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Spiriva FDA Alerts

The FDA Alerts below may be specifically about Spiriva or relate to a group or class of drugs which include Spiriva.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Spiriva

Tiotropium (marketed as Spiriva HandiHaler)

[UPDATE 10/07/2008] FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo. 

Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.

FDA expects to receive the complete report for UPLIFT in November 2008.  Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.

[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 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 Spiriva, 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 Spiriva is 2 patients for each 1000 patients using Spiriva 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 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. 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.

[UPDATE October 07, 2008 - Early Communication about an Ongoing Safety Review - FDA]

Tiotropium (marketed as Spiriva HandiHaler)

[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 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 Spiriva, 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 Spiriva is 2 patients for each 1000 patients using Spiriva 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 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. 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.

[March 18, 2008 - Early Communication about an Ongoing Safety Review - FDA]

Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) Capsules

[Posted 02/29/2008] FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil 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 Spiriva and Foradil 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.


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