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FDA says yes to Nothera for NOH treatment

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to treat neurogenic orthostatic hypotension

Northera capsules (droxidopa) have been approved by the FDA for the treatment of neurogenic orthostatic hypotension (NOH), a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure.

Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.

“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” stated Dr.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.”

The most common adverse events reported by clinical trial participants taking Northera were headache, dizziness, nausea, high blood pressure (hypertension) and fatigue. In addition boxed warnings also list risks including increased blood pressure while lying down (supine hypertension), which can cause stroke particularly in patients with Shy-Drager syndrome and Parkinson disease

According to medical experts, “It is essential that these 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.

Source: FDA
To learn more readers can call 888-INFO-FDA

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