electronic Medicines compendium
Information has been added on weight based dosing as has warning that in patients with existing CV risk factors, substitiution therapy with FVIII may increase CV risk. ADR data from trial in treatment naïve patients, aged 0 to 6 years have been added.
Revised SPC: Xarelto (rivaroxaban) 2.5 mg film-coated tablets
electronic Medicines compendium
DRESS syndrome and anaphylactic reactions have been added to SPC as adverse effects. SPC has been amended to advise interaction with fluconazole/erythromycin/clarythromycin is likely not clinically relevant in most patients but can be potentially significant in high-risk patients.
JAMA Neurology
Review of 5 RCTS (n=39,398) found 15 to 20mg dose of rivaroxaban (RV) once daily is linked to increased risks of intracranial haemorrhage vs. aspirin (2 trials; OR, 3.31; 95% CI, 1.42-7.72), while smaller daily doses of RV and apixaban were not, suggesting dose dependent risk.
Revised SPC: Eliquis (apixaban) 2.5 mg film-coated tablets
electronic Medicines compendium
The SPC has been updated to advise that care should be taken if patients are treated concomitantly with SSRIs or SNRIs, due to the increased bleeding risk.
Effect of aspirin in vascular surgery in patients from a randomized clinical trial (POISE‐2)
British Journal of Surgery
RCT (n=10,010) found that perioperative withdrawal of chronic aspirin therapy did not increase cardiovascular or vascular occlusive complications (HR for death or MI = 1.48, 95% CI 0.71-3.09 for aneurysm repair and 1.16, 0.62-2.17 for surgery for occlusive vascular disease).
The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
