Orthostatic Hypotension Drug Updated with New Warnings

Labeling updated with new warnings
Labeling updated with new warnings

The Food and Drug Administration (FDA) has approved updated labeling for Northera (droxidopa capsules; Lundbeck) to include new information regarding hypersensitivity reactions and potential drug interactions.

Northera, a norepinephrine prodrug, is indicated to treat symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. The approved sNDA contains revisions to the Contraindications, Warnings and Precautions, Drug Interactions, and Specific Populations sections. 

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A new Contraindication has been added to state the following: "Northera is contraindicated in patients who have a history of hypersensitivity to the drug or its ingredients."

Under Warnings and Precautions, the following text was added: "Hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, urticaria and rash have been reported in postmarketing experience. Some of these reactions resulted in emergency treatment. If a hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy."

Under Drug Interactions, a new section on non-selective MAO inhibitors was added: "The concomitant use of selective MAO-B inhibitors, such as rasagiline or selegiline, was permitted in the Northera clinical trials. However, based on mechanism of action, the use of non-selective MAO inhibitors and linezolid should be avoided as there is a potential for increased blood pressure when taken with Northera."

Northera is available as 100mg, 200mg, and 300mg strength capsules in 90-count bottles.

For more information call (866) 337-6996 or visit Northera.com.