Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, myocardial infarction, or cardiovascular death in patients with chronic obstructive pulmonary disease, the Food and Drug Administration announced.
The FDA has now completed its safety review of this product “and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events,” according to an agency statement.
The Spiriva HandiHaler, marketed by Boehringer Ingelheim and Pfizer, was approved in 2004 for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is administered once daily.
The FDA has been conducting a safety review of the Spiriva HandiHaler since the manufacturer submitted data suggesting that treatment with tiotropium was tied to a small increased risk of stroke compared to placebo (2 cases per 1,000 treated patients). It announced the review in March 2008. In October 2008, the agency issued a statement about two published studies that suggested an increased risk of stroke, MI, and death in patients treated with tiotropium.
The latest FDA statement said that a 4-year study comparing treatment with the Spiriva HandiHaler to placebo in almost 6,000 patients with COPD found no increase in the risk of these outcomes in the treatment arm.
The study was reviewed by the FDA's Pulmonary-Allergy Drugs Advisory Committee in November 2009. In a near unanimous vote, the panel agreed that the data adequately resolve the potential safety concerns for stroke and adverse cardiovascular outcomes associated with this product.