US FDA backs safety of Pfizer/Boehringer's Spiriva HandiHaler; Pfizer admits EU investigation; gets sued over Chantix

The US Food and Drug Administration has said that recent data do not show a connection between a popular inhaler and previously reported risks of stroke, heart attack and death. The Spiriva (tiotropium) HandiHaler, used for the treatment of chronic obstructive pulmonary disease (COPD), is made by family-controlled German drug major Boehringer Ingelheim and co-marketed in the USA by pharmaceutical behemoth Pfizer.

This is a follow-up to previous early communications issued in 2008 by the FDA describing a potential increase in the risk of stroke, heart attack, or death from a cardiovascular cause related to the use of the Spiriva HandiHaler. The FDA has now completed its review and believes the available data do not support an association between the use of the product and an increased risk for these serious adverse events, and is advising health care professionals to continue to prescribe Spiriva HandiHaler as recommended in the drug label.