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.

The agency's March 2008 communication described data submitted by the manufacturer of Spiriva HandiHaler that suggested there may be a small excess risk of stroke in patients using tiotropium compared to placebo (2 cases of stroke per 1,000 treated patients). The updated early communication from October 2008 reported two additional publications that suggested an increased risk of death, heart attack or stroke in patients using tiotropium or drugs that work similarly to tiotropium.