ROCKVILLE, Md. Data from a recent review of a treatment for chronic obstructive pulmonary disease do not support allegations that it raises the risk of stroke, heart attack or death, the Food and Drug Administration announced Thursday.
The FDA reviewed a 5,992-patient study of the Spiriva HandiHaler (tiotropium), made by Pfizer and Boehringer Ingelheim as a treatment for COPD, a disease that includes emphysema and chronic bronchitis.
In March 2008, an FDA Early Communication described data submitted by one of the companies suggesting a small increased risk of stroke in patients who had taken the inhaler’s active ingredient. An update in October of that year highlighted two additional publications suggesting an increased risk of stroke, heart attack and death in patients using the drug.