Can the COPD Drug Spiriva Increase Your Stroke Risk?

The FDA once warned that it could, then backtracked

The U.S. Food and Drug Administration issued a warning in 2008 stating that there was some preliminary evidence that Spiriva could raise stroke risk, and possibly also the risk of heart attack or death. However, the agency retracted the warning in 2010, stating that evidence showed that Spiriva didn't increase those risks.

Spiriva on a black background
RonEJ at English Wikipedia / Wikimedia Commons / Public Domain

The available evidence from the most recent clinical trials indicates that Spiriva does not increase the risk of stroke, heart attack, or death.

Spiriva is a treatment for bronchospasms that occur as part of COPD. These are sudden contractions in the airways that make it difficult to breathe. The medication is taken once daily through an inhaler to prevent bronchospasm. It's not intended to be used as a "rescue medication" to stop symptoms.

The original FDA warning on Spiriva, issued on March 18, 2008, raised questions about the drug because an analysis of preliminary safety data from 29 clinical trials involving Spiriva indicated that more people with COPD taking Spiriva had strokes than people taking an inactive placebo.

Specifically, the preliminary data showed that eight out of every 1,000 people taking Spiriva had a stroke, compared to six out of every 1,000 people taking the placebo. The FDA acknowledged that the information was preliminary, and wanted to alert healthcare providers and patients about it.

Based on the preliminary data, the FDA asked Spiriva's manufacturer, Boehringer Ingelheim Pharmaceuticals, Inc., to go back and study the issue again. The federal agency also told those who had been prescribed Spiriva not to stop taking the drug, and to discuss any concerns they had with their healthcare providers.

More Detailed Review of Spiriva Didn't Show Problem

Once FDA officials and their counterparts at Boehringer Ingelheim had reviewed all the data collected on Spiriva, on Jan. 14, 2010, the FDA retracted its 2008 safety warning on the medication.


"FDA has now completed its review and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk of these serious adverse events. FDA is advising healthcare professionals to continue to prescribe Spiriva HandiHaler as recommended in the drug label."

Spiriva Side Effects

Spiriva, which now is sold in two versions — Spiriva HandiHaler and Spiriva Respimat — does have the potential for side effects, some of which may be serious.

The most common side effects with Spiriva include upper respiratory infections, sinus infections, non-specific chest pain, urinary tract infection, dry mouth, stuffy nose, indigestion, and sore throat. Dizziness or blurred vision may also occur with Spiriva, which may mean you need to use caution driving or operating machinery.

In addition, Spiriva can increase pressure in your eyes, leading to acute narrow-angle glaucoma, a condition that can threaten your vision. If you use Spiriva and have eye pain, blurred vision, reddened eyes, or if you start seeing halos around lights, call your healthcare provider immediately.

Finally, Spiriva can cause you to have difficulty passing urine and painful urination. If this happens to you, stop taking the medication and call your healthcare provider.

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3 Sources
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  1. Major JM, Zhou EH, Ding Y, Ly T, Li J, Pinheiro SP, Seymour S. The effect of FDA drug safety communications on patterns of Tiotropium dispensing: A U.S. health plan claims database study. J Manag Care Spec Pharm. 2018 Jul;24(7):700-709. doi:10.18553/jmcp.2018.24.7.700

  2. Michele TM, Pinheiro S, Iyasu S. The safety of tiotropium--the FDA's conclusions. N Engl J Med. 2010 Sep 16;363(12):1097-9. doi:10.1056/NEJMp1008502

  3. Food and Drug Administration. Spiriva Respimat label. 2019

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