Northera Approved For Rare Blood Pressure Condition
WEDNESDAY Feb. 19, 2014, 2014 -- Northera (droxidopa) has been approved by the U.S. Food and Drug Administration to treat a rare, chronic condition characterized by a sudden drop in blood pressure when a person stands.
Neurogenic orthostatic hypotension (NOH) is most often associated with Parkinson's disease and other neurologic disorders. Symptoms may include dizziness, lightheadedness, blurred vision, fatigue and fainting, the FDA said in a news release.
Granted accelerated approval to treat a rare condition, the drug will have a boxed label warning that it could cause an unhealthy rise in blood pressure while a person is lying down. This potential side effect could lead to a stroke, the agency said, warning that Northera users should be monitored carefully.
Other less serious side effects could include headache, dizziness, nausea, high blood pressure and fatigue, the FDA said.
Northera is produced by Chelsea Therapeutics, based in Charlotte, N.C.
The FDA has more about this approval.
Posted: February 2014