Last month, we told you about a study that linked Atrovent and Spiriva [1] to an increased risk of heart attack and stroke. German drugmaker Boehringer Ingelheim is now refuting the findings, which the well respected Annals of Internal Medicine and Journal of the American Medical Association published.
In fact, the FDA says that Boehringer presented new data showing that there is no increased stroke risk for patients using the inhaler drug. Pfizer markets the medications in partnership with Boehringer [2] in the U.S. to help relieve the symptoms of chronic obstructive pulmonary disease (COPD [3]).
The new data comes from a study of 6,000 patients (monitored over the course of four years) that compared Spiriva to a placebo medication. While the results are preliminary, the FDA plans to update the public after receiving final study results next month, although it could be several months before the FDA will have its full review completed.
--read the story [4] at Business Week
--here's the FDA safety summary [5]
Related Articles:
Studies link lung meds to stroke, death [6]
Boehringer warns of inhaler's stroke risk [7]
Study shows Glaxo drug outpacing Pfizer's Spiriva [8]
Spiriva offers no advantage over inhaled placebo [9]
Links:
[1] http://www.fiercepharma.com/story/studies-link-top-lung-meds-heart-attack-stroke-death/2008-09-24?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FP0
[2] http://www.fiercepharma.com/special-reports/boehringer-ingelheim-top-13-advertising-budgets
[3] http://www.fiercebiotech.com/tags/copd
[4] http://www.businessweek.com/ap/financialnews/D93LQK1G0.htm
[5] http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium
[6] http://www.fiercepharma.com/story/studies-link-top-lung-meds-heart-attack-stroke-death/2008-09-24
[7] http://www.fiercepharma.com/story/also-noted-gsk-faces-tyverb-setback-over-safety-boehringer-warns-of-inhaler/2008-03-19?utm_medium=rss&utm_source=pharma_Ceftobiprole&cmp-id=OTC-RSS-FP0
[8] http://www.fiercepharma.com/story/also-noted-sepracor-chair-retire-may-study-shows-glaxo-drug-outpacing-pfizers-spiriva/2008-01-
[9] http://www.fiercepharma.com/story/remicade-boosts-crohns-drug-regimen-perrigo-buys-mexican-drugmaker-25m/2008-10-06