Comment on “Low dose oral minoxidil for treating alopecia: A 3-year North American retrospective case series”: Adding further evidence about side effects

Abstract

To the Editor: We read with interest the article by Beach et al1Beach R.A. McDonald K.A. Barrett B.M. Low dose oral minoxidil for treating alopecia: a 3-year North American retrospective case series.J Am Acad Dermatol. 2021; 84: 761-763Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar addressing the tolerability and effectiveness of low-dose oral minoxidil (LDOM) for treating androgenetic alopecia. With regard to tolerability, a recent review found that, except for hypertrichosis, side effects were infrequent.2Randolph M. Tosti A. Oral minoxidil treatment for hair loss: a review of efficacy and safety.J Am Acad Dermatol. 2021; 84: 737-746Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar,3Jimenez-Cauhe J. Saceda-Corralo D. Rodrigues-Barata R. et al.Characterization and management of hypertrichosis induced by low-dose oral minoxidil in the treatment of hair loss.J Am Acad Dermatol. 2021; 84: 222-223Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Those results are consistent with the ones of the referred study. To provide further evidence of the safety of LDOM for androgenetic alopecia, we explored the US Food and Drug Administration Adverse Event Reporting System (FAERS) Database4Food and Drug AdministrationFood and Drug Administration Adverse Event Reporting System [database].https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/33a0f68e-845c-48e2-bc81-8141c6aaf772/state/analysisGoogle Scholar from inception (1969) to Nov 11, 2020 and summarized minoxidil-related information. This database contains information of adverse events reported by drug manufacturers, health care professionals, or consumers. The aim of this study was merely descriptive. A total of 57,129 minoxidil-associated adverse events were reported to FAERS, including 12,303 considered serious events and 203 deaths. After filtering by indication for alopecia, total adverse events, serious adverse events and deaths reduced to 19,755, 1870 and 27, respectively. Of these, 13,784 (69.77%) occurred in women and 5497 in men (27.83%), leaving the sex unspecified for 474 cases. Interestingly, 17,957 (90.9%) reports were received after 2014. Most of the adverse events were related to the use of topical minoxidil. Thus, to focus on reports of patients under LDOM, we further restricted the search adding the term Loniten (minoxidil tablet; Pfizer). We found a total of 8 Loniten-related adverse events in the use for alopecia. All of them were classified as serious. The female/male proportion was reversed to 1:3. Half of the patients were older than 70 years, and only 3 required hospitalization. None of the patients died. The most frequent adverse events were peripheral edema (4 of 8 patients; 50%) and angina pectoris/chest pain (2 of 8 patients; 25%). Other adverse events included flushing, asthenia, dizziness, epistaxis, hepatic cancer, colon cancer, or lymphoma (Table I).Table IEpidemiologic and clinical features of the cohort of 8 patients treated with oral minoxidil for alopecia (Loniten) that presented serious adverse eventsPatient no.Product nameDoseReason for useReactionsSeriousnessOutcomesSexEvent date (y)Age (y)Weight (kg)SenderReporter type1LonitenNSAlopeciaFlushing; edema peripheralSeriousOther outcomesF20027561PfizerConsumer2LonitenNSAlopeciaEpistaxis; hepatic cancerSeriousHospitalizedM200046NSPfizerHealthcare professional3LonitenNSAlopeciaAngina Pectoris; Chest PainSeriousOther outcomesM20007060PfizerHealthcare professional4LonitenNSAlopeciaLymphoma; edemaSeriousOther outcomesMNSNSNSPfizerConsumer5LonitenNSAlopeciaEdema peripheral; asthenia; flushing; face edemaSeriousOther outcomesF20027561PharmaciaNS6LonitenNSAlopeciaAngina pectoris; chest painSeriousOther outcomesM20007060PharmaciaHealthcare professional7LonitenNSAlopeciaHepatic cancer; dizziness; colon cancer; epistaxisSeriousHospitalizedM200046NSPharmaciaHealthcare professional8LonitenNSAlopeciaEdema peripheral; lymphomaSeriousHospitalizedMNSNSNSPharmaciaConsumerData extracted from FAERS database. NS, Not specified. Open table in a new tab Data extracted from FAERS database. NS, Not specified. Our FAERS search yielded a low absolute number of reported adverse events with the use of LDOM for alopecia. These results are consistent with our experience and that of Beach et al.1Beach R.A. McDonald K.A. Barrett B.M. Low dose oral minoxidil for treating alopecia: a 3-year North American retrospective case series.J Am Acad Dermatol. 