Page last updated: 2024-10-26

dicyclomine and Pregnancy

dicyclomine has been researched along with Pregnancy in 154 studies

Dicyclomine: A muscarinic antagonist used as an antispasmodic and in urinary incontinence. It has little effect on glandular secretion or the cardiovascular system. It does have some local anesthetic properties and is used in gastrointestinal, biliary, and urinary tract spasms.
dicyclomine : The ester resulting from the formal condensation of 1-cyclohexylcyclohexanecarboxylic acid with 2-(diethylamino)ethanol. An anticholinergic, it is used as the hydrochloride to treat or prevent spasm in the muscles of the gastrointestinal tract, particularly that associated with irritable bowel syndrome.

Pregnancy: The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.

Research Excerpts

ExcerptRelevanceReference
"We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy."9.248-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information. ( Persaud, N; Zhang, R, 2017)
"Doxylamine succinate-pyridoxine hydrochloride delayed release combination is safe and well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating nausea and vomiting of pregnancy."9.20Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2015)
" This was a pre-specified substudy of a randomized, placebo-controlled trial comparing the antiemetic effect of the doxylamine-vitamin B6 combination (Diclectin®) (n = 131) to placebo (n = 126) in women with nausea and vomiting of pregnancy."9.19Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs. ( Caritis, S; Clark, S; Hankins, G; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2014)
"Although Diclectin (doxylamine/pyridoxine delayed-released combination) is widely used in Canada, its pharmacokinetics (PK) during pregnancy has never been described."9.17Comparing the pharmacokinetics of doxylamine/pyridoxine delayed-release combination in nonpregnant women of reproductive age and women in the first trimester of pregnancy. ( Caritis, S; Clark, S; Hankins, G; Koren, G; Matok, I; Miodovnik, M; Umans, J, 2013)
" The authors' objective is to identify the determinants of adherence to delayed-release doxylamine-pyridoxine (Diclectin) in patients with nausea and vomiting of pregnancy (NVP)."9.16Determinants of adherence to delayed-release doxylamine and pyridoxine in patients with nausea and vomiting of pregnancy. ( Caritis, S; Chiossi, G; Clark, S; Costantine, MM; Hankins, GD; Koren, G; Matok, I; Miodovnik, M; Umans, JG, 2012)
"Diclectin delayed release formulation of doxylamine succinate and pyridoxine hydrochloride is effective and well tolerated in treating nausea and vomiting of pregnancy."9.14Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Mattison, DR; Miodovnik, M; Umans, JG, 2010)
"Doxylamine-pyridoxine is the first-line agent for the treatment of nausea and vomiting of pregnancy (NVP) according to Canadian guidelines, and this combination is commonly prescribed to pregnant women."7.80Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy? ( Chin, J; Persaud, N; Walker, M, 2014)
"Diclectin (pyridoxine 10 mg and doxylamine 10 mg) has traditionally been used to treat nausea and vomiting of pregnancy (NVP); however, this drug is unavailable in many countries."7.79Evaluation of the efficacy and safety of bi-daily combination therapy with pyridoxine and doxylamine for nausea and vomiting of pregnancy. ( Ashkenazi-Hoffnung, L; Klinger, G; Merlob, P; Stahl, B, 2013)
"The US FDA approval in April 2013 of Diclegis®, the doxylamine-pyridoxine combination for morning sickness, is a major milestone, particularly since it is indicated for use in pregnancy and the FDA has labeled it a pregnancy category A drug the strongest evidence of fetal safety."7.79The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women. ( Koren, G, 2013)
