JAMA Article Reports Findings of Dramatic Risk of Heart Attack, Stroke and Cardiovascular Death in Patients Who Take Spiriva
September 24, 2008 – A new study conducted by researchers at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. and published in the Journal of the American Medical Assocation (JAMA), found that using either Spiriva or Atrovent, which are both inhaled anticholinergic drugs used to treat the lung condition chronic obstructive pulmonary disease (COPD), for a month increased a patient’s risk of cardiovascular death, heart attack or stroke by 58 percent. Tiotropium bromide is the ingredient believed to cause the side effects.
What is Spiriva HandiHaler?
Spiriva treats bronchospasm (narrowing of the airways in the lungs) associated with chronic obstructive pulmonary disease (COPD). It is an anticholinergic agent. It works by enlarging the airways to allow easier breathing. It comes as a capsule containing dry powder, which is inhaled through the mouth using the HandiHaler device. Sprivia is manufactured by Boehringer Ingelheim, a German based pharmaceutical company, and marketed by Pfizer.
COPD is a progressive lung disease that affects as many as 24 million Americans and kills more than 100,000 each year. Symptoms of COPD include restricted breathing, secretion of mucus, oxidative stress and inflammation of the airways. Spiriva is the most widely prescript drug to treat COPD. It has been used by more than 8 million patients around the world since it was approved by the Food and Drug Administration (FDA) in 2002.
FDA Early Warning Communication
In March 2008, the FDA issued an early warning communication about a possible connection between Spiriva HandiHaler and an increased risk of stroke. The FDA drug regulators indicated that they are reviewing information about Spiriva side effects, and will announce any conclusions and recommendations to the public later this year after data from a four year study has been received and analyzed.
According to the letter, pooled results from 39 different clinical trials, individuals treated with Spiriva for one year may face an increased risk of certain side effects, including strokes. Data has been reviewed for 13, 500 individuals with COPD who were treated with Spiriva HandiHaler or Spiriva Respimat, which is another formulation of Spiriva approved for use in Europe. Preliminary estimates indicated that approximately 8 out of every 1,000 individuals treated with Spiriva for one year suffered a stroke side effect, compared with 6 out of every 1,000 who suffered a stroke while taking a placebo.
The FDA has indicated that individuals should not stop taking Spiriva HandiHaler based on the early communication and they should contact their doctors with any questions about this new information. Doctors and patients have been urged to report any Spiriva HandiHaler side effects by calling (800) 332-1088 or online at FDA Medwatch.
If you, a friend or family member has suffered a stroke, heart attack or cardiovascular death while using Spiriva, contact our Spiriva trial lawyers today for a confidential and free case evaluation.