Toward Improved Pregnancy Labelling
Main Article Content
Keywords
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Abstract
Information about the use of a medication in pregnancy is part of overall drug labelling as prepared by the pharmaceutical company and approved by the regulators. It is aimed at assisting clinicians in prescribing, however, very few drugs are labelled for specific indications in pregnancy, since there is rarely information about the use of a drug in this condition. Recently the FDA has drafted new guidelines for the labeling of drugs in pregnancy and breastfeeding, to replace the A,B,C,D,X system that was used for more than 30 years. Here we document the use of the new system through 3 different medications; each representing a different clinical situation in pregnancy- acute infection, chronic pain, and drug use during labor. Advantages and challenges in the new system are being highlighted.
References
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25. Plaut MM, Schwartz ML, Lubarsky SL. Uterine rupture associated with the use of misoprostol in the gravid patient with a previous cesarean section. AmJ Obstet Gynecol 1999;180(6 Pt 1):1535-42.
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28. Schick B, HomM, Tolosa J, Lobrizzi R, Donnenfeld A. Preliminary analysis of first trimester exposure to oxycodone and hydrocodone (Abstract). Reprod Toxicol 1996;10:162.
29. Sithisarn T, Bada HS, Dai H, Reinhardt CR, Randall DC, Legan SJ. Effects of perinatal oxycodone exposure on the response to CRH in late adolescent rats. Neurotoxicol Teratol 2008;30:118-124.
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2. Nulman I, Rovet J, Stewart DE, et al. Child development following exposure to tricyclic antidepressants or fluoxetine throughout fetal life: a prospective, controlled study. AmJ Psychiatry 2002;159 (11):1889-95.
3. Einarson A, Selby P, Koren G. Abrupt discontinuation of psychotropic drugs during pregnancy: fear of teratogenic risk and impact of counselling. J Psychiatry Neurosci 2001;26(1):44-8.
4. Heinonen OP, Slone D, Monson RR, Hook EB, Shapiro S. Cardiovascular birth defects and antenatal exposure to female sex hormones. N Engl JMed 1977;296(2):67-70.
5. Harris JW. Influenza occurring in pregnant women: a statistical study of thirteen hundred and fifty cases. JAMA 1919;72:978-80.
6. Freeman DW, Barno A. Deaths from Asian influenza associated with pregnancy. Am J Obstet Gynecol 1959;78:1172-5.
7. Ward P, Small I, Smith J, Suter P, Dutkowski R. Oseltamivir (Tamiflu) and its potential for use in the event of an influenza pandemic. J Antimicrob Chemother 2005;55(Suppl 1):15-21.
8. The ANZIC influenza Investigators. Critical Care Service and 2009 H1N1 influenza in Australia and New Zealand. N Engl JMed 2009;361. DOI: 10.1056/NEJMoa0908481.
9. Jain S, Kamimoto K, Bramley AM for the 2009 Pandemic Influenza A (H1N1) Virus Hospitalizations Investigation Team. Hospitalized Patients with 2009 H1N1 Influenza in the United States, April-June 2009. N Engl J Med 2009;361. DOI: 10.1056/NEJMoa0906695.
10. Worley KC, Roberts SW, Bawdon RE. The metabolism and transplacental transfer of oseltamivir in the ex vivo human model. Infect Dis Obstet Gynecol 2008; 2008:927574. DOI: 10.1155/2008/927574.
11. Tanaka T, Nakajima K, Murashima A, et al. Safety of neuraminidase inhibitors against novel influenza A (H1N1) in pregnant and breastfeeding women. CanMed Assoc J. 2009;181(1-2):55-8.
12. ACOG Committee on Practice Bulletins - Obstetrics. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol 2009;114(2 Pt 1):386-97. DOI: 10.1097/AOG.0b013e3181b48ef5.