" The pregnancy was complicated by chronic maternal schizophrenia, severe toxaemia and maternal use of fluphenazine enanthate, dicyclomine hydrochloride, doxylamine succinate, pyridoxine hydrochloride and other drugs."7.66Multiple congenital abnormalities in a newborn boy associated with maternal use of fluphenazine enanthate and other drugs during pregnancy. ( Bury, RG; Donaldson, GL, 1982)
"In a prospective cohort study of 20, 282 gravidas and their offspring, congenital malformation rates were similar in the children of over 1,000 women exposed and those not exposed to two components of Bendectin (doxylamine succinate and dicyclomine hydrochloride) during the first four lunar months of pregnancy."7.65Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score. ( Heinonen, OP; Kaufman, DW; Monson, RR; Shapiro, S; Siskind, V; Slone, D, 1977)
"A four day study drug dosing trial with Diclegis® is sufficient to document efficacy, as the results are similar to those achieved after 14 study drug dosing days."6.82Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2016)
" Pharmacokinetic parameters were calculated for each study period using standard, non-compartmental methods, and differences were assessed using ANOVA."6.78Sex differences in the pharmacokinetics and bioequivalence of the delayed-release combination of doxylamine succinate-pyridoxine hydrochloride; implications for pharmacotherapy in pregnancy. ( Gill, SK; Koren, G; Macleod, S; Vranderick, M, 2013)
"We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy."5.248-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information. ( Persaud, N; Zhang, R, 2017)
"Doxylamine succinate-pyridoxine hydrochloride delayed release combination is safe and well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating nausea and vomiting of pregnancy."5.20Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2015)
" This was a pre-specified substudy of a randomized, placebo-controlled trial comparing the antiemetic effect of the doxylamine-vitamin B6 combination (Diclectin®) (n = 131) to placebo (n = 126) in women with nausea and vomiting of pregnancy."5.19Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs. ( Caritis, S; Clark, S; Hankins, G; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2014)
"Although Diclectin (doxylamine/pyridoxine delayed-released combination) is widely used in Canada, its pharmacokinetics (PK) during pregnancy has never been described."5.17Comparing the pharmacokinetics of doxylamine/pyridoxine delayed-release combination in nonpregnant women of reproductive age and women in the first trimester of pregnancy. ( Caritis, S; Clark, S; Hankins, G; Koren, G; Matok, I; Miodovnik, M; Umans, J, 2013)
" The authors' objective is to identify the determinants of adherence to delayed-release doxylamine-pyridoxine (Diclectin) in patients with nausea and vomiting of pregnancy (NVP)."5.16Determinants of adherence to delayed-release doxylamine and pyridoxine in patients with nausea and vomiting of pregnancy. ( Caritis, S; Chiossi, G; Clark, S; Costantine, MM; Hankins, GD; Koren, G; Matok, I; Miodovnik, M; Umans, JG, 2012)
"Diclectin delayed release formulation of doxylamine succinate and pyridoxine hydrochloride is effective and well tolerated in treating nausea and vomiting of pregnancy."5.14Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Mattison, DR; Miodovnik, M; Umans, JG, 2010)
" We used as a motivating example the possible teratogenic risks of antiemetic agents in pregnancy since a large observational study recently showed that first-trimester exposure to doxylamine-pyridoxine was associated with significantly increased risk of congenital malformations as a whole, as well as central nervous system defects, and previous observational studies did not show such associations."5.12Misleading meta-analyses of observational studies may generate unjustified alarms: The case of medications for nausea and vomiting in pregnancy. ( Biffi, A; Cetin, I; Corrao, G; Filippelli, A; Locatelli, A; Rea, F, 2021)
