FDA approval of paroxetine for menopausal hot flushes

New England Journal of Medicine

Volumn 370, Issue 19, 2014, Pages 1777-1779

  Orleans, Ronald J ^a   Li, Li ^a   Kim, Myong Jin ^a   Guo, Jia ^a   Sobhan, Mahboob ^a   Soule, Lisa ^a   Joffe, Hylton V ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONJUGATED ESTROGEN; GESTAGEN; MONOAMINE OXIDASE INHIBITOR; PAROXETINE; PIMOZIDE; PLACEBO; TAMOXIFEN; THIORIDAZINE;

AKATHISIA; BLEEDING; BREAST CANCER; CEREBROVASCULAR ACCIDENT; CORONARY ARTERY DISEASE; DEEP VEIN THROMBOSIS; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HORMONAL THERAPY; HOT FLUSH; HUMAN; HYPONATREMIA; MENOPAUSE; PATIENT MONITORING; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; SHORT SURVEY; SUICIDAL IDEATION; TREATMENT DURATION; VASOMOTOR DISORDER; VENOUS THROMBOEMBOLISM;

ADVISORY COMMITTEES; ANTINEOPLASTIC AGENTS, HORMONAL; CYTOCHROME P-450 CYP2D6; DRUG APPROVAL; DRUG INTERACTIONS; FEMALE; HOT FLASHES; HUMANS; PAROXETINE; SEROTONIN UPTAKE INHIBITORS; SUICIDAL IDEATION; TAMOXIFEN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84899893780     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1402080     Document Type: Article

References (5)

1. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-33. (Pubitemid 34761611)
2. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004;291:1701-12. (Pubitemid 38489892)
3. Stearns V, Johnson MD, Rae JM, et al. Active tamoxifen metabolite plasma concentrations after coadministration of tamoxifen and the selective serotonin reuptake inhibitor paroxetine. J Natl Cancer Inst 2003;95:1758-64. (Pubitemid 38008898)
4. Hertz DL, McLeod HL, Irvin WJ Jr. Tamoxifen and CYP2D6: a contradiction of data. Oncologist 2012;17:620-30.
5. Zembutsu H, Sasa M, Kiyotani K, Mushiroda T, Nakamura Y. Should CYP2D6 inhibitors be administered in conjunction with tamoxifen? Expert Rev Anticancer Ther 2011;11:185-93.