Was risk properly assessed in Carter, et al's safety assessment of tumor necrosis factor antagonists during pregnancy?

Journal of Rheumatology

Volumn 36, Issue 9, 2009, Pages 2122-

  Winger, Edward E ^a   Reed, Jane L ^a  

^a Laboratory for Reproductive Medicine and Immunology   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LEFLUNOMIDE; METHOTREXATE; TUMOR NECROSIS FACTOR INHIBITOR;

CONGENITAL MALFORMATION; DATA BASE; DRUG EXPOSURE; DRUG SURVEILLANCE PROGRAM; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; INCIDENCE; LETTER; PREGNANCY; PRIORITY JOURNAL; RISK ASSESSMENT; RISK FACTOR; SENSITIVITY ANALYSIS;

ABNORMALITIES, DRUG-INDUCED; ANTIRHEUMATIC AGENTS; CONGENITAL ABNORMALITIES; FEMALE; HUMANS; INFANT, NEWBORN; PREGNANCY; RHEUMATIC DISEASES; RISK FACTORS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 70349243949     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: 10.3899/jrheum.090141     Document Type: Letter

References (5)

1. Carter JD, Ladhani A, Ricca LR, Valeriano J, Vasey FB. A safety assessment of tumor necrosis factor antagonists during pregnancy: A review of the Food and Drug Administration database. J Rheumatol 2009;36:635-641
2. Carter JD, Ladhani A, Ricca LR, Valeriano J, Vasey FB. A safety assessment of tumor necrosis factor antagonists during pregnancy: A review of the FDA database [abstract]. Arthritis Rheum 2007;56 Suppl;S286.
3. Rheumatology Rounds, University of Toronto. Safety of anti-TNF alpha agents during pregnancy (slide 69). April 8, 2008 [Internet. Slide presentation. Accessed April 22, 2009.] Available from: http://www.rheumatology.utoronto.ca/ Assets/Rounds/ ICC+April+8th$!2c+2008.pdf; see slide 69.
4. Johns Hopkins Arthritis Center. Physician Corner. Commentary on: A safety assessment of TNF antagonists during pregnancy: A Review of the FDA Database. [Internet. Accessed April 22, 2009.] Available from: http://www.hopkins- arthritis.org/physician-corner/ education/acr2007/rheumatoid-arthritis/abstract- 667.html.
5. US Food and Drug Administration. The Adverse Event Reporting System (AERS). Latest quarterly data files. [Internet. Accessed April 22, 2009.] Available from: http://www.fda.gov/cder/ aers/extract.htm.