Safety of selegiline transdermal system in clinical practice: Analysis of adverse events from postmarketing exposures

Journal of Clinical Psychiatry

Volumn 73, Issue 5, 2012, Pages 661-668

  Pae, Chi Un ^a,b   Bodkin, J Alexander ^c   Portland, Kimberly Blanchard ^d   Thase, Michael E ^e   Patkar, Ashwin A ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b The Catholic University of Korea College of Medicine   (South Korea)

^c MCLEAN HOSPITAL   (United States)

^d Mylan Specialty LP   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALCOHOL; AMPHETAMINE; CALCIUM; CLOMIPRAMINE; CYCLOBENZAPRINE; ELETRIPTAN; FLUTICASONE; LEVODOPA; LEVOFLOXACIN; LITHIUM SULFATE; METHYLPHENIDATE; MODAFINIL; PRAMIPEXOLE; SALMETEROL; SCOPOLAMINE; SELEGILINE; TAMSULOSIN; TOPIRAMATE; TRANYLCYPROMINE; TRAZODONE; VALACICLOVIR;

ADULT; AGED; AGITATION; APPLICATION SITE RASH; APPLICATION SITE REACTION; ARTICLE; ATAXIA; BALANCE DISORDER; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL PRACTICE; CONFUSION; CONNECTIVE TISSUE DISEASE; CONSCIOUSNESS DISORDER; CONTROLLED STUDY; CONVULSION; DELIRIUM; DEPRESSION; DISEASE CLASSIFICATION; DISORIENTATION; DIZZINESS; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; EYE DISEASE; FALLING; FATIGUE; FEMALE; FOCAL EPILEPSY; FOOD AND DRUG ADMINISTRATION; GALACTORRHEA; GASTROINTESTINAL DISEASE; HEART ARRHYTHMIA; HEART DISEASE; HEART INFARCTION; HEART RATE; HUMAN; HYPERTENSION; HYPOMANIA; INSOMNIA; INTOXICATION; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; MANIA; MEDIASTINUM DISEASE; MENSTRUATION DISORDER; METABOLIC DISORDER; MIGRAINE; MUSCLE SPASM; MUSCLE STIFFNESS; MUSCULOSKELETAL DISEASE; NAUSEA; NERVOUSNESS; NIGHT SWEAT; NUTRITIONAL DISORDER; ORTHOSTATIC HYPOTENSION; PAIN; PARESTHESIA; PATHOLOGICAL GAMBLING; POLYMENORRHEA; POSITIONAL DIZZINESS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RESPIRATORY TRACT DISEASE; RESTLESSNESS; SIDE EFFECT; SKIN DISEASE; SOMNOLENCE; SUICIDE ATTEMPT; SYNCOPE; THORAX DISEASE; TRANSDERMAL PATCH; UNITED STATES; VASCULAR DISEASE; VISUAL IMPAIRMENT;

EID: 84861828694     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.12m07648     Document Type: Article

References (25)