2021; 84: 761-763Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar, 2Randolph M. Tosti A. Oral minoxidil treatment for hair loss: a review of efficacy and safety.J Am Acad Dermatol. 2021; 84: 737-746Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar, 3Jimenez-Cauhe J. Saceda-Corralo D. Rodrigues-Barata R. et al.Characterization and management of hypertrichosis induced by low-dose oral minoxidil in the treatment of hair loss.J Am Acad Dermatol. 2021; 84: 222-223Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar Even though the 8 (100%) reported adverse events were considered serious, they occurred over 50 years, none of the patients died, and only 3 (37.5%) required hospitalization. Furthermore, it is doubtful that some of the adverse events can be considered drug related, such as hepatic cancer or lymphoma. Others, such as peripheral edema or angina pectoris, have been studied extensively, and their causal relationship is established.2Randolph M. Tosti A. Oral minoxidil treatment for hair loss: a review of efficacy and safety.J Am Acad Dermatol. 2021; 84: 737-746Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar,3Jimenez-Cauhe J. Saceda-Corralo D. Rodrigues-Barata R. et al.Characterization and management of hypertrichosis induced by low-dose oral minoxidil in the treatment of hair loss.J Am Acad Dermatol. 2021; 84: 222-223Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar However, they seem more frequent with high doses for other indications than with the doses used in alopecia.2Randolph M. Tosti A. Oral minoxidil treatment for hair loss: a review of efficacy and safety.J Am Acad Dermatol. 2021; 84: 737-746Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar,5Jimenez-Cauhe J. Saceda-Corralo D. Rodrigues-Barata R. et al.Effectiveness and safety of low-dose oral minoxidil in male androgenetic alopecia.J Am Acad Dermatol. 2019; 81: 648-649Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar The FAERS system has important limitations, including potential unverified information, potential underreporting, and lack of information about frequency of use. Thus, prevalence or incidence cannot be calculated and causal relationships between drugs and adverse events cannot be confirmed.4Food and Drug AdministrationFood and Drug Administration Adverse Event Reporting System [database].https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/33a0f68e-845c-48e2-bc81-8141c6aaf772/state/analysisGoogle Scholar Additionally, the restrained search using the brand name Loniten could potentially exclude some reports. LODM-associated adverse events appear to be rare. However, further studies in larger cohorts are needed to confirm the safety profile of this promising emergent therapy for alopecia patients. None disclosed. Low-dose oral minoxidil for treating alopecia: A 3-year North American retrospective case seriesJournal of the American Academy of DermatologyVol. 84Issue 3PreviewTo the Editor: Alopecia remains a therapeutic challenge to dermatologists. Topical 5% minoxidil is a Food and Drug Administration (FDA)–approved treatment for androgenetic alopecia (AGA), with a variable response rate. Studies suggest that low dose oral minoxidil (LDOM) requires decreased follicular enzymatic activity compared with its topical form.1 Although reports document its successful use in dermatology, adaptation in North America has been low. It is unclear whether this is due to concern about patient safety or lack of established oral minoxidil dosing for hair loss. Full-Text PDF Open AccessSide effects of low-dose oral minoxidil for treating alopeciaJournal of the American Academy of DermatologyVol. 84Issue 5PreviewTo the Editor: We appreciate the analysis of minoxidil-related information of adverse events by Ortega-Quijano and colleagues, particularly the information highlighting 8 patients prescribed oral minoxidil (Loniten; Pfizer). Full-Text PDF