Risk management strategies in the Physicians' Desk Reference product labels for pregnancy category X drugs

Drug Safety

Volumn 25, Issue 12, 2002, Pages 885-892

  Uhl, Kathleen ^a   Kennedy, Dianne L ^a   Kweder, Sandra L ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ANDROGEN; ANTIMETABOLITE; ANTIVIRUS AGENT; ARTHROTEC; BENZODIAZEPINE DERIVATIVE; BEXAROTENE; DRUG; ERGOTAMINE; ETRETIN; GOSERELIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; ISOTRETINOIN; LEFLUNOMIDE; MISOPROSTOL; REBETRON; RECOMBINANT ALPHA2B INTERFERON; RETINOID; RIBAVIRIN; TAZAROTENE; TERATOGENIC AGENT; THALIDOMIDE;

ARTICLE; CONTRACEPTION; DRUG CLASSIFICATION; DRUG CONTRAINDICATION; DRUG INDICATION; DRUG INFORMATION; DRUG LABELING; DRUG PROGRAM; FOOD AND DRUG ADMINISTRATION; PREGNANCY; PREGNANCY TEST; PRIORITY JOURNAL; RISK MANAGEMENT; TERATOGENICITY;

EID: 0036395265     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200225120-00006     Document Type: Article

References (14)

1. Pregnancy labeling. FDA Drug Bull 1979; 9 (4): 23-4
2. Weiss S, Vega A, McCloskey C, et al. Drug use in pregnancy: prescription drug use during pregnancy among women in Kaiser Permanente Northwest, 1993-1994. Report to the Office of Women's Health, US FDA, 1997 Oct 7
3. Lacroix I, Damase-Michel C, Lapeyre-Mestre M, et al. Prescription of drugs during pregnancy in France. Lancet 2000 Nov; 356 (9243): 1735-6
4. Olesen C, Sorensen HT, Jong-Van Den Berg LD, et al. Prescribing during pregnancy and lactation with reference to the Swedish classification system: a populations-based study among Danish women. Acta Obstet Gynecol Scand 1999 Sep; 78 (8): 686-92
5. Cohen JS, Insel PA. The Physicians' Desk Reference: problems and possible improvements. Arch Intern Med 1996 Jul; 156 (13): 1375-80
6. Hatton RC, Doering PL, Frias JL. Physicians' sources of information about teratogenic effects of drugs. Drug Inf J 1982 Jul-Sep; 16 (3): 148-53
7. Physicians' Desk Reference. Suppl. B. 55th ed. Montvale (NJ): Medical Economics Company Inc, 2001
8. Friedman JM, Polifka JE. Teratogenic effects of drugs: a resource for clinicians (TERIS). 2nd ed. Baltimore (MD): The Johns Hopkins University Press, 2000
9. Scialli AR. A clinical guide to reproductive and development toxicology. Boca Raton (FL): CRC Press Inc, 1992
10. Sanz E, Gomes-Lopez T, Martinez-Quintas MJ. Perception of teratogenic risk of common medicines. Eur J Obstet Gynecol Reprod Biol 2001 Mar; 95 (1): 127-31
11. Koren G, Bologa M, Long D, et al. Perception of teratogenic risk by pregnant women exposed to drugs and chemical during the first trimester. Am J Obstet Gynecol 1989 Aug; 160 (5 Pt 1): 1190-204
12. Department of Health and Human Services, Food and Drug Administration. Requirements on content and format of labeling for human prescription drugs and biologics: requirements for prescription drug product labels. Fed Regist 2000 Dec; 65 (247): 81082-131
13. Department of Health and Human Services, Food and Drug Administration (FDA). Content and format of labeling for human prescription drugs, pregnancy labeling, public hearing - FDA: notice of public hearing, request for comments. Fed Regist 1997; 62: 41061-3
14. Boothby LA, Doering PL. FDA labeling system for drugs in pregnancy. Ann Pharmacother 2001 Nov; 35 (11): 1485-9