The Journal of the American Medical Association reports that Spiriva HandiHaler patients may face increased risk of heart attacks or strokes and other cardiac problems.
The Spiriva HandiHaler (generic: tiotropium bromide inhalation powder) is an inhaler for long-term treatment of bronchospasm linked with chronic obstructive pulmonary disease (COPD). This disease is commonly described as emphysema and chronic bronchitis.
On the market for about four years, the Spiriva Handihaler is made by Boehringer Ingelheim. Pfizer also markets the Spiriva Handihaler. Boehringer also makes Atrovent, (generic name: Ipratropium bromide inhaler). The Atrovent inhaler has been around for about 10 years. Over five million people use these two inhalers. The Spiriva inhaler and Atrovent work the same: it opens pathways for effective breathing and preventing spasms that narrow airways in the lungs.
These inhalers have served that purpose, by all accountsm and that Spiriva is generally well tolerated by patients with few side effects. But this recent JAMA study shows that these inhalers could be linked to these potentially fatal cardiac conditions. The study looked at other drug trials and found that people taking Spiriva or Atrovent had a 58% higher risk of developing cardiac problems, including fatal heart attacks and strokes. Stating the obvious, if Spiriva has few side effects but one of those side effects is heart disease, that is a pretty big side effect we ought to be talking about.
This is not the first indication of concern with the Spiriva inhaler. In March 2008, the FDA raised concerns about the possible connection between the side effects of Spiriva Handihaler and an increased risk of strokes.
There is no question that COPD is a serious disease. A slowly progressive airway disease that causes significant deterioration of lung function and chronic breathlessness, COPD can cause severe disability. Incredibly, although there is not a lot of media attention around COPD, it is the fourth leading cause of death in the world. While it is great that Spiriva is efficacious for COPD, our lawyers question is whether Spiriva’s warning adequately informed patients of the increased risk of cardiac problems, whether Spiriva was properly tested for cardiac concerns and whether there are other safer drugs available with the same cardiac risks. Regarding the latter point, the question is not whether patients would be better off not taking any medication for COPD, which is notoriously an undertreated disease, but whether there are safer inhalers than Spiriva (and Atrovent) available.
While we are still learning more about the cardiac risks associated with Spiriva, our lawyers believe there is enough evidence to begin evaluating Spiriva lawsuits. If you would like to speak to a Spiriva lawyer, call 800-553-8082.