FDA: Spiriva Linked to Possible Stroke Risk
But more data are needed before the agency can accurately assess risk and issue recommendations
THURSDAY, March 20 (HealthDay News) -- Preliminary data suggests that patients with chronic obstructive pulmonary disease who use the Spiriva HandiHaler may have an increased risk of stroke, but the evidence is not strong enough to show a causal relationship, according to an Early Communication issued this week by the U.S. Food and Drug Administration. Until further information is available, the agency is not advising health care professionals to discontinue prescribing the drug or contemplating any regulatory action.
The communication was prompted by a pooled analysis of 29 placebo-controlled clinical studies involving about 13,500 patients, which was conducted by the drug's manufacturer, Boehringer Ingelheim. The analysis suggests that the stroke risk over one year may be higher among patients using Spiriva than among patients using placebo (eight versus six per 1,000 patients).
The agency is reviewing post-marketing adverse event reports associated with Spiriva and is collaborating with Boehringer Ingelheim to assess the potential risk of stroke. The manufacturer has conducted a large-scale, four-year study: UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium). When the results are released in June 2008, the agency plans to analyze the data and issue its conclusions and recommendations.
"It is important to interpret these preliminary results with caution," the FDA stated. "FDA has not confirmed these analyses. Pooled analyses can provide early information about potential safety issues. However, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. This early communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs."