Spiriva Handihaler May Increase Risk of Heart Attacks, Stroke or Death

According to research published today in the Journal of the American Medical Association, those using the Spiriva Handihaler or an older generic inhaler called ipratropium, could face an increased risk of cardiac death, heart attacks or strokes when compared with those who received a placebo or other drugs.

Spiriva Handihaler (tiotropium) is an inhaled medication made by Boehringer Ingelheim Pharmaceuticals Inc. and jointly marketed by Boehringer and Pfizer Inc. in the U.S. It was approved in 2004 as a once-daily long-term treatment of bronchospasm linked with chronic obstructive pulmonary disease (COPD).

Ipratropium is the generic name for Atrovent, which is also manufactured by Boehringer. It was approved in 1998 for treatment of COPD.

Both medications are anti-cholinergics that work by opening passages for effective breathing and preventing spasms that narrow airways in the lungs. They have been used by a combined 8 million people worldwide.

A new study published in the September 24, 2008 issue of JAMA suggests that although the risks were small, the popular inhalers could be linked to serious and potentially life threatening side effects.

Researchers analyzed data from 17 randomized studies, comparing mainly older people on either drug to those on placebos or other drugs. It was found that patients on Spiriva or ipratropium had a 58% higher risk of developing heart problems, both fatal and nonfatal, including heart attacks.

Out of 7,400 patients using Spiriva Handihaler or ipratropium, 1.8% developed heart problems, compared with 1.2% of the 7,300 users who received other drugs or placebos. This could mean that one extra drug-linked death could be caused by ipratropium and Spiriva side effects for every 40 patients using either of the two drugs for one year.

Researchers indicate that additional studies are necessary to fully evaluate the safety of the drugs. However, they did suggest that individuals with COPD should try to reduce heart risks by stopping smoking, controlling blood pressure and cholesterol and using oxygen before starting drug therapy.

Boehringer and Pfizer have released a statement that they strongly disagree with the analysis of the new study. They indicate that an analysis of 30 clinical trials confirmed that Spiriva Handihaler is safe to use and that there is no increased risk of all-cause death or cardiovascular death

In March 2008, the FDA issued an early communication indicating that they are evaluating a possible connection between side effects of Spiriva Handihaler and an increased risk of strokes. At that time, the drug regulator agency indicated that their investigation does not mean that there is a causal relationship between Spiriva and strokes, and that individuals should not stop taking their drug based on their early communication.

The FDA has not updated their early communication from March, which indicated that the would announce any conclusions and recommendations to the public later this year.