NEW YORK (AP) – An analysis in a British medical publication said patients who took a version of lung drug Spiriva in clinical trials were 52 percent more likely to die than patients who took a placebo.
The drug is made by German drugmaker Boehringer Ingelheim, which markets it in the U.S. with Pfizer Inc. of New York.
The article in The British Medical Journal contained an analysis of five clinical trials of the “mist” version of Spiriva, which is sold in Europe under the name Respimat, but is not approved in the U.S. It found the drug was associated with greater risk of death. The authors found one additional death for every 124 patients who took 5 milligram-doses of Spiriva once a day for a year.
Spiriva, or tiotropium, is used as a once-per-day treatment for breathing problems associated with the chronic obstructive pulmonary disease, or COPD, which includes chronic bronchitis and emphysema. It is also used to treat asthma in some patients who do not respond to steroids.
The Food and Drug Administration approved the dry powder version of Spiriva in January 2004, and the drug’s safety has come into question before. In 2008, the Journal of the American Medical Association published an analysis of multiple studies that suggested increased risks with the inhaler. But in 2009, FDA panelists said a more definitive, 6,000-patient trial by Pfizer did not show increased death, and suggested it can actually reduce that risk.
Date: June 15, 2011
Source: Associated Press
Filed Under: Drug Discovery
