NeLM news service
FDA panel supports new labelling about benefits of tiotropium (Spiriva®) and confirms safety

Source: PharmaLive

Date published: 20/11/2009 16:20

Summary
by: Yuet Wan

Following a submission to the FDA by Boehringer of studies showing that tiotropium (Spiriva®) reduces specific side effects of chronic obstructive pulmonary disease (COPD), such as coughing, wheezing and shortness of breath, the Agency’s panel of lung specialists has voted 11-1 in favour of the new labelling about the benefits of this treatment.  The FDA also asked its panel to examine conflicting evidence about whether the drug increases the risk of heart attack, stroke and death following analysis of multiple studies published in JAMA suggesting these increased risks. Panelists said a more definitive, 6000-patient trial by the company did not show increased death, and suggested it can actually reduce that risk. Panelists voted 11-1 that the company's study did not show evidence of increased stroke, and 11-0, with one abstention, that there was no increased risk of heart attack.

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