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

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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.

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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.

Tags: COPD, HandiHaler, Inhaler, Spiriva
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2 Comments

Yvette
I was diagnosed with COPD 14 years ago I first was taking ipratropium in nebulizer for 8 years, I started with Spiriva handihaler in July 2004. my condition is getting worse, wheezin, shortness of breath, I must take ozygen several times a day, I am under a Pulmonologist care, I asked if I should stop spiriva, I must take more tests to determine outcome, I was hospitalized twice at the start of Spiriva.I have emphysema,How dangerous is Spiriva at this time?
Tracy
What about lung cancer? My mom had been doing great-even with her COPD once she started using this product, then 1-1/2yrs into it, lung cancer…out of the blue. Sure, people could say she got it from having smoked (quit 9 yrs. earlier), but the doc’s seem to think it started to grow just about the same time she started using spiriva…I find it rather interesting-the timing.

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