At long last: New consensus statement for off-label hair loss treatment

There is now a consensus statement addressing the off-label use of low dose oral minoxidil (LDOM) used to treat hair loss.Developed by 43 hair loss specialist dermatologists from 12 countries, it was published in JAMA Dermatology. Given that this use is off-label, it was time for guidelines, said Dr. Cathryn Sibbald, a dermatologist and coauthor of the statement, as well as an assistant professor of medicine at the University of Toronto.Currently, “there is significant variation in how clinicians prescribe it. This consensus helps to provide guidance for clinicians who may not have experience using it, including typical doses, possible indications, side effects and monitoring,” she told the Canandian Healthcare Network. The oral form of the drug was approved by the U.S. FDA for use in treating hypertension, but not as a first-line agent due to adverse effects. As it was, a significant adverse effect of oral minoxidil was hypertrichosis, which lead to the development of a spin-off use—topical minoxidil as a hair growth agent in the 1980s. But the oral version was not approved for the hair loss indication.In the interim, “a growing number of research groups have reported on the off-label use of low-dose oral minoxidil (LDOM), ranging from 0.25mg to 5mg daily, as a safe and effective treatment option for male and female patients with AGA (androgenetic alopecia),” the statement said. One consequence is that in recent years the use of LDOM has become more common highlighting a need for a consensus statement.The process for creating the statement included a review of the medical literature on the pharmacological properties, adverse effect profile, and use of LDOM for patients with hair loss. Studies that were included had to met a 70% consensus from participating experts who had clinical expertise and experience with LDOM.Dr. Sibbald noted that LDOM has a potential role in a variety of different hair loss disorders.“Many patients with hair loss can benefit from LDOM, either on its own or with other medications. It is an attractive option to many given that it is generally not expensive and does not suppress the immune system. Hopefully this publication will allow clinicians to feel more comfortable prescribing it, and ultimately improve our treatment of patients with hair loss,” she said.Highlights of the consensus:Patient populations. LDOM treatment may be considered for adult and adolescent patients. However, its use in the pediatric population did not reach censensus.Indications. There was strong consensus that LDOM may provide direct benefit for AGA and age-related patterned thinning as well as for conditions with follicular miniaturization or hair cycle disruption. There was also a high rate of consensus for LDOM use in several forms of cicatricial alopecia: lichen planopilaris; frontal fibrosing alopecia; central centrifugal alopecia agreed, and fibrosing alopecia in a patterned distribution.Oral versus topical treatment. LDOM may be favoured over the topical form when LDOM costs less; is more convenient; topical minoxidil causes styling issues, undesirable product residue, or hair texture changes if there is scalp inflammation from topical minoxidil; when topical minoxidil is ineffective, or there is a desire for enhanced hypertrichosis are relevant to the patient such as in the transgender patient population.Contraindications and precautions. According to the statement, the following should be considered as contraindications for LDOM use: ongoing alternate drug therapy interacting significantly with oral minoxidil; history of pericardial effusion/ tamponade; history of pericarditis; congestive heart failure; history of pulmonary hypertension associated with mitral stenosis; pheochromocytoma; and pregnancy or breastfeeding. Precautions highlighted included a patient history of tachycardia or other arrhythmia; hypotension indicated by blood pressure level less than 90/60mmHg; kidney function impairment; and patients who undergo dialysis.Consultation. The statement recommended that specialty consultation with primary care or cardiology clinicians may be sought before prescribing LDOM.Baseline testing before prescribing LDOM. If patients lack medical conditions that warrant precautions, baseline laboratory and electrocardiogram evaluation results are not routinely indicated. But in the presence of relevant precautions, baseline laboratory and electrocardiogram evaluation may be considered in consultation with a specialist, the statement said.Dosing. The statement highlights several factors that should be taken into consideration when deciding on doses. These include sex, age, the amount of hypertrichosis desired, the risk for systemic adverse effects as well as the severity of baseline hair loss. Dosing practices of the experts in the consensus group are included. Additional agents. There was strong consensus that spironolactone could be a useful adjunctive agent in patients who are biologically female or transgender female patients who have hirsutism; acne; or with polycystic ovary syndrome or other excess androgen syndromes. Monitoring. Blood pressure monitoring is recommended for patients identified as having a precaution. Monitorig for adverse effects should also be conducted in patients with risk factors, at the start of LDOM treatment, and those getting an increased dose.Adverse effects. One concerns is that “vasodilation secondary to oral minoxidil occurs acutely and depends on dose with peak effect occurring within three to seven days. Patients can be counseled to monitor for sequelae including lightheadedness, dizziness, and fast or abnormal heartbeat.” If there is water retention, patients should avoid consuming too much salt.The authors noted that a limitation of the consensus is that the opinions expressed may not necessarily reflect what other experts might say. Also, because there was a lack of consensus on pediatric use and dosing “underscores the need for further research in the pediatric population,” the statement said.

At long last: New consensus statement for off-label hair loss treatment

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