BMJ study reinforces safety concerns for Tiotropium mist inhaler

Wednesday, 15 June 2011

A new BMJ meta-study has reinforced the safety concerns around the Tiotropium mist inhaler (marketed as Spiriva Respimat), showing a 52% increased risk of all-cause mortality, compared with placebo.

The study, published in the BMJ on  14 June 2011 (BMJ 2011;342:d3215) conducted a systematic analysis and meta-review of 6522 patients with COPD.

The study:


In a BMJ Editorial reviewing the research ( Christopher Cates, of St George's Medical School, said:
"The indirect evidence that is currently available suggests that the Handihaler is a safer bet than the Respimat. If patients have a strong preference for the mist inhaler, the possible increased risk in mortality will need to be shared with them."


In November 2010 (before this study was published) the MHRA issued the following advice in a Drug Safety Update (


Information and advice for healthcare professionals: