FDA Approves Low Blood Pressure Drug
The United States Food and Drug Administration (FDA) has approved a new drug to treat low blood pressure caused by neurological disorders. This condition, medically known as neurogenic orthostatic hypotension (NOH), is a rare but chronic condition with symptoms that include dizziness, lightheadedness, blurred vision, fainting while standing and fatigue. Chelsea Therapeutics International Ltd's drug, Northera, could help alleviate these symptoms.
"People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing," said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research. "There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available."
Back in January, the advisory panel to the FDA recommended approval of the drug. However, the panel of experts had also recommended that Chelsea Therapeutics conduct one more follow-up study to examine the long-term benefits of the drug. According to the panelists, there were some gaps in the clinical data that made it unclear whether or not Northera could treat low blood pressure over an extended period of time.
Although the agency listened to the recommendation and requested for a follow-up study, it decided to approve Northera on an "accelerated" basis. This type of approval allows the drug, which is currently in more trials, to be used for serious cases. One of the most serious side effects of taking the drug is an increased risk of supine hypertension, which is increased blood pressure that occurs when the body is lying down. This side effect increases risk of stroke as well.
"It is essential that patients be reminded that they must sleep with their head and upper body elevated. Supine blood pressure should be monitored prior to and during treatment and more frequently when increasing doses," the FDA wrote in its news release.
The drug's packaging will list all of the side effects of taking the drug.