Spiriva May Increase Risk of Stroke
Article posted on: 04/16/2008 (subsequent reports in 2010 contradict this article)
According to U.S. regulators’ recent reports, the respiratory medicine Spiriva HandiHaler may increase the risk of stroke. As noted on Bloomberg.com, the Food and Drug Administration (FDA) published a notice indicating that Spiriva was associated with two more cases of stroke in every 1,000 patients treated for one year compared with a placebo medicine in a pooled analysis of 13,500 patients. Spiriva is marketed by Boehringer, the world’s largest family owned drugmaker with Pfizer Inc., as a once-a-day inhaled treatment for breathing difficulty caused by chronic obstructive pulmonary disease. The Ingelheim, Germany-based company is assessing the long-term effects of the drug in a four- year study that is expected to report results in June, the FDA said. At that point, the FDA will review the report and make conclusions and recommendations to the public.
Subsequent to the release of these reports, in 2010, the FDA reversed its course, stating that the available data did not support an association between the Handihaler and increased risk of adverse events, i.e., stroke / heart attack. In fact, some recent studies have suggested that Spiriva might actually lower patients’ risk of heart problems and death. This is certainly good news for the medication’s manufacturers and product distributors given the world wide usage of the drug.
Spiriva is prominently used by individuals who have developed COPD (chronic obstructive pulmonary disease). COPD generally is experienced in older adults or those who have chronic respiratory disease or individuals with a long history of smoking. Common side effects include dry mouth, constipation, sudden worsening of breathing problems right after use. Although serious allergic reactions are rare, some people have developed dizziness, blurred vision, eye pain, swelling of face / tongue / throat and trouble breathing. Older adults may be more sensitive to the side effects of the drug, including the dry mouth and constipation.
If you or a loved one believe that you have suffered an injury as a result of Spiriva Handihaler or experienced a serious side effect that has caused you permanent injury, call the lawyers at Silverman Thompson for a free consultation at (410) 385-2225 or visit our website to set up your free consultation with a member of our team. Our attorneys regularly handle these types of cases on a contingency basis, meaning that our firm lays out the expenses in advance and our clients are only required to reimburse us if the case is successful via a settlement or at trial or on appeal.
Our office routinely handles medical malpractice / medical negligence / medical error cases and matters in the Baltimore and Washington D.C. metropolitan areas against physicians and hospitals including Johns Hopkins Hospital, University of Maryland Medical System, St. Joseph’s Hospital, Union Memorial Hospital, Bon Secours Hospital, St. Agnes Hospital, Sinai Hospital, Upper Chesapeake Medical Center, Anne Arundel County Medical Center, Howard County General Hospital, Frederick Memorial Hospital, Baltimore Washington Medical Center, Shady Grove Adventist Hospital, and Washington Adventist Hospital.