Drugs Xagena
The FDA ( Food and Drug Administration ) issued a Follow-Up to the previous Early Communications issued in 2008, describing a potential increase in the risk of stroke, myocardial infarction, or death from a cardiovascular cause related to the use of Tiotropium, which is marketed as Spiriva HandiHaler.
FDA has now completed its review and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events.
FDA is advising healthcare professionals to continue to prescribe Spiriva HandiHaler as recommended in the drug label.
In 2008, FDA informed healthcare professionals that FDA had 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 publications reported increased risk for mortality and/or cardiovascular events in patients who received Tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.
In 2008, Boehringer Ingelheim and FDA notified healthcare professionals that safety monitoring had identified a possible increased risk of stroke in patients who take Spiriva.
Boehringer Ingelheim reported to the FDA that it 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 were 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 was 2 patients for each 1000 patients using Spiriva over a one year period. ( Xagena )
Source: FDA, 2010
XagenaMedicine_2010
