What is the appropriate MHRA regulatory response?

摘要

Concern has been expressed repeatedly in recent years about inadequate oversight by regulatory authorities of drugs and medical devices. Recently, the Medicines and Healthcare Products Regulatory Agency (MHRA) recommended restricting the prescription of strontium ranelate for osteoporosis.1 This was because strontium increased the risk of myocardial infarction (relative risk 1.6,95% Cl 1.07 to 2.38), although it did not increase mortality, in a pooled analysis of about 7500 participants in randomised controlled trials.