High-dose ibuprofen linked to small increased CV risk, EMA committee confirms
This article was originally published in Scrip
Executive Summary
A European Medicines Agency committee has confirmed that there is a small increase in the risk of cardiovascular problems such as heart attacks and stroke in patients taking high doses – 2,400mg or more – of ibuprofen, and has recommended that the labelling of products containing the anti-inflammatory drug should be updated to reflect this risk.
You may also be interested in...
Next Generation OTC Painkillers And Cough Syrup On Cards For German Switch Committee
Rx-to-OTC switches of the painkillers dexibuprofen and single-pill combinations of ibuprofen and paracetamol as well as the cough medicine levodropropizine, all for oral use, will be considered at the next German Expert Committee for Prescription meeting on 13 July.
UK Regulator Calls For More Patient Involvement In Trial Design
UK plans for a flexible and streamlined clinical trial regulatory regime are now out for consultation, covering areas such as investigational medicinal products, greater patient involvement in trial design, and lighter-touch oversight of low-intervention trials.
UK Kicks Off Landmark Overhaul Of Clinical Trial Framework
The UK regulatory agency, the MHRA, is planning to establish a “world-class sovereign regulatory environment” for clinical trials to support the development of new innovative medicines. In the first of two articles, we look at the MHRA’s proposals to slim down trial approval processes, lighten the safety reporting burden, and introduce greater transparency of trial registration and results.