PMID- 22697192
OWN - NLM
STAT- MEDLINE
DCOM- 20120829
LR  - 20151119
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 73
IP  - 5
DP  - 2012 May
TI  - Safety of selegiline transdermal system in clinical practice: analysis of adverse 
      events from postmarketing exposures.
PG  - 661-8
LID - 10.4088/JCP.12m07648 [doi]
AB  - 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). 
      METHOD: 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.
CI  - (c) Copyright 2012 Physicians Postgraduate Press, Inc.
FAU - Pae, Chi-Un
AU  - Pae CU
AD  - Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 
      Durham, North Carolina 27705, USA.
FAU - Bodkin, J Alexander
AU  - Bodkin JA
FAU - Portland, Kimberly Blanchard
AU  - Portland KB
FAU - Thase, Michael E
AU  - Thase ME
FAU - Patkar, Ashwin A
AU  - Patkar AA
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Monoamine Oxidase Inhibitors)
RN  - 2K1V7GP655 (Selegiline)
RN  - X8ZC7V0OX3 (Tyramine)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/statistics & numerical data
MH  - Aged
MH  - Depressive Disorder/*drug therapy
MH  - Drug Eruptions/etiology
MH  - Drug Interactions
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - *Food-Drug Interactions
MH  - Humans
MH  - Hypertension/chemically induced/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Monoamine Oxidase Inhibitors/*administration & dosage/adverse effects
MH  - Selegiline/*administration & dosage/adverse effects
MH  - Self-Injurious Behavior/chemically induced
MH  - Tyramine/*adverse effects
MH  - United States
EDAT- 2012/06/16 06:00
MHDA- 2012/08/30 06:00
CRDT- 2012/06/16 06:00
PHST- 2012/01/12 00:00 [received]
PHST- 2012/03/28 00:00 [accepted]
PHST- 2012/06/16 06:00 [entrez]
PHST- 2012/06/16 06:00 [pubmed]
PHST- 2012/08/30 06:00 [medline]
AID - 10.4088/JCP.12m07648 [doi]
PST - ppublish
SO  - J Clin Psychiatry. 2012 May;73(5):661-8. doi: 10.4088/JCP.12m07648.