"A double-blind comparison was undertaken between Debendox with 10mg of extra pyridoxine and placebo with 10mg of pyridoxine, in 56 women suffering from nausea and/or vomiting during the first 10 weeks of pregnancy."5.04Treatment of pregnancy sickness. ( Wheatley, D, 1977)
""Bendectin" (Doxylamine/Dicyclomine/Pyridoxine) was widely used for the treatment of nausea and vomiting of pregnancy until 1983, when production was discontinued in the face of lawsuits alleging that the drug caused congenital malformations."4.79Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. ( Kutcher, JS; Lamm, SH; Linn, S; McKeigue, PM, 1994)
"Using the Quebec Pregnancy Cohort (1998-2015), first-trimester doxylamine-pyridoxine, metoclopramide, and ondansetron exposures were assessed for their association with MCM."3.91New evidence for concern over the risk of birth defects from medications for nausea and vomitting of pregnancy. ( Bérard, A; Bernatsky, S; Gorgui, J; Sheehy, O; Soares de Moura, C; Zhao, JP, 2019)
"Doxylamine-pyridoxine is the first-line agent for the treatment of nausea and vomiting of pregnancy (NVP) according to Canadian guidelines, and this combination is commonly prescribed to pregnant women."3.80Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy? ( Chin, J; Persaud, N; Walker, M, 2014)
"The US FDA approval in April 2013 of Diclegis®, the doxylamine-pyridoxine combination for morning sickness, is a major milestone, particularly since it is indicated for use in pregnancy and the FDA has labeled it a pregnancy category A drug the strongest evidence of fetal safety."3.79The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women. ( Koren, G, 2013)
"Diclectin (pyridoxine 10 mg and doxylamine 10 mg) has traditionally been used to treat nausea and vomiting of pregnancy (NVP); however, this drug is unavailable in many countries."3.79Evaluation of the efficacy and safety of bi-daily combination therapy with pyridoxine and doxylamine for nausea and vomiting of pregnancy. ( Ashkenazi-Hoffnung, L; Klinger, G; Merlob, P; Stahl, B, 2013)
"Diclectin, composed of 10 mg doxylamine succinate (DOX) and 10 mg pyridoxine hydrochloride, is the drug combination of choice for the management of nausea and vomiting during pregnancy in Canada."3.77Systemic bioavailability and pharmacokinetics of the doxylamine-pyridoxine delayed-release combination (Diclectin). ( Garcia-Bournissen, F; Gill, SK; Koren, G, 2011)
" Although no definitive causative factor has been identified in previously reported cases, the affection in our case is possibly related to Debendox (Bendectin) and nitrofurantoin taken in early pregnancy for nausea and renal tract infection, respectively."3.69Congenital symmetrical weakness of the upper limbs resembling brachial plexus palsy: a possible sequel of drug toxicity in first trimester of pregnancy? ( Dubowitz, V; Muntoni, F; Philpot, J; Skellett, S, 1995)
"The antinausea drug combination, doxylamine/dicyclomine/pyridoxine (Debendox or Bendectin [US] ), has been withdrawn from the market because of litigation based upon charges that it causes congenital limb defects."3.67The innocent bystander. Doxylamine/dicyclomine/pyridoxine and congenital limb defects. ( Elliott, J; Forrest, J; Kricker, A; McCredie, J, 1984)
"Bendectin, composed of doxylamine succinate and pyridoxine HCl (1:1), is an antinauseant previously prescribed for nausea and vomiting during pregnancy."3.67Developmental toxicity evaluation of Bendectin in CD rats. ( Kimmel, CA; Marr, MC; Price, CJ; Tyl, RW, 1988)
" The pregnancy was complicated by chronic maternal schizophrenia, severe toxaemia and maternal use of fluphenazine enanthate, dicyclomine hydrochloride, doxylamine succinate, pyridoxine hydrochloride and other drugs."3.66Multiple congenital abnormalities in a newborn boy associated with maternal use of fluphenazine enanthate and other drugs during pregnancy. ( Bury, RG; Donaldson, GL, 1982)
