title: Chemical Leukoderma Associated with Methylphenidate Transdermal System: Data From the US Food and Drug Administration Adverse Event Reporting System.
abstract: To identify and characterize cases of chemical leukoderma, an underrecognized adverse event, associated with the methylphenidate transdermal system (MTS) reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS).
  
  
  
  We searched the Food and Drug Administration Adverse Event Reporting System for reports of chemical leukoderma associated with MTS, received by the Food and Drug Administration from April 6, 2006 to December 23, 2014.
  
  
  
  We identified 51 cases of chemical leukoderma reported with the use of MTS. The median age was 11 years; 43 cases reported leukoderma at or near the application site only, and 7 reported leukoderma at other parts of the body in addition to the application site; 1 case did not provide enough information to confirm the affected site. The time to onset ranged from 2 months to 4 years after the initiation of MTS. MTS was discontinued in 31 cases. Thirteen patients were prescribed treatment for repigmentation. Three cases reported continued spread of leukoderma after MTS was discontinued. Nineteen cases were diagnosed as vitiligo, including 5 cases reporting histologic features consistent with vitiligo. Leukoderma was persistent in all cases. The median follow-up interval after the discontinuation of MTS in 23 cases was 14 months.
  
  
  
  As outlined in recent changes to the prescribing information for MTS, health care professionals need to be aware of the potential risk of chemical leukoderma caused by MTS, especially given that chemical leukoderma is often misdiagnosed as idiopathic vitiligo. MTS should be discontinued at the earliest sign of pigment loss and other treatment options considered.
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Electronic address: Carmen.Cheng@fda.hhs.gov.
authors.forename: Carmen
authors.initials: C
authors.lastname: Cheng
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Lois
authors.initials: L
authors.lastname: La Grenade
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Ida-Lina
authors.initials: IL
authors.lastname: Diak
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Allen
authors.initials: A
authors.lastname: Brinker
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Levin
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000697:Central Nervous System Stimulants / Q000009:adverse effects*; D002648:Child; D003875:Drug Eruptions / Q000209:etiology*; D005260:Female; D006801:Humans; D017496:Hypopigmentation / Q000139:chemically induced*; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects*; D057968:Transdermal Patch; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate
keywords: attention deficit hyperactivity disorder; depigmentation; hypopigmentation; skin discoloration; vitiligo