JAMA article reports on a study allegedly showing that the COPD drug Spiriva called the HandiHaler may cause higher incidents of heart attacks, strokes and cardiovacsular deaths to COPD users. The inhaled lung medication Spiriva, marketed by Pfizer Inc and Boehringer Ingelheim, increases the risk of heart attack, stroke and death from heart disease according to researchers. People who took Spiriva or Boehringer's older medication, Atrovent, for at least a month were 58 percent more likely to experience heart attack, stroke or cardiovascular death than those taking other drugs, the U.S. researchers wrote in the Journal of the American Medical Association (JAMA)
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.
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 Warning - Spiriva HandiHaler
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 FDA 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.
Spiriva Inhaler Study
A new study conducted by researchers at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., 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.
Spiriva Heart Attack, Stroke & Death Lawsuits |
