Spiriva Declared as Safe to Use for Lung Disease
FDA issued the statement Thursday, January 14, that the drug for chronic obstructive pulmonary disease (COPD) should be prescribed as normal as any other medicine. COPD is composed of chronic bronchitis and emphysema which usually co-exist as lung disease.
Spiriva was developed by German drugmaker Boehringer Ingelheim and co-marketed in the United States by Pfizer.
The review used a company-sponsored study that involved 6,000 patients. A panel created by FDA involving external experts approved the safety claims of Spiriva. FDA began investigations of the drug last March after Boehringer reported slightly higher rates of stroke and heart attacks for patients who used the device when compared to those who used placebo.
“This reaffirms the well-established safety profile of Spiriva HandiHaler,” Pfizer said.