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Northera

"The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associate"...

Northera

SIDE EFFECTS

The following adverse reactions with NORTHERA are included in more detail in the WARNINGS AND PRECAUTIONS section of the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety evaluation of NORTHERA is based on two placebo-controlled studies 1-2 weeks in duration (studies 301 and 302), one 8-week placebo-controlled study (study 306) and two long-term open label extension studies (studies 303 and 304). In the placebo-controlled studies, a total of 485 patients with Parkinson's disease, multiple system atrophy, pure autonomic failure, dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy were randomized and treated, 245 with NORTHERA and 240 with placebo [see Clinical Trials].

Placebo-Controlled Experience

The most commonly observed adverse reactions (those occurring at an incidence of greater than 5% in the NORTHERA group and with at least a 3% greater incidence in the NORTHERA group than in the placebo group ) in NORTHERA-treated patients during the three placebo-controlled trials were headache, dizziness, nausea, hypertension. The most common adverse reactions leading to discontinuation from NORTHERA were hypertension or increased blood pressure and nausea.

Table 1: Most Common Adverse Reactions Occurring More Frequently in the NORTHERA Group

  Study 301 and Study 302
(1-2 Weeks Randomized Treatment)
Study 306
(8-10 Week Randomized Treatment)
Placebo
(N=132)
n (%)
NORTHERA
(N=131)
n (%)
Placebo
(N=108)
n (%)
NORTHERA
(N=114)
n (%)
Headache 4 (3.0) 8 (6.1) 8 (7.4) 15 (13.2)
Dizziness 2 (1.5) 5 (3.8) 5 (4.6) 11 (9.6)
Nausea 2 (1.5) 2 (1.5) 5 (4.6) 10 (8.8)
Hypertension 0 2 (1.5) 1 (0.9) 8 (7.0)
Note: n=number of patients. Table displays adverse reactions that were reported in greater than 5% of patients in the NORTHERA group and with at least a 3% greater incidence in the NORTHERA group than in the placebo group.

Long-Term, Open-Label Tr ials with NORTHERA

In the long-term open label extension studies, a total of 422 patients, mean age 65 years, were treated with NORTHERA for a mean total exposure of approximately one year. The commonly reported adverse events were falls (24%), urinary tract infections (15%), headache (13%), syncope (13%), and dizziness (10%).

Read the Northera (droxidopa capsules) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drugs That Increase Blood Pressure

Administering NORTHERA in combination with other agents that increase blood pressure (e.g., norepinephrine, ephedrine, midodrine, and triptans) would be expected to increase the risk for supine hypertension.

Parkinson's Medications

Dopa-decarboxylase inhibitors may require dose adjustments for NORTHERA.

Last reviewed on RxList: 2/27/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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