Drug safety: Pregnancy rating classifications and controversies

Clinics in Dermatology

Volumn 34, Issue 3, 2016, Pages 401-409

  Wilmer, Erin ^a   Chai, Sandy ^a   Kroumpouzos, George ^a  

^a BROWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADAPALENE; ANTIHISTAMINIC AGENT; ANTIINFECTIVE AGENT; ANTIMALARIAL AGENT; ANTIPARASITIC AGENT; AZATHIOPRINE; BENZOYL PEROXIDE; CORTICOSTEROID; CYCLOSPORIN; IMMUNOGLOBULIN; RETINOIC ACID; RETINOID; RITUXIMAB; SALICYLIC ACID; SULFA SODIUM SULFACETAMIDE; SULFACETAMIDE; TAZAROTENE; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; UNCLASSIFIED DRUG; USTEKINUMAB; BIOLOGICAL PRODUCT; DRUG; IMMUNOSUPPRESSIVE AGENT;

ADEC CLASSIFICATION SYSTEM; ARTICLE; DATA ANALYSIS; DISEASE ASSOCIATION; DRUG CLASSIFICATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG USE; EVIDENCE BASED MEDICINE; EVIDENCE BASED MEDICINE CLASSIFICATION SYSTEM; FASS CLASSIFICATION SYSTEM; FOOD AND DRUG ADMINISTRATION; FOOD AND DRUG ADMINISTRATION CLASSIFICATION SYSTEM; HUMAN; INFORMATION PROCESSING; INFORMATION SYSTEM; INTERMETHOD COMPARISON; INTERNATIONAL PREGNANCY RATING CLASSIFICATION SYSTEM; OUTCOME ASSESSMENT; PREGNANCY DISORDER; PRIORITY JOURNAL; RISK ASSESSMENT; RISK FACTOR; SKIN DISEASE; SYSTEMIC THERAPY; ADVERSE DRUG REACTION; AUSTRALIA; CLASSIFICATION; COMPARATIVE STUDY; CONTRAINDICATIONS; DRUG LABELING; FEMALE; LACTATION; LEGISLATION AND JURISPRUDENCE; PREGNANCY; PREGNANCY COMPLICATIONS; SKIN DISEASES; SWEDEN; UNITED STATES;

ADRENAL CORTEX HORMONES; ANTI-INFECTIVE AGENTS; AUSTRALIA; BIOLOGICAL PRODUCTS; DRUG LABELING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EVIDENCE-BASED MEDICINE; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LACTATION; PHARMACEUTICAL PREPARATIONS; PREGNANCY; PREGNANCY COMPLICATIONS; RETINOIDS; SKIN DISEASES; SWEDEN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84971376535     PISSN: 0738081X     EISSN: 18791131     Source Type: Journal    
DOI: 10.1016/j.clindermatol.2016.02.013     Document Type: Article

References (58)

