FDA approval of doxylamine-pyridoxine therapy for use in pregnancy

New England Journal of Medicine

Volumn 370, Issue 12, 2014, Pages 1081-1083

  Slaughter, Shelley R ^a   Hearns Stokes, Rhonda ^a   Van Der Vlugt, Theresa ^a   Joffe, Hylton V ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

BENDECTIN; DOXYLAMINE PLUS PYRIDOXINE;

BIRTH DEFECT; CLINICAL DECISION MAKING; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPEREMESIS GRAVIDARUM; NAUSEA AND VOMITING; PREGNANCY; PREGNANT WOMAN; PRIORITY JOURNAL; QUALITY OF LIFE; RISK BENEFIT ANALYSIS; SHORT SURVEY; TERATOGENICITY;

ANTIEMETICS; CONGENITAL ABNORMALITIES; DICYCLOMINE; DOXYLAMINE; DRUG APPROVAL; DRUG COMBINATIONS; FEMALE; HISTORY, 20TH CENTURY; HUMANS; MORNING SICKNESS; PREGNANCY; PYRIDOXINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84896459279     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1316042     Document Type: Article

References (5)

1. Holmes LB. Teratogen update: bendectin. Teratology 1983;27:277-81. (Pubitemid 13088895)
2. Brent RL. Bendectin: review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen-litigen. Reprod Toxicol 1995;9:337-49.
3. Einarson TR, Leeder JS, Koren G. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm 1988;22:813-24.
4. McKeigue PM, Lamm SH, Linn S, Kutcher JS. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology 1994;50:27-37. (Pubitemid 24246849)
5. Kutcher JS, Engle A, Firth J, Lamm SH. Bendectin and birth defects. II: Ecological analyses. Birth Defects Res A Clin Mol Teratol 2003;67:88-97. (Pubitemid 38222001)