Spiriva HandiHaler Not Linked to Risk of Stroke, Heart Attack, Death: FDA

The FDA has concluded their investigation into potential side effects of Spiriva HandiHaler, and the agency indicates that they did not find a link between the chronic pulmonary obstructive disease (COPD) inhaler and an increased risk of heart attack, stroke or death.

FDA investigators began reviewing Spiriva HandiHaler in March 2008, after preliminary data from a four year study suggested that users may face an increased risk of strokes. In a statement released Thursday, the agency indicates that they found no connection between Spiriva and stroke or heart disease.

Spiriva HandiHaler (tiotropium) is a once-daily inhaled medication used for long-term maintenance treatment of bronchospasm linked to COPD. Since it was approved by the FDA in 2004, it has grown to dominate the market for COPD inhalers and has been used by millions of Americans.

The initial study that raised concerns about Spiriva involved a combined analysis of 29 clinical trials, which found that users may face a slight increase in the risk of stroke when compared to the use of a placebo. A subsequent study in October 2008 suggested that usrs may also face an increased risk of heart attack and death, in addition to the stroke risk.

The FDA review, Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT), looked at 5,992 COPD patients and compared the health effects of Spiriva with a placebo. Both FDA officials and the FDA Pulmonary – Allergy Drugs Advisory Committee reviewed data from UPLIFT and found no correlation between use of Spiriva and heart attack, stroke or sudden death.