Opsumit Approved for Pulmonary Arterial Hypertension

Opsumit Approved for Pulmonary Arterial Hypertension

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, a debilitating disease characterized by high blood pressure in the lung arteries.

Pulmonary hypertension causes the heart to overwork, which can limit exercise, cause shortness of breath and create the need for a lung transplant. Opsumit relaxes the lung 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, cold-like symptoms, 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 US, based in San Francisco.

More information

To learn more about PAH, visit the U.S. National Heart, Lung and Blood Institute.

 
Today's Interactive Tools
Related Items

The third-party content provided in the Health Library of phoebeputney.com is for informational purposes only and is not designed to diagnose or treat a health problem or disease, or replace the professional medical advice you receive from your physician. If you or your child has or suspect you may have a health problem, please consult your primary care physician. If you or your child may have a medical emergency, call your doctor or 911 or other emergency health care provider immediately in the United States or the appropriate health agency of your country. For more information regarding site usage, please visit: Privacy Information, Terms of Use or Disclaimer.