Boehringer Reports Their Inhaler Increases Stroke Risk
March 19, 2008
Boston (dbTechno) - Boehringer Ingelheim has come out and informed the FDA that their respiratory inhaler, Spiriva Handihaler, may increase the risk of stroke in those who use it.
Drug manufacturer submitted the details to the FDA, who came out on Tuesday and revealed the information to the public.
The U.S. Food and Drug Administration stated that the data submitted by the drug manufacturer shows a slightly higher rate of stroke for patients who use their inhaler, Spiriva Handihaler.
The increased stroke risk was compared to patients who used a placebo.
The inhaler is used to treat chronic obstructive lung diseases. These include things such as chronic bronchitis.
The German drug manufacturer submitted the data to the FDA based off of 29 patient studies.
The data stated that 2 out of every 1,000 patients using the inhaler are at risk of stroke.
Further safety data will be released in June, with the FDA stating that doctors and patients should report any type of side effects from the use of the inhaler.
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