Product Liability

Study links COPD inhaler to 52 percent increased risk of death

A mist inhaler with the drug Spiriva has been shown to increase the risk of death by 52 percent in people with chronic obstructive pulmonary disease (COPD), according to a new review. The mist inhaler, called Respimat, which contains the drug Spiriva (tiotropium), is approved in 55 countries, but not yet in the United States. Spirivia is approved in the U.S. for COPD in a powdered form delivered with a “Handihaler,” which was  not included in the review.

The new study, led by Dr. Sonal Signh, an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine in Baltimore, analyzed data from five published studies that included a total of more than 6,500 patients. The mist inhaler of Spiriva was compared to a mist inhaler with a placebo.

The data showed that patients who used the inhaler with Spiriva were 52 percent more likely to die than those who used the inhaler with the placebo. Cardiovascular disease was the main reason for the increased risk of death. Researchers surmised that the deaths may be a result of the mist inhaler delivering a higher concentration of tiotropium than it should have. Both tiotropium and COPD put patients at increased risk for cardiovascular events.

Researchers say that American patients should not be alarmed nor should they stop current treatment with the powdered form of Spirivia with the Handihaler device, but the data does give regulators something to consider when reviewing the mist inhaler version of the drug for approval in the U.S. COPD patients are advised discuss the risks and benefits of their COPD treatment with their doctors.

COPD, which includes emphysema and bronchitis, is the fourth leading cause of death worldwide. It is commonly associated with long-term cigarette smoking.

Source: US News