Special Alerts:

[Posted 03/18/2008] Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take tiotropium bromide (Spiriva). This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with tiotropium bromide, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to tiotropium bromide is 2 patients for each 1000 patients using tiotropium bromide over a one year period.

It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between tiotropium bromide 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. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium and http://www.fda.gov/cder/drug/early_comm/tiotropium.htm.

[Posted 02/29/2008] FDA informed healthcare professionals and consumers of the correct way to use tiotropium bromide (Spiriva HandiHaler) and formoterol fumarate (Foradil Aerolizer) inhalation powder capsules. FDA and the American Association of Poison Control Center’s (AAPCC) National Poison Data System have received many reports of patients swallowing tiotropium and formoterol capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public Health Advisory for important information on the correct use of both products. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Spiriva and http://www.fda.gov/cder/drug/advisory/tiopropium_formoterol.htm.