Information About the Drug Spiriva Being Linked to Increased Risk of Strokes, Heart Attacks and Cardiovascular Deaths

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A new JAMA article reports on a study allegedly showing that the blockbuster drug Spiriva HandiHaler may cause higher incidents of heart attacks, strokes and cardiovacsular deaths than a placebo population. The FDA issued an early warning communication in March 2008 identifying similar dangers. The drug companies that distribute Spiriva dispute the findings. The issue is likely to be hotly debated in the coming months.

Bernstein Liebhard & Lifshitz, LLP, a law firm named to the prestigious National Law Journal's Plaintiffs' Hot List for the past five years, announced today that it has added content to its website that provides consumers with information about an FDA communication and a recent Journal of the American Medical Association (JAMA) article reporting on strokes, heart attacks and cardiovascular deaths in patient populations using Consumer Injury Lawyers | Spiriva Dangerous Side Effects Information.

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.

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.

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.

For More Information Contact:
Bernstein Liebhard & Lifshitz, LLP
10 East 40th Street
New York, New York 10016
(877) 779-1414

or visit | Spiriva Dangerous Product Alert

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