Droxidopa Availability in Canada
Droxidopa is NOT currently approved or available in Canada for the treatment of neurogenic orthostatic hypotension. While droxidopa received FDA approval in the United States in February 2014 for symptomatic neurogenic orthostatic hypotension 1, and the American Diabetes Association guidelines note that "Midodrine and droxidopa are approved by the FDA for the treatment of orthostatic hypotension" 2, there is no corresponding approval from Health Canada.
Key Clinical Context
The evidence specifically mentions that tapentadol (an opioid for neuropathic pain) "has regulatory approval in the U.S. and Canada" 2, but no such statement exists for droxidopa, indicating it lacks Canadian regulatory approval.
Alternative Treatment Options Available in Canada
For Canadian patients with neurogenic orthostatic hypotension, the following evidence-based treatments are recommended 2:
First-Line Non-Pharmacologic Interventions
- Acute water ingestion (≥240-480 mL) for temporary relief, with peak effect at 30 minutes 2
- Physical counter-pressure maneuvers including leg crossing, squatting, and lower body muscle tensing 2
- Compression garments that are at least thigh-high and preferably include the abdomen 2
Pharmacologic Alternatives
- Midodrine: Improves symptoms with dose-dependent blood pressure increases; limited by supine hypertension, scalp tingling, piloerection, and urinary retention 2
- Fludrocortisone: Increases plasma volume; avoid as first-line if supine hypertension present; side effects include edema, hypokalemia, and potential adrenal suppression at doses >0.3 mg daily 2
- Increased salt and fluid intake: 6-9 g (100-150 mmol) of salt daily may be reasonable unless contraindicated by hypertension, renal disease, or heart failure 2
Refractory Cases
- Pyridostigmine: For patients refractory to other treatments; side effects include nausea, vomiting, abdominal cramping, and urinary incontinence 2
- Octreotide: For refractory recurrent postprandial or neurogenic orthostatic hypotension 2
Important Caveats
Canadian clinicians should be aware that while droxidopa demonstrates efficacy in improving orthostatic hypotension symptoms and standing blood pressure in multiple randomized controlled trials 3, 4, 5, 6, its unavailability in Canada necessitates reliance on the alternative agents listed above, which are supported by the same ACC/AHA/HRS guidelines 2.