13. Chuck FJ, Huffaker BJ. Labor induction with intravaginal misoprostol versus intracervical prostaglandin E2 gel (Prepidil gel): randomized comparison. AmJ Obstet Gynecol 1995;173(4):1137-42. 14. HenrichW, Dudenhausen JW, Hanel C, Chen FC. Oral misoprostol against vaginal dinoprostone for labor induction at term: a randomized comparison. Z Geburtshilfe Neonatol 2008;212(5):183-8. 15. Ozkan S, Cali?kan E, Do?er E, Yücesoy I, Ozeren S, Vural B. Comparative efficacy and safety of vaginal misoprostol versus dinoprostone vaginal insert in labor induction at term: a randomized trial. Arch Gynecol Obstet 2009;280(1):19-24.
16. Kolderup L, McLean L, Grullon K, Safford K, Kilpatrick SJ.Misoprostol is more efficacious for labor induction than prostaglandin E2, but is it associated with more risk? AmJ Obstet Gynecol 1999; 180(6 Pt 1):1543-50.
17. Wing DA; Misoprostol Vaginal Insert Consortium. Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial. Obstet Gynecol 2008;112(4):801-12.
18. Nagpal MB, Raghunandan C, Saili A. Oral misoprostol versus intracervical prostaglandin E2 gel for active management of premature rupture of membranes at term. Int J Gynaecol Obstet 2009;106(1):23-6.
19. Krithika KS, Aggarwal N, Suri V. Prospective randomised controlled trial to compare safety and efficacy of intravaginal Misoprostol with intracervical Cerviprime for induction of labour with unfavourable cervix. J Obstet Gynaecol 2008;28(3):294-7.
20. Sanchez-Ramos L, Kaunitz AM, Del Valle GO, Delke I, Schroeder PA, Briones DK. Labor induction with the prostaglandin E1 methyl analoguemisoprostol versus oxytocin: a randomized trial. Obstet Gynecol 1993;81(3):332-6.
21. Mundle WR, Young DC. Vaginal misoprostol for induction of labor: a randomized controlled trial. Obstet Gynecol 1996;88(4 Pt 1):521-5.
22. MarguliesM, Campos Pérez G, Voto LS.Misoprostol to induce labour. Lancet 1992;339(8784):64.
23. Kundodyiwa TW, Alfirevic Z, Weeks AD. Low-dose oral misoprostol for induction of labor: a systematic review. Obstet Gynecol 2009;113(2 Pt 1):374-83.
24. Blanchette HA, Nayak S, Erasmus S. Comparison of the safety and efficacy of intravaginal misoprostol (prostaglandin E1) with those of dinoprostone (prostaglandin E2) for cervical ripening and induction of labor in a community hospital. AmJ Obstet Gynecol 1999;180(6 Pt 1):1551-9.
25. Plaut MM, Schwartz ML, Lubarsky SL. Uterine rupture associated with the use of misoprostol in the gravid patient with a previous cesarean section. AmJ Obstet Gynecol 1999;180(6 Pt 1):1535-42.
26. Rao R, Desai NS. OxyContin and neonatal abstinence syndrome. J Perinatol 2002;22:324-5.
27. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. Eighth edition. Philadelphia, PA: LippincottWilliams &Wilkins, 2008.
28. Schick B, HomM, Tolosa J, Lobrizzi R, Donnenfeld A. Preliminary analysis of first trimester exposure to oxycodone and hydrocodone (Abstract). Reprod Toxicol 1996;10:162.
29. Sithisarn T, Bada HS, Dai H, Reinhardt CR, Randall DC, Legan SJ. Effects of perinatal oxycodone exposure on the response to CRH in late adolescent rats. Neurotoxicol Teratol 2008;30:118-124.
30. ElectronicMedicines Compendium(eMC). OxyNorm10 mg/ml solution for injection or infusion. Napp Pharmaceuticals Limited 2008. (2010) http://emc.medicines.org.uk/medicine/12151/SPC/OxyNorm+10+mg+ml+solution+for+injection+or+infusion/#PRECLINICAL_SAFETYProduct information (September 15, 2010).