FDA Issues Safety Alert for Drug Spiriva

The U.S. Food and Drug Administration has issued a safety alert for Spiriva, a drug used to treat certain symptoms of chronic obstructive pulmonary disease.

The FDA said ongoing safety monitoring conducted by the drug’s manufacturer — the Boehringer Ingelheim Corp. — has identified a possible increased risk of stroke in patients who take Spiriva to treat bronchospasm associated with COPD.

An analysis of safety data from 29 placebo controlled clinical studies estimates the risk of stroke are 8 patients per 1,000 patients treated for one year with Spiriva, and 6 patients per 1,000 patients treated for one year with placebo.

That, the FDA said, means the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1,000 patients using Spiriva during a one year period.

The FDA said it is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. The agency said patients with questions about the new information should not stop taking Spiriva before talking with their physician.