Maryland Injury Lawyer Blog

Our lawyers are now investigating potential Spiriva HandiHaler lawsuits after the Journal of the American Medical Association, underscoring long held concerns, reported that Spiriva HandiHaler users may face increased risk of heart attacks or strokes and other cardiac problems.

The Spiriva HandiHaler (generic: tiotropium bromide inhalation powder) is an inhaler drug used by millions of people with emphysema and bronchitis. The Spiriva HandiHaler was approved in 2004. Along with its cousin Atrovent, which has been around for over 10 years, the Spiriva inhaler is used once or more daily to relax muscles and open airways in a patient’s lungs for patients with emphysema and chronic bronchitis (which are conditions under the umbrella of chronic obstructive pulmonary disease - COPD).

All indications are that both of these products – Spiriva and Atrovent - are efficacious for the purpose of opening the patient’s lungs and facilitating breathing. This new study, however, raised grave concerns that these inhalers could be associated with 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, with far reaching complications including strokes, heart attacks and death.

Stating the patently obvious, a 58% higher level of risk is unlikely to be the product of mere chance. This is particularly true with this JAMA study on Spiriva and Atrovent because this study looked at a number of studies, so the number of patients included in the analysis was large. Approximately 1.8% of the people on either Spiriva or Atrovent in the JAMA study developed fatal or nonfatal heart problems over a period of several weeks to several years. Patients on different drugs or a placebo have only a 1.2% risk.

Yet Boehringer Ingelheim, who manufactures the Spiriva and Atrovent inhalers, and Pfizer, who markets these inhalers, have done their own analysis just days after the JAMA study was released (coincidentally?) analyzing 30 clinical trials that suggest that the Spiriva inhaler does not increase cardiac risks.

To make matters more confusing, the FDA said back in a March MedWatch alert that using Boehringer Ingelheims’s own data from 29 studies of about 13,500 patients found that Spiriva is linked to an excess risk for strokes. Specifically, this data found that there was an excess risk of stroke for 8 patients of every 1,000 taking Spiriva for 1 year, compared to 6 patients of every 1,000 taking a placebo. This data is not as overwhelming as the 58% figure suggested by the JAMA study but it still is cause for concern.

There is no question that many patients with COPD need pharmacological assistance with their disease. Of the 24 million Americans with COPD, less than half are using medication to assist with their condition, which is one reason why we have 100,000 deaths a year in this country from COPD. And there appears to be no question that Spiriva is effective in fighting COPD. But our lawyers’ question is whether Spiriva's warning adequately informed patients of the increased risk of cardiac problems. Did they even modify their label after the FDA’s MedAlert earlier this year? Our lawyers also want to investigate whether Spiriva was properly tested for cardiac concerns, because there are other inhalers available that have not been linked to heart attacks and strokes.

Our lawyers believe there is enough information out there to begin evaluating Spiriva cases with an eye towards a potential class action lawsuit. If you would like to speak to a Spiriva lawyer, call 800-553-8082 or click here for a free Spiriva lawsuit consultation.