The FDA has announced its approval of the drug Opsumit (macitentan), a to treat adults with pulmonary arterial hypertension, and delay its progression by helping act to relax the pulmonary arteries, thus decreasing blood pressure in the lungs.
Generally refered to a PAH. pulmonary arterial hypertension (aka high blood pressure in the lungs), is a chronic, progressively debilitating disease that cause the right side of the heart to exert itself more than usual in order to pump blood through the lungs. As a result of the decreased blood flow, less oxygen is gets to the rest of the body. While initial symptons are generally dizziness, shortness of breath, and fatigue, some patients may also have swelling in their legs and ankles. If left untreated, PAH eventually can lead to the need for a lung transplant, or even death.
As with other endothelin receptor blocker drugs, typical side effects of Opsumit include anemia as well as “common cold-like symptoms” such as sore throat, bronchitis, headache, flu and urinary tract infection. While these may seem relatively mild, the FDA warns that pregnant women should not use it because it can harm the developing fetus. In fact, all female patients must be enrolled in the Opsumit Risk Evaluation and Mitigation Strategy (REMS) Program, which requires them to “comply with applicable pregnancy testing and contraception requirements before treatment can be initiated.” In addition the drug can only be dispensed by certified prescribers also enrolled in the program.
To learn more about Opsumit, medical practioners as well as patients can contact the FDA at 888-INFO-FDA