FDA Says Leading COPD Drug Won’t Harm Heart

The U.S. Food and Drug Administration (FDA) has concluded that there is no good evidence supporting the claims that the Spiriva HandiHaler boosts heart risks in patients who use it to help control chronic obstructive pulmonary disease (COPD). These findings refute earlier research which suggested that the use of tiotropium (Spiriva), the medicine’s active ingredient, was responsible for an increased risk of stroke in patients being treated with the drug.

The FDA findings should come as a relief to those patients who rely on the Spiriva HandiHaler, which is one of the most commonly prescribed daily treatments for COPD. In its statement, the FDA said its review of the data does “not support an increased risk of stroke, heart attack, or death in patients using the medicine.”

The safety of another drug in the same class as Spiriva (anticholinergics), the widely used Atrovent (ipratropium bromide), still remains unclear. Research released in January suggests that the drug raises patients’ risk for heart attack and heart failure.

"The short-acting form [Atrovent] seems to increase cardiovascular risk, while the long-acting form [Spiriva] seems to decrease it," said Dr. Norman H. Edelman, chief medical officer of the American Lung Association. "It is important to point out, however, that the difference is an indirect inference."

Dr.Edelman believes that to prove beyond a scientific doubt that the two forms of drugs are different in this or other ways, a head-to-head comparison study will have to be conducted -- something he does not believe is likely to be done.