The FDA has announced that it is currently working with Spiriva’s maker, German pharmaceutical company Boehringer Ingelheim, to evaluate the potential link between Spiriva and an increased risk of stroke.

Boehringer Ingelheim recently submitted to the FDA internal data from 29 clinical studies comparing the incidence of strokes in Spiriva patients to the incidence of strokes in patients taking a placebo. Based on the data, strokes occurred more often among patients taking Spiriva than those taking a placebo.

Spiriva Stroke Risk

The Boehringer Ingelheim studies suggesting that Spiriva increases the risk of stroke were conducted over several years and evaluated around 13,500 patients. Of the 13,500 patients studied, approximately 8 out of every 1,000 patients taking Spiriva had strokes while only 6 out of every 1,000 patients taking a placebo had strokes. In other words, the studies suggest that Spiriva may cause 2 out of every 1,000 patients taking the drug to have a stroke. 

Boehringer Ingelheim is expected to release additional data regarding the link between Spiriva and strokes from an extended 4 year study sometime in 2008. In the meantime, the FDA urges Spiriva patients to report Spiriva side effects, including strokes, to the FDA’s MedWatch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm.

JAMA Study Links Spiriva to Strokes, Heart Attacks, & Death

A study recently published in the Journal of the American Medical Association (JAMA), found that patients with chronic obstructive pulmonary disease (COPD) who took Spiriva for at least a month had a 58% higher risk of cardiac death, heart attacks, or strokes than those on a placebo or other medications. The findings were based on an analysis of 17 clinical trials involving 14,783 patients conducted by a research team led by Sonal Singh of the Wake Forest University School of Medicine in Winston-Salem.

Spiriva Side Effects Lawyers

If you or a loved one took Spiriva and suffered a serious side effect, such as a stroke or heart attack, you may be entitled to compensation for your injuries. Contact our experienced Spiriva side effects lawyers today for a free and confidential case evaluation.

Published November 17, 2011 by