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Roflumilast Approved for Form of COPD

Roflumilast Approved for Form of COPD

03/01/11

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 bronchitis.

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 Forest Laboratories.

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.

More information

The U.S. National Heart Lung and Blood Institute has more about COPD.

Copyright © 2011 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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