FDA Updates Early Communication about Spiriva HandiHaler Side Effects

Yesterday the FDA issued an update to an early communication originally released in March 2008 regarding Spiriva Handihaler side effects. After reviewing preliminary data from a four year study, the drug regulators indicated that the results do not indicate an increased risk of strokes associated with the COPD inhaler.

The FDA statement did not address recent concerns which emerged last month after publication of two independent reports that indicated there may be an increased risk of heart attacks and death from Spiriva.

Spiriva HandiHaler is a once-daily inhaled medication used for long-term maintenance treatment of bronchospasm linked to chronic pulmonary obstructive disease (COPD). Since it was approved by the FDA in 2004, it has grown to dominate the market for COPD inhalers and has been used by millions of Americans.

The original Spiriva early communication was issued by the FDA on March 18, 2008, after a combined analysis of 29 clinical trials suggested that Spiriva side effects may pose a slight increase in the risk of stroke when compared to the use of a placebo.

Yesterday’s update was released after the FDA reviewed preliminary data from a large four year study known as UPLIFT, which compared the use of Spiriva HandiHaler to placebo among roughly 6,000 individuals who suffered from COPD.

After evaluating the preliminary findings of the study released by the drug maker, the FDA updated the March early communication to indicate that the data shows that there is no increased stroke risk with Spiriva HandiHaler compared to a placebo.

The updated statement does not reach any conclusions about the cardiovascular concerns which emerged last month after two separate reports were published by independent researchers about Spiriva side effects which could increase the risk of heart attacks, strokes and death. One of those studies involved an analysis of combined data from 17 clinical trials with nearly 15,000 people with COPD, and the other was a case-control study that involved over 32,000 people who were treated for chronic obstructive lung disease.

The FDA indicates that they will not receive complete data on the UPLIFT study until November 2008. That will likely help them evaluate the issues surrounding mortality and cardiovascular effects of Spiriva. However, the agency expects that it will take several months to complete their review of the data once it is received.