Spiriva HandiHaler Linked with Stroke, Heart Attack 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 Heart Attack Risk
A new study published in the Journal of the American Medical Association has revealed a link between the use of certain inhaler lung drugs and an increased risk of heart attack and death.
The results from 17 randomized studies evaluated older patients using either inhaler lung drug with patients using alternative or “dummy” drugs. The study found that approximately 1.8 percent of patients taking Spiriva or Atrovent developed cardiac problems; this compared with 1.2 percent of those using alternative medications or placebos who also developed cardiac problems. The drugs are not known to affect the heart, calling into question the validity of the results. Experts continue to evaluate the drugs to determine the exact nature of the link between use and cardiac problems.
Boehringer Ingelheim Pharmaceuticals’ Spiriva Handihaler (tiotropium) and Atrovent (ipratropium) have previously been linked with other adverse effects; however, many experts question the seriousness of the newfound link with cardiac death. Boehringer has questioned the validity of the study, stressing the effectiveness of the anti-cholinergic drugs in providing treatment for COPD, the fourth leading cause of death in the United States.
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for pharmaceutical litigation. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. Contact AWKO law today at (844) 794-7402 to get more information about your rights as a Spiriva injury victim.