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FDA Approves Adempas to Treat Pulmonary Hypertension

Adempas is among a class of drugs called soluble guanylate cyclase stimulators
WEDNESDAY, Oct. 9 (HealthDay News) -- Adempas (riociguat) has been approved by the U.S. Food and Drug Administration to treat chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) of various causes.
Adempas is among a class of drugs called soluble guanylate cyclase stimulators, which relax the arteries to increase blood flow and decrease blood pressure, the agency said. The drug was approved for people with CTEPH after surgery, or for people who cannot have surgery, to help improve the ability to exercise. The drug also was approved for people with PAH of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition.
Adempas was evaluated in a clinical study involving 261 people with CTEPH. People who were treated with the drug were able to walk about 150 feet further in six minutes after 16 weeks of treatment than people who took a placebo, the FDA said. In another trial of 443 people with PAH, those treated with the drug were able to walk about 118 feet further in six minutes than those who had been treated with a placebo.
The most common side effects of the drug included headache, dizziness, dyspepsia, peripheral edema, nausea, and vomiting. The label for Adempas includes a boxed warning that pregnant women shouldn't use the drug, which can harm a growing fetus, the agency said.
The drug is marketed by Wayne, N.J.-based Bayer HealthCare Pharmaceuticals.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370866.htm )
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