Breathe Deeply: Safety Concerns Over Boehringer Ingelheim Corporation's Spiriva

Several months after concerns were raised about the safety of the blockbuster Spiriva inhaler that is used to treat chronic obstructive pulmonary disease, a previously unpublished epidemiological study has surfaced. And the data, which has been published in BMJ Open, indicates the medication is associated with an increased risk of angina, heart attacks and stroke compared with a long-acting beta agonist, although a lower risk of total mortality was found. The data was actually contained in a 292-page briefing document that was submitted by Boehringer Ingelheim, which markets Spiriva, for a November 2009 FDA panel meeting (see page 158) and which we reported previously (read here). Until now, though, a full vetting of the study, which was known as THIN-II, had not been available for public consumption.