Spiriva

On March 18, the FDA released information on the safety of tiotropium bromide better known as Spiriva. Spiriva HandiHaler, manufactured by Boehringer Ingelheim, is used to treat bronchospasm in people with chronic obstructive pulmonary disease (COPD). However, recent analysis of studies and safety reports from patients taking the drug show a risk of stroke. Spiriva's safety concerns were reported to the FDA by its manufacturer as a possible risk of stroke in patients taking the drug for over a one year period.

COPD is a disease associated with smoking which irritates the airways and affects the stretch ability of the lungs. It is usually a cross between chronic bronchitis and emphysema. In chronic bronchitis the lungs get inflamed and produce excess amount of mucus that narrow or block the airways making it harder to breathe. Whereas, in emphysema the air sacs get damaged so while air can fill the lungs its hard to expel.

How does Spiriva help?

Spiriva (tiotropium bromide) is inhaled once a day and works by opening up the narrowed and diseased airways for easier breathing. Spiriva must be continued even when breathing seems better because missing a dose may worsen the condition.

What does this news from the FDA mean for patients taking Spiriva?

Right now the FDA has released just preliminary information to inform health care providers and their patients about the possible association between Spiriva and stroke. The concern came about through the pooled analysis from 29 placebo clinical trials comparing the effects between patients who were taking Spiriva and those who were given a placebo.

There were 13,500 patients with COPD in the 29 trial studies taking Spiriva for one year. In the Spiriva group 8 out every 1000 developed stroke. Whereas, in the placebo group 6 out of every 1000 developed stroke. The excess of stroke risk is 2 in every 1000 when comparing the two groups.

How does this news affect Spiriva users?

Don't stop taking your medication. Spiriva is indicated for the long-term treatment of COPD and abruptly stopping this medication may worsen the condition. The FDA has released early communication to inform physicians and the public of the latest information associated with Spiriva. These early findings have not been confirmed by the FDA. The FDA has requested more data from Boerhinger and is working to get more information on this potential risk in patients taking Spiriva.
What can you do to help?

If you're taking Spiriva be sure to report your side effects to your doctor. This contributes to data used in safety reports regarding the effects of drugs. This contributes to post-marketing information about drugs which is used by the FDA to report any adverse effects of Spiriva to the public. In the meantime, keep a look out this summer for the results of Boehringer's four year study UPLIFT which is looking at the long-term effects of Spiriva's safety.

Sources: http://www.webmd.com/a-to-z-guides/chronic-obstructive-pulmonary-disease-copd-overview, http://www.fda.gov/cder/drug/early_comm/tiotropium.htm