1. Mitchell A.A., Gilboa S.M., Werler M.M., et al. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol 2011, 205:51.e51-51.e58.
2. Society PACotT Teratology public affairs committee position paper: pregnancy labeling for prescription drugs: ten years later. Birth Defects Res A Clin Mol Teratol 2007, 79:627-630.
3. Addis A., Sharabi S., Bonati M. Risk classification systems for drug use during pregnancy: are they a reliable source of information?. Drug Saf 2000, 23:245-253.
4. Schaefer C., Peters P., Miller R.K. Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment 2007, Elsevier Academic Press, London, UK. 2nd ed.
5. Charlton R.A., Cunnington M.C., de Vries C.S., et al. Data resources for investigating drug exposure during pregnancy and associated outcomes: the General Practice Research Database (GPRD) as an alternative to pregnancy registries. Drug Saf 2008, 31:39-51.
6. Sannerstedt R., Lundborg P., Danielsson B.R., et al. Drugs during pregnancy: an issue of risk classification and information to prescribers. Drug Saf 1996, 14:69-77.
7. Adam M.P., Polifka J.E., Friedman J.M. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet 2011, 157(C):175-182.
8. Scialli A.R. Animal studies and human risk. Reprod Toxicol 1993, 7:533-534.
9. Peters S.L., Lind J.N., Humphrey J.R., et al. Safe lists for medications in pregnancy: inadequate evidence base and inconsistent guidance from Web-based information, 2011. Pharmacoepidemiol Drug Saf 2013, 22:324-328.
10. Millsop J.W., Heller M.M., Murase J.E. Safety classification systems used in dermatological medication risk counseling of pregnant and lactating patients: a case for an evidence-based approach. Dermatol Ther 2013, 26:347-353.
11. US Food and Drug Administration Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Fed Regist 2008, 73:30831-30868.
12. Mutyambizi K., Mackool B.T. Drug safety. Text Atlas of Obstetric Dermatology 2013, 217-250. Lippincott Williams & Wilkins, Philadelphia, PA. G. Kroumpouzos (Ed.).
13. Wong J.W., Heller M.M., Murase J.E. Caution advised in interpretation of US FDA risk classification for dermatological medications during pregnancy. Dermatol Online J 2012, 18:15.
14. FDA classification of drugs for teratogenic risk. Teratology Society Public Affairs Committee. Teratology 1994, 49:446-447.
15. US Food and Drug Administration Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Fed Regist 2014, 79:72064-72103.
16. Danesh M.J., Murase J.E. The new US Food and Drug Administration pregnancy and lactation labeling rules: their impact on clinical practice. J Am Acad Dermatol 2015, 73:310-311.
17. Mosley J.F., Smith L.L., Dezan M.D. An overview of upcoming changes in pregnancy and lactation labeling information. Pharm Pract (Granada) 2015, 13:605.
18. Australian Government Dept of Health Australian categorisation system for prescribing medicines in pregnancy [Accessed July 2, 2015]. https://www.tga.gov.au/node/4013.
19. Berglund F., Flodh H., Lundborg P., Prame B., Sannerstedt R. Drug use during pregnancy and breast feeding. A classification system for drug information. Acta Obstet Gynecol Scand Suppl 1984, 126:1-55.
20. Chi C.C., Mayon-White R.T., Wojnarowska F.T. Safety of topical corticosteroids in pregnancy: a population-based cohort study. J Invest Dermatol 2011, 131:884-891.
21. LLC S-AUS Plaquenil: hydroxychloroquine sulfate USP [Accessed July 20, 2015]. http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf.
22. Murase J.E., Heller M.M., Butler D.C. Safety of dermatologic medications in pregnancy and lactation: part I. Pregnancy. J Am Acad Dermatol 2014, 70:401.e401-401.e414.
23. Abarientos C., Sperber K., Shapiro D.L., et al. Hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis and its safety in pregnancy. Expert Opin Drug Saf 2011, 10:705-714.
24. Clowse M.E., Magder L., Witter F., et al. Hydroxychloroquine in lupus pregnancy. Arthritis Rheum 2006, 54:3640-3647.
25. Leroux M., Desveaux C., Parcevaux M., et al. Impact of hydroxychloroquine on preterm delivery andintrauterine growth restriction in pregnant women with systemic lupus erythematosus: a descriptive cohort study. Lupus 2015, 24:1384-1391.
26. Kroumpouzos G., Draelos Z. Skin care products, cosmetics and cosmeceuticals. Text Atlas of Obstetric Dermatology 2013, 251-257. Lippincott Williams & Wilkins, Philadelphia, PA. G. Kroumpouzos (Ed.).
27. Thornton Y.S., Bowe E.T. Neonatal hyperbilirubinemia after treatment of maternal leprosy. South Med J 1989, 82:668.
28. Schwarz E.B., Moretti M.E., Nayak S., et al. Risk of hypospadias in offspring of women using loratadine during pregnancy: a systematic review and meta-analysis. Drug Saf 2008, 31:775-788.
29. Klinger G., Morad Y., Westall C.A., et al. Ocular toxicity and antenatal exposure to chloroquine or hydroxychloroquine for rheumatic diseases. Lancet 2001, 358:813-814.
