Effectiveness of FDA accelerated approval for cancer drugs

 A recent assessment published in the JAMA has reviewed the cases of 93 cancer drug indications granted accelerated approval by the FDA from December 11, 1992, through May 31, 2017. Confirmatory trials reported that 20% (n = 19) produced an improvement in overall...

The vexation of alert fatigue

“Alert override” has been the focus of much research in health informatics, and the extent to which alerts are overridden are often viewed as a marker for reduced alert effectiveness. Using alert override does assume that alerts are being read and...

5 moments for medication safety

The World Health Organization (WHO) has created a resource intended to promote safer use of medicines. The resource, principally intended for consumers, identifies key opportunities to reduce the risk of harm associated with the use of medications, with each moment...

Efficacy and safety of apixaban across body weight spectrums

Despite some guidelines that caution against the use of non–vitamin K antagonist oral anticoagulants for people who weight >120 kg or ≤60 kg,  because of a lack of data, a recent post-hoc analysis of the ARISTOTLE study (Apixaban for Reduction in Stroke and Other...

Heparin-induced thrombocytopenia

Heparin‐induced thrombocytopenia (HIT) is a serious complication with a prothrombotic basis. Antibodies to platelet factor 4 and heparin facilitate a profound and rapid decrease the platelet count and a risk of serious thrombosis. Accurate diagnosis is essential in...

Antidepressants – more is not necessarily better

Optimisation of antidepressant use has remained elusive despite an increased range of pharmacotherapy options. A recent systematic review and dose-response meta-analysis of double-blind, randomised controlled trials involving fixed doses of five selective serotonin...