Spiriva Mist Inhaler Side Effects May Increase Risk of Death: Study

Potential side effects of Spiriva mist inhalers, which are not yet approved for sale in the United States, could increase the risk of death by more than 50%, according to a new study by Johns Hopkins researchers. 

The Spiriva mist inhalers are sold in 55 countries around the world, including the U.K., but they are still awaiting approval here in the United States, where only the Spiriva handihaler is approved for use. The handihaler delivers the drug in powdered form.

According to a study published last week by the British Medical Journal, the risk of death was much higher with the Spiriva mist inhalers, known as the Respimat device.

Researchers looked at about 6,500 patients who participated in five different studies. They found that those using the Spiriva Respimat inhaler had a 52% increased risk of death over those given an inhaler with a placebo. The most common cause of death was cardiovascular disease.

While the researchers theorize that the mist inhaler may be delivering the drugs in concentrations that are too high, the manufacturers, Pfizer and Boehringer Ingelheim have rejected the study’s findings, indicating that they have access to more detailed patient data than the researchers and have found there to be no threat.

The findings come about a year and a half after the FDA investigated the Spiriva Handihaler because it too was suspected of increasing the risk of death, stroke and heart attack. However, in January 2010, the FDA concluded that there was no link between the Spiriva Handihaler and an increased risk of death.

Spiriva (tiotropium) is a medication used for the long-term maintenance treatment of bronchospasm linked to chronic pulmonary obstructive disease (COPD). Since the Handihaler was approved by the FDA in 2004, it has grown to dominate the market for COPD inhalers and has been used by millions of Americans.