FDA warns of stroke risk with Spiriva.Boehringer Ingelheim and FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. issued an Early Communication to notify health care professionals that ongoing safety monitoring Safety Monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution. has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide bromide, any of a group of compounds that contain bromine and a more electropositive element or radical. Bromides are formed by the reaction of bromine or a bromide with another substance; they are widely distributed in nature. and is used to treat bronchospasm bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma. bron·cho·spasm n. associated with chronic obstructive pulmonary disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. . Boehringer Ingelheim reported to FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies. Based on data from these studies, the preliminary estimates of the risk of stroke are eight patients per 1,000 patients treated for one year with Spiriva, and six patients per 1,000 patients treated for one year with placebo. FDA stated, "It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources." Read the complete MedWatch 2008 safety summary, including a link to the Early Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium |
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