CHICAGO, June 15 Reuters - A mist inhaler used to improve breathing in people with lung diseases including chronic bronchitis and emphysema may increase their risk of dying by 52 percent, U. It delivers a soluble form of Spiriva, known generically as tiotropium. The finding was contested by Pfizer and BI. The inhaler is used to treat chronic obstructive pulmonary disease, or COPD, the fourth-leading cause of death worldwide, which includes the chronic lung diseases emphysema and bronchitis.
COPD is usually due to decades of smoking. The inhaler is approved for use in Britain and Europe, but failed to win a nod from the U. Food and Drug Administration, which noted an excess number of deaths in a study of 17, patients. Instead, the FDA said it wanted more proof the inhaler was safe. The new study, published in the British Medical Journal BMJ , is based on an analysis of data from five clinical trials involving 6, people.
It found that the risk of death in patients using the tiotropium Respimat inhaler was 52 percent higher than patients who used a placebo. He said some of the added risk stems from patients dying of heart trouble, especially for those with existing heart problems that may be made worse with use of the product. The drugmakers added that all the studies included in the pooled analysis had been published and already shared with European regulatory authorities.
L rival product Advair. That might offset the looming threat of generic competition to Advair in non-U. A copycat version of Advair was recently approved in Sweden. Most COPD sufferers use inhalers to help them breathe and more than half a million prescriptions for tiotropium inhalers were issued in Britain last year. By 4 Min Read.
