal bleeding?

British Medical Journal

This article on tranexamic acid for the treatment of acute GI bleeding is one of a series that highlight areas of practice where management lacks convincing supporting evidence. The authors discuss the available evidence and make recommendations, in light of the uncertainty.


Drug Safety Update: Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small

Medicines and Healthcare products Regulatory Agency

A review of the latest evidence on the risk of thromboembolism in association with combined hormonal contraceptives (CHCs) has concluded that the risk of blood clots with all low dose CHCs is small and the benefits of CHC far outweigh the risk of serious side effects.


The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service.
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