TUESDAY, March 1 (HealthDay News) -- Roflumilast has been
approved by the U.S. Food and Drug Administration to treat flares
of chronic obstructive pulmonary disease (COPD) involving chronic
The lung disease leads to labored breathing, and is
characterized by chronic cough and excessive phlegm. A flare may
last for weeks and puts patients at increased risk of death, the
FDA said. Cigarette smoking is the leading cause of COPD.
Roflumilast is marketed as Daliresp by New York City-based
Roflumilast blocks an enzyme called phosphodiesterase type 4.
The drug is not intended to treat another form of COPD, primary
emphysema, the FDA said.
The medication's safety and effectiveness were evaluated in
clinical studies involving more than 1,500 people, 40 and older,
who had a worsening of chronic bronchitis during the prior year.
Roflumilast was approved with a guide that informs users of
potential serious side effects, including changes in mood, thinking
or behavior, and unexpected weight loss, the agency said.
The most common adverse reactions were diarrhea, nausea,
headache, insomnia, back pain, loss of appetite and dizziness.
Roflumilast shouldn't be used to treat sudden breathing problems,
and isn't recommended for people younger than 18.
The U.S. National Heart Lung and Blood Institute has more about