Spiriva HandiHaler Linked with Stroke and Heart Attack Risk

Boehringer Ingelheim, German pharmaceutical manufacturer’s Spiriva inhaler (HandiHaler) is under a FDA safety review following reports that the Spiriva inhaler (HandiHaler) users may have an increased risk of stroke or heart attack. Complying with the review, Boehringer has presented data to the Food and Drug Administration that compares patients using Spiriva inhaler to patients using a placebo. According to recent reports, more patients on the Spiriva inhaler suffered strokes over patients using the inhaler that was a placebo. The FDA approved the Spiriva inhaler for treating patients with chronic obstructive pulmonary disease. It is important to note that COPD is a serious disease and is the fourth most common cause of death in the United States. Pharmaceutical giants Boehringer and Pfizer Inc. jointly market the HandiHaler in the United States.

Increased Stroke Risk linked to Spiriva HandiHaler use
In March 2008, The FDA issued a warning regarding the increased stroke risk to users of the respiratory drug, Spiriva HandiHaler.  Documents from the manufacturer,  Boehringer showed patients using Spiriva to suffer strokes at a rate of 2 out of 1,000. However, the Food and Drug Administration urged patients using Spiriva to not be alarmed and recommended patients on the drug to seek medical attention from their physician to determine whether they should stop taking the drug. Over the years, Spiriva has shown to be effective in treating COPD. Concerned patients should not stop using the Handihaler without discussing this with their physician.

Increased Heart Attack Risk linked to Spiriva HandiHaler use
The Journal of the American Medical Association  published a research article written by Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD entitled “Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease”. The research article discussed patients using the Spiriva inhaler and the possible increased risks of cardiac death, heart attacks or strokes. However, it is important to note that the drug is not specifically known to affect the heart; therefore, more research must go into this before a concrete link is determined. In previous studies, the Spiriva Handihaler (tiotropium) and Atrovent (ipratropium) have shown to have adverse effects, but none linked to cardia death. The validity of the independent study by Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD was questioned by the manufacturer because of the past success the drug has shown in providing treatment for COPD.

Lawsuits for Spiriva HandiHaler
It is imperative that pharmaceutical manufacturers are accountable for maintaining safety standards and ensuring efficacy for products before marketing them to the public. Failure in ensuring safety and efficacy is negligent and the foundation for personal injury litigation involving product liability. The Attorneys of LaBovick & Labovick, P.A. are experienced personal injury attorneys in Florida. Since 1992, LaBovick & LaBovick, P.A. has represented a number of individuals and obtained successful compensation for personal injury litigation. Call LaBovick & LaBovick, P.A. toll free at 888-777-3884 for more information about your rights. The firm represents the seriously injured in personal injury related matters including, wrongful death, defective drugs, and workers compensation.