Safety of selegiline transdermal system in clinical practice: analysis of adverse events from postmarketing exposures.
OBJECTIVE
The objective of this analysis is to present the safety profile of selegiline transdermal system (STS) in clinical practice after US Food and Drug Administration approval by analyzing reported postmarketing adverse events (AEs).


METHODS
Deidentified data were obtained on AEs, regardless of causality, as collected and compiled in the pharmaceutical company's adverse event collection systems/databases after the launch of STS in the United States. All reports of hypertensive crisis, suicide attempts, and STS overdoses were carefully examined to independently determine relation of the AE to STS.


RESULTS
From April 2006 to October 2010, a total of 3,155 AEs in 1,516 patients were reported (5.2% of the total exposures; N = 29,141), regardless of causality. The most frequently reported categories of AEs were general disorders (no. of AEs = 1,037, 3.6%) and central nervous system (CNS) disorders (no. of AEs = 574, 2.0%). A total of 266 reports (0.9%) were classified as serious AEs; CNS disorders (no. of AEs = 71, 26.7%) and cardiac and vascular disorders (no. of AEs = 44, 16.5%) were most common. There were 13 self-reports of possible hypertensive events or hypertension, although objective clinical data were not submitted in any of these cases. Thirteen drug-drug interactions (0.04%) were reported, and 5 were classified as serious.


CONCLUSIONS
The most commonly reported AEs were application site reactions and insomnia. Very few patients reported a hypertensive event, and there were no objectively confirmed reports of hypertensive crisis with food at any STS dose. Therapeutic doses of STS appear to have a safety profile in clinical practice that is consistent with that observed in clinical trials. However, given the relatively modest exposure numbers, continued safety monitoring is recommended.
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina 27705, USA.
Chi-Un
CU
Pae
J Alexander
JA
Bodkin
Kimberly Blanchard
KB
Portland
Michael E
ME
Thase
Ashwin A
AA
Patkar
D000279:Administration, Cutaneous; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000368:Aged; D003866:Depressive Disorder / Q000188:drug therapy*; D003875:Drug Eruptions / Q000209:etiology; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D018565:Food-Drug Interactions; D006801:Humans; D006973:Hypertension / Q000139:chemically induced / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012642:Selegiline / Q000008:administration & dosage* / Q000009:adverse effects; D016728:Self-Injurious Behavior / Q000139:chemically induced; D014439:Tyramine / Q000009:adverse effects*; D014481:United States
D008996:Monoamine Oxidase Inhibitors; D012642:Selegiline; D014439:Tyramine