30. Osadchy A., Ratnapalan T., Koren G. Ocular toxicity in children exposed in utero to antimalarial drugs: review of the literature. J Rheumatol 2011, 38:2504-2508.
31. Garner P., Gulmezoglu A.M. Drugs for preventing malaria in pregnant women. Cochrane Database Syst Rev 2006, 4:CD000169.
32. Friedman S.J. Lindane neurotoxic reaction in nonbullous congenital ichthyosiform erythroderma. Arch Dermatol 1987, 123:1056-1058.
33. Pacqué M., Munoz B., Poetschke G., et al. Pregnancy outcome after inadvertent ivermectin treatment during community-based distribution. Lancet 1990, 336:1486-1489.
34. Mishkin D.S., Van Deinse W., Becker J.M., et al. Successful use of adalimumab (humira) for crohn's disease in pregnancy. Inflamm Bowel Dis 2006, 12:827-828.
35. Berthelot J.M., De Bandt M., Goupille P., et al. Exposition to anti-TNF drugs during pregnancy: outcome of 15 cases and review of the literature. Joint Bone Spine 2009, 76:28-34.
36. Yiu Z.Z., Griffiths C.E., Warren R.B. Safety of biological therapies for psoriasis: effects on reproductive potential and outcomes in male and female patients. Br J Dermatol 1713, 2014:485-491.
37. Babalola O., Strober B.E. Management of psoriasis in pregnancy. Dermatol Ther 2013, 26:285-292.
38. Barbhaiya M., Bermas B.L. Evaluation and management of systemic lupus erythematosus and rheumatoid arthritis during pregnancy. Clin Immunol 2013, 149:225-235.
39. Carmichael S.L., Shaw G.M., Ma C., et al. Maternal corticosteroid use and orofacial clefts. Am J Obstet Gynecol 2007, 197:585.e1-585.e7. [discussion 683-4, e1-7].
40. Park-Wyllie L., Mazzotta P., Pastuszak A., et al. Birth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies. Teratology 2000, 62:385-392.
41. Hviid A., Molgaard-Nielsen D. Corticosteroid use during pregnancy and risk of orofacial clefts. CMAJ 2011, 183:796-804.
42. Czeizel A.E., Rockenbauer M. Population-based case-control study of teratogenic potential of corticosteroids. Teratology 1997, 56:335-340.
43. Mygind H., Thulstrup A.M., Pedersen L., et al. Risk of intrauterine growth retardation, malformations and other birth outcomes in children after topical use of corticosteroid in pregnancy. Acta Obstet Gynecol Scand 2002, 813:234-239.
44. Edwards M.J., Agho K., Attia J., et al. Case-control study of cleft lip or palate after maternal use of topical corticosteroids during pregnancy. Am J Med Genet A 2003, 120(A):459-463.
45. Mahe A., Perret J., Dumont A., et al. The cosmetic use of skin-lightening products during pregnancy in Dakar, Senegal: a common and potentially hazardous practice. Trans R Soc Trop Med Hyg 2007, 101:183-187.
46. Chi C.C., Wang S.H., Mayon-White R., et al. Pregnancy outcomes after maternal exposure to topical corticosteroids: a UK population-based cohort study. JAMA Dermatol 2013, 149:1274-1280.
47. Lamarque V., Leleu M.F., Monka C., et al. Analysis of 629 pregnancy outcomes in transplant recipients treated with sandimmune. Transplant Proc 1997, 29:2480.
48. Paulen M.E., Folger S.G., Curtis K.M., et al. Contraceptive use among solid organ transplant patients: a systematic review. Contraception 2010, 82:102-112.
49. Gan D.C., Welsh B., Webster M. Successful treatment of a severe persistent case of pemphigoid gestationis with antepartum and postpartum intravenous immunoglobulin followed by azathioprine. Australas J Dermatol 2012, 531:66-69.
50. Ahmed A.R., Gurcan H.M. Use of intravenous immunoglobulin therapy during pregnancy in patients with pemphigus vulgaris. J Eur Acad Dermatol Venereol 2011, 25:1073-1079.
51. Panchaud A., Csajka C., Merlob P., et al. Pregnancy outcome following exposure to topical retinoids: a multicenter prospective study. J Clin Pharmacol 2012, 52:1844-1851.
52. Loureiro K.D., Kao K.K., Jones K.L., et al. Minor malformations characteristic of the retinoic acid embryopathy and other birth outcomes in children of women exposed to topical tretinoin during early pregnancy. Am J Med Genet A 2005, 136:117-121.
53. Shapiro L., Pastuszak A., Curto G., et al. Safety of first-trimester exposure to topical tretinoin. Lancet 1997, 350:1143-1144.
54. Autret E., Berjot M., Jonville-Bera A.P., et al. Anophthalmia and agenesis of optic chiasma associated with adapalene gel in early pregnancy. Lancet 1977, 350:339.
55. Menter A. Pharmacokinetics and safety of tazarotene. J Am Acad Dermatol 2000, 43:S31-S35.
56. Chamberlain M.J., Reynolds A.L., Yeoman W.B. Medical memoranda. Toxic effect of podophyllum application in pregnancy. Br Med J 1972, 3:391-392.
57. Yeung D., Nacht S., Dan Bucks B.S., et al. Benzoyl peroxide: percutaneous penetration and metabolic disposition. II. Effect of concentration. J Am Acad Dermatol 1983, 9:920-924.
58. Schwarb F.P., Gabard B., Rufli T., et al. Percutaneous absorption of salicylic acid in man after topical administration of three different formulations. Dermatology 1999, 198:44-51.