Spiriva HandiHaler Linked with Stroke Risk

German pharmaceutical developer Boehringer Ingelheim is taking part in an FDA safety review following reports linking the company’s Spiriva respiratory inhaler (HandiHaler) with increased risk of stroke. Boehringer submitted internal data to the FDA comparing Spiriva patients with those using a placebo. Those using the Spiriva inhaler faced a higher instance of stroke than those using a placebo.

The Spiriva respiratory inhaler is an FDA-approved treatment for patients suffering from chronic obstructive pulmonary disease, the fourth most common cause of death in the United States. Although the HandiHaler was developed by Boehringer Ingelheim, it is marketed by both Boehringer and Pfizer Inc.

Spiriva Stroke Risk

The FDA warning regarding increased stroke risk associated with use of the Spiriva respiratory drug follows results of 29 patient studies conducted over the course of several years. Based on the preliminary results returned from these Boehringer studies, 2 out of every 1,000 patients using Spiriva suffers a stroke.

Additional Boehringer data from an extended four-year study is expected to be released sometime in June 2008. This study is expected to yield more comprehensive safety information. The FDA is urging caution for patients using Spiriva and suggesting they speak with their physician about determining their best course of action. Spiriva has proven effective in the management of obstructive pulmonary disease. Patients should not discontinue use without first consulting their doctor.

Spiriva Lawsuits

Boehringer Ingelheim is responsible for ensuring the safety and efficacy of its products before marketing them to the public. Failure to inform patients of all potential risks associated with the use of a drug is considered negligent and can be grounds for personal injury litigation. If you or a loved one has been injured as a result of using Boehringer Ingelheim’s Spiriva respiratory drug, you may be entitled to receive compensation to offset medical bills, loss of work, pain and suffering, etc.

The Law Offices of Aylstock, Witkin, Kreis and Overholtz boast some of the most experienced personal injury lawyers Pensacola, Florida has to offer. Contact AWKO Law today at (888) 255 2956 to get additional information regarding your rights as a Spiriva injury victim.