Money Matters, Simplified.
Spiriva declared safe by FDA
by Neka Sehgal - January 15, 2010 - comments
The FDA announced Thursday that there is no evidence of Spiriva HandiHaler increasing heart risks for controlling COPD in patients treated with it.
Washington, January 15 -- Following a safety review the U.S. Food and Drug Administration (FDA) negated the allegations that Spiriva HandiHaler increased stroke risks in patients using it to control chronic obstructive pulmonary disease (COPD).
Spiriva HandiHaler manufactured by German drug maker Boehringer Ingelheim and co-marketed in the U.S. with Pfizer is the commonly prescribed treatment for COPD. The device consists of drug capsules with an inhaler to combat coughing, wheezing and shortness of breath.
Safety review of Spiriva conducted
In 2008, the health regulators had initiated a safety review of tiotropium [Spiriva], the medicine's active ingredient, after clinical studies indicated that the drug may be linked with an increased risk of stroke.
The agency was also investigating whether the product also elevated the rates of heart attacks and deaths from cardiovascular causes.
"FDA has now completed its review and believes the available data do not support an association between the use of Spiriva HandiHaler and an increase risk for these serious adverse events," the agency said in a statement posted to its Web site Thursday.
According to an agency statement the "FDA is advising healthcare professionals to continue to prescribe Spiriva HandiHaler as recommended in the drug label.”
The announcement by the regulators clearing the drug of any adverse cardiovascular effects comes as a relief to many COPD patients who rely on the Spiriva HandiHaler to control their condition.
Analysis of data of 5,992 COPD patients
The FDA cleared the tiotropium inhaler of suspicion after the study Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT), which compared tiotropium bromide inhalation powder with a placebo in 5,992 patients with COPD, released its findings.
Further in November 2009, the FDA Pulmonary - Allergy Drugs Advisory Committee also reviewed the data from the UPLIFT study and resolved the potential safety concerns for the inhaler.
A little about COPD
COPD is a progressive respiratory disease that causes significant deterioration of lung function and chronic breathlessness that can lead to severe disability.
Limited airflow associated with the ailment leads to excess air being trapped in the lungs after a person has exhaled.
This condition, known as "air trapping", is a primary cause of breathlessness, which often restricts a person's ability to perform daily activities such as walking up stairs or taking a shower.
According to the National Institutes of Health, COPD caused by damaged lungs, is the fourth leading cause of death in the U.S., and is primarily due to smoking.