Thursday, February 23, 2012

Lung Drug May Be Tied to Cardiovascular Deaths, FDA Says

From Bloomberg:

An experimental drug to treat breathing complications tied to a common lung disease may be linked to more instances of cardiovascular deaths at higher doses, U.S. regulators said.
The twice-daily drug known chemically as aclidinium bromide helped patients with chronic obstructive pulmonary disease, or COPD, breathe easier, Food and Drug Administration staff said today in a report. Advisers to the agency are set to meet Feb. 23 to weigh whether safety questions about the medicine have been adequately assessed.

COPD, tied to smoking as a cause, is an umbrella term for conditions that make it difficult to breath, according to the National Institutes of Health. If approved, the drug may have $150 million in sales for New York-based Forest in 2015, according to the average of two analysts’ estimates compiled by Bloomberg.
“It is striking that all the cardiovascular deaths are reported for the higher aclidinium dose,” the FDA said in its report on the drug. “It is difficult to dismiss the apparent imbalance in cardiovascular death between the treatment groups, while at the same time, impossible to conclude that the data represent a true safety signal,” the agency said.