Tiotropium Linked to Possible Increased Risk of Stroke

Laurie Barclay, MD


March 19, 2008

March 19, 2008 — The US Food and Drug Administration (FDA) is reporting a possible increased risk of stroke with use of tiotropium (Spiriva HandiHaler, Boehringer Ingelheim Pharmaceuticals, Inc), according to an ongoing safety review posted March 18 on MedWatch, the FDA's safety information and adverse event reporting program. Spiriva contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease (COPD).

"Boehringer Ingelheim and [the] FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva," MedWatch states. "It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke."

A pooled analysis by Boehringer Ingelheim of the safety data from 29 placebo-controlled clinical studies yielded preliminary estimates of stroke risk of 8 of 1000 patients treated for 1 year with Spiriva and 6 of 1000 patients treated for 1 year with placebo. In these trials, which included approximately 13,500 patients with COPD, the estimated excess risk of any type of stroke caused by Spiriva is 2 patients for each 1000 patients using Spiriva for 1 year.

The FDA cautions that it has not yet confirmed these analyses with the manufacturer. Although pooled analyses are useful in highlighting potential safety issues, they have inherent limitations and uncertainty, mandating further investigation with other data sources.

"Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information," MedWatch concludes. "This early communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs."


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