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FDA Approves Opsumit for Pulmonary Arterial Hypertension

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FDA Approves Opsumit for Pulmonary Arterial Hypertension

Opsumit (macitentan) relaxes the pulmonary arteries, decreasing blood pressure in the vessels

WEDNESDAY, Oct. 23 (HealthDay News) -- Opsumit (macitentan) has been approved by the U.S. Food and Drug Administration to treat adults with pulmonary arterial hypertension.

Opsumit relaxes the pulmonary arteries, decreasing blood pressure in the vessels, the FDA said in a news release.

The drug's safety and effectiveness were evaluated in clinical studies involving 742 people. The medication was found effective in "delaying disease progression," the agency said.

The most common side effects included anemia, nasopharyngitis, bronchitis, headache, flu, and urinary tract infection.

Opsumit's label includes a boxed warning that the medication could harm a developing fetus, so the drug should not be taken by pregnant women, the FDA said.

The drug is marketed by Actelion Pharmaceuticals U.S., based in San Francisco.

More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm371362.htm )