A comparison of adverse event and fracture efficacy data for strontium ranelate in regulatory documents and the publication record.

ABSTRACT:

Objective

Recently, the European Medicines Agency reported that strontium ranelate increases myocardial infarction risk in postmenopausal women, 8.5 years after it was registered for use in osteoporosis. Unreported serious adverse events in clinical trials for other pharmaceuticals have been described in recent years. We assessed reporting of adverse events and fracture efficacy of strontium.

Methods

We compared data on adverse effects (myocardial infarction, venous thromboembolism and pulmonary embolism) and fracture efficacy of strontium in publicly available regulatory documents with data in publications retrieved from searching PubMed.

Results

We identified 5 regulatory documents and 9 primary publications of 7 randomised, placebo-controlled trials of strontium th

SUBMITTER: Bolland MJ 

PROVIDER: S-EPMC4187454 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature