Experts Release Recs on Off-Label Use of Oral Minoxidil for Hair Loss

An international expert consensus statement provided best-practice recommendations for the off-label use of low-dose oral minoxidil among patients with hair loss.

Using a modified Delphi process, 43 hair-loss specialist dermatologists from 12 countries reached consensus on 76 items, including diagnoses for which oral minoxidil may provide benefit, indications for oral versus topical minoxidil, dosing for adults and adolescents, contraindications, precautions, baseline evaluation, monitoring, adjunctive therapy, and specialty consultation, reported Jennifer M. Fu, MD, of the University of California San Francisco, and colleagues.

Meanwhile, pediatric use and dosing items for children younger than 12 years, as well as titration protocols, fell short of consensus, they noted in JAMA Dermatology.

“Topical minoxidil is FDA-approved for the treatment of hair loss, yet patient compliance can be poor,” Fu told MedPage Today. “Patients often tell us that topical minoxidil is difficult to apply, leaves an undesirable residue, and can be drying and irritating.”

“At antihypertensive dosing (10 to 40 mg daily), oral minoxidil has been associated with adverse effects, especially in patients with cardiovascular and renal comorbidities, and yet increasingly, research groups are reporting on the safe and effective use of low-dose oral minoxidil (0.25 to 5 mg daily) for the treatment of hair loss,” she said.

The authors noted that the current data on oral minoxidil initiation and monitoring for hair loss are limited, and “there is a pressing need for an expert consensus-based statement for common use to maximize hair growth and minimize cardiovascular and other adverse effects.”

In their review, the experts reached strong consensus for low-dose oral minoxidil providing direct benefit for androgenetic alopecia and age-related patterned thinning (97.7% of experts for both), alopecia areata (81.4%), telogen effluvium (86%), traction alopecia (79.1%), and persistent chemotherapy-induced alopecia and endocrine therapy-induced alopecia (83.7% for both).

The group also agreed that oral minoxidil may be favored over topical minoxidil when the oral version is less expensive (70.5%) and is more convenient (93.2%), and when topical treatment has undesirable cosmetic effects (95.5%), coincides with primary or secondary scalp inflammation (93.2%), or produces an inadequate response (90.9%), and when the patient is seeking enhanced hypertrichosis (e.g., the transgender patient population; 86.4%).

Patient characteristics that may inform the determination of starting dosing of oral minoxidil included sex (76.7%), age (for adults 81.4%; for adolescents 83.7%), a patient’s attitude regarding hypertrichosis (93%), and the risk for systemic adverse effects (97.7%). Nearly 75% of experts considered extent of baseline hair loss important in determining the maximum dosages of oral minoxidil.

Contraindications for use included significant interaction with ongoing alternate drug therapy (86.4%), history of pericardial effusion/tamponade (81.8%), history of pericarditis (72.7%), congestive heart failure (79.1%), history of pulmonary hypertension associated with mitral stenosis (76.7%), pheochromocytoma (74.4%), and pregnancy or breastfeeding (95.5%).

“When indicated, colleagues from primary care or cardiology may be useful consultants to review potential contraindications and precautions, or when coordination of care is needed; for example, when low-dose oral minoxidil may be incorporated into a patient’s existing antihypertensive regimen,” Fu said.

“Our expert panel reached consensus that in the absence of precautions, baseline laboratory and baseline electrocardiogram testing are not routinely indicated prior to oral minoxidil initiation,” she noted, adding that patients should be advised of and monitored for “the sequelae of vasodilation (lightheadedness or dizziness and fast or abnormal heartbeat), the sequelae of salt and fluid retention (swollen feet or legs, facial swelling, weight gain, chest pain, shortness of breath), and additionally, hypertrichosis, headache, and signs of an allergic reaction.”

Over 90% of experts agreed on the addition of spironolactone in biological female or transgender female patients with hirsutism, acne, or polycystic ovary syndrome (or another excess androgen syndrome).

“Spironolactone coadministration may [also] be considered in biological female or transgender female patients when lower extremity edema or facial edema is present” (81.4% and 72.1% of experts agreed, respectively), and, when appropriate, beta-blockers may be coadministered in consultation with a specialist, Fu and colleagues noted.

“Considering the evolving landscape surrounding low-dose oral minoxidil use, it is imperative to acknowledge that individualized patient needs and responses may vary, and clinicians should exercise their judgment in tailoring low-dose oral minoxidil prescriptions and dosing accordingly,” the group concluded.

For this consensus statement, Fu and colleagues reviewed the current literature on the pharmacological properties, adverse effect profile, and use of low-dose oral minoxidil for patients with hair loss. Consensus was reached if at least 70% agreed or strongly agreed on a 5-point Likert scale. Over four survey rounds, 180 items in the first round, 121 items in the second round, 16 items in the third round, and 11 items in the fourth round were considered and revised.

Experts who participated in all four survey rounds had a median of 15 years of post-residency dermatology experience and a median of 5 years of experience prescribing low-dose oral minoxidil for patients with hair loss. About 98% reported treating adults with hair loss, 55.8% reported treating adolescents (ages 12-17), and 39.5% reported treating pediatric patients (ages