1. Amsterdam JD, Chopra M. Monoamine oxidase inhibitors revisited. Psychiatr Ann. 2001;31:361-370.
2. Cascade EF, Kalali AH, Thase ME. Use of antidepressants: expansion beyond depression and anxiety. Psychiatry (Edgmont). 2007;4(12):25-28. PubMed
3. Amsterdam JD. A double-blind, placebo-controlled trial of the safety and efficacy of selegiline transdermal system without dietary restrictions in patients with major depressive disorder. J Clin Psychiatry. 2003;64(2): 208-214. doi:10.408/JCP.v64n0216 PubMed (Pubitemid 36268325)
4. Bodkin JA, Amsterdam JD. Transdermal selegiline in major depression: a double-blind, placebo-controlled, parallel-group study in outpatients. Am J Psychiatry. 2002;159(11):1869-1875. doi:10.176/api.ajp.159.1.1869 PubMed (Pubitemid 35283252)
5. Feiger AD, Rickels K, Rynn MA, et al. Selegiline transdermal system for the treatment of major depressive disorder: an 8-week, double-blind, placebo-controlled, flexible-dose titration trial. J Clin Psychiatry. 2006;67(9):1354-1361. doi:10.408/JCP.v67n0905 PubMed (Pubitemid 44583382)
6. Amsterdam JD, Bodkin JA. Selegiline transdermal system in the prevention of relapse of major depressive disorder: a 52-week, double-blind, placebo-substitution, parallel-group clinical trial. J Clin Psychopharmacol. 2006;26(6):579-586. doi:10.1097/01.jcp.0239794.37073.70 PubMed (Pubitemid 44772734)
7. Robinson DS, Amsterdam JD. The selegiline transdermal system in major depressive disorder: a systematic review of safety and tolerability. J Affect Disord. 2008;105(1-3):15-23. doi:10.1016/j.jad.207.04.024 PubMed (Pubitemid 350236356)
8. Azzaro AJ, Vandenberg CM, Blob LF, et al. Tyramine pressor sensitivity during treatment with the selegiline transdermal system 6 mg/24 h in healthy subjects. J Clin Pharmacol. 2006;46(8):933-944. doi:10.17/0912706289852 PubMed (Pubitemid 44050830)
9. Woodcock J, Behrman RE, Dal Pan GJ. Role of postmarketing surveillance in contemporary medicine. Annu Rev Med. 2011;62(1): 1-10. doi:10.146/anurev-med- 060309-16431 PubMed
10. MedDRA Maintenance and Support Services Organization. Introductory Guide, MedDRA Version 14.0. http://www.who.int/medical-devices/innovation/ MedDRAintroguide-version14-0-March2011.pdf. Published March 2011.
11. Food and Drug Administration. What is a serious adverse event? Food and Drug Administration Web site. http://www.fda.gov/safety/medwatch/howtoreport/ ucm053087.htm. Updated June 23, 2011. Accessed April 13, 2012.
12. EMSAM [package insert]. Napa, CA: Dey Pharma; 2009.
13. Papadopoulos DP, Mourouzis I, Thomopoulos C, et al. Hypertension crisis. Blood Press. 2010;19(6):328-336. doi:10.3109/08037051.2010.48052 PubMed
14. Teicher MH, Glod CA, Cole JO. Antidepressant drugs and the emergence of suicidal tendencies. Drug Saf. 1993;8(3):186-212. doi:10.2165/02018-19308030-02 PubMed (Pubitemid 23123065)
15. Pae CU, Lim HK, Han C, et al. Selegiline transdermal system: current awareness and promise. Prog Neuropsychopharmacol Biol Psychiatry. 2007;31(6):1153-1163. doi:10.1016/j.pnpbp.207.04.020 PubMed (Pubitemid 47082533)
16. Patkar AA, Pae CU, Masand PS. Transdermal selegiline: the new generation of monoamine oxidase inhibitors. CNS Spectr. 2006; 11(5):363-375. PubMed (Pubitemid 43727136)
17. Patkar AA, Pae CU, Zarzar M. Transdermal selegiline. Drugs Today (Barc). 2007;43(6):361-377. doi:10.1358/dot.207.43.6.1050794 PubMed (Pubitemid 47234769)
18. Lépine JP, Briley M. The increasing burden of depression. Neuropsychiatr Dis Treat. 2011;7(suppl 1):3-7. PubMed
19. Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting System (WISQARS). http://www.cdc.gov/injury/wisqars/index. html. 2007.
20. Hilton S, Jaber B, Ruch R. Moclobemide safety: monitoring a newly developed product in the 1990s. J Clin Psychopharmacol. 1995; 15(suppl 2):76S-83S. doi:10.1097/04714-1950801-013 PubMed
21. Gibbons RD, Amatya AK, Brown CH, et al. Post-approval drug safety surveillance. Annu Rev Public Health. 2010;31(1):419-437. doi:10.146/anurev. publhealth.012809.103649 PubMed
22. Wang HW, Hochberg AM, Pearson RK, et al. An experimental investigation of masking in the US FDA Adverse Event Reporting System database. Drug Saf. 2010;33(12):1117-1133. doi:10.2165/1584390-0-0 PubMed
23. Abou Chakra CN, Pariente A, Pinet M, et al. Case series in drug safety: a review to determine characteristics and quality. Drug Saf. 2010;33(12): 1081-1088. doi:10.2165/153930-0-0 PubMed
24. Weaver J, Willy M, Avigan M. Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. AAPS J. 2008; 10(1):35-41. doi:10.1208/s1248-07-904-5 PubMed
25. Roller ST, Pippins RR, Ngai JW. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment. Food Drug Law J. 2009;64(3):577-598. PubMed