"In a prospective cohort study of 20, 282 gravidas and their offspring, congenital malformation rates were similar in the children of over 1,000 women exposed and those not exposed to two components of Bendectin (doxylamine succinate and dicyclomine hydrochloride) during the first four lunar months of pregnancy."3.65Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score. ( Heinonen, OP; Kaufman, DW; Monson, RR; Shapiro, S; Siskind, V; Slone, D, 1977)
"Incidence rates of colorectal cancer (CRC) are increasing among adults born in and after the 1960s, implicating pregnancy-related exposures introduced at that time as risk factors."3.01In utero exposure to antiemetic and risk of adult-onset colorectal cancer. ( Cirillo, PM; Cohn, BA; Krigbaum, NY; Murphy, CC; Singal, AG, 2023)
"A four day study drug dosing trial with Diclegis® is sufficient to document efficacy, as the results are similar to those achieved after 14 study drug dosing days."2.82Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. ( Caritis, SN; Clark, S; Hankins, GD; Koren, G; Matok, I; Mattison, DR; Miodovnik, M; Umans, JG, 2016)
" Pharmacokinetic parameters were calculated for each study period using standard, non-compartmental methods, and differences were assessed using ANOVA."2.78Sex differences in the pharmacokinetics and bioequivalence of the delayed-release combination of doxylamine succinate-pyridoxine hydrochloride; implications for pharmacotherapy in pregnancy. ( Gill, SK; Koren, G; Macleod, S; Vranderick, M, 2013)
"81 and a dose-response relationship was noted (P = 0."2.66Maternal drug use and risk of childhood nonlymphoblastic leukemia among offspring. An epidemiologic investigation implicating marijuana (a report from the Childrens Cancer Study Group). ( Arthur, DC; Benjamin, D; Buckley, JD; Daigle, AE; Hammond, GD; Robison, LL; Wells, R, 1989)
"Nausea and vomiting are common in early pregnancy."2.50The pharmacologic management of nausea and vomiting of pregnancy. ( Briggs, GG; Niebyl, JR, 2014)
" Pyridoxine is considered safe for use during pregnancy, but its efficacy in treating nausea and vomiting has not been determined."2.37Safety and efficacy of antiemetics used to treat nausea and vomiting in pregnancy. ( Leathem, AM, 1986)
"Two hundred cases of verified brain tumors occurring in patients under 15 years of age were studied in relation to possible etiologic, genetic, and environmental risk factors."1.28Potential risk factors for brain tumors in children. An analysis of 200 cases. ( Giuffrè, R; Liccardo, G; Pastore, FS; Spallone, A; Vagnozzi, R, 1990)
" Two pharmacokinetic experiments were performed in each animal, one on the first day of treatment and one on the last day of treatment."1.28Pharmacokinetics of doxylamine given as Bendectin in the pregnant monkey and baboon. ( Denton, R; Hendrickx, AG; Holder, CL; Prahalada, S; Rowland, JM; Slikker, W; Young, JF, 1989)
" There was no correlation between dosage and the number of prenatal deaths."1.27Evaluation of bendectin embryotoxicity in nonhuman primates: II. Double-blind study in term cynomolgus monkeys. ( Booher, S; Cukierski, M; Hendrickx, AG; Janos, G; Nyland, T; Prahalada, S, 1985)
" No dose-response relationship was evident."1.27Inter-Regional Epidemiological Study of Childhood Cancer (IRESCC): childhood cancer and the consumption of debendox and related drugs in pregnancy. ( Birch, JM; Cartwright, RA; Hartley, AL; Hopton, PA; Johnston, HE; Mann, JR; McKinney, PA; Stiller, CA; Waterhouse, JA, 1985)

Research

Studies (154)

TimeframeStudies, this research(%)All Research%
pre-199095 (61.69)18.7374
1990's18 (11.69)18.2507
2000's10 (6.49)29.6817
2010's28 (18.18)24.3611
2020's3 (1.95)2.80

Authors

AuthorsStudies
Murphy, CC1
Cirillo, PM1
Krigbaum, NY1
Singal, AG1
Cohn, BA1
Fejzo, MS1
Trovik, J1
Grooten, IJ1
Sridharan, K1
Roseboom, TJ1
Vikanes, Å1
Painter, RC1
Mullin, PM1
MacDuffie, KE1
Kleinhans, NM1
Stout, K1
Wilfond, BS1
Biffi, A1
Rea, F1
Locatelli, A1
Cetin, I1
Filippelli, A1
Corrao, G1
Bérard, A1
Sheehy, O1
Gorgui, J1
Zhao, JP1
Soares de Moura, C1
Bernatsky, S1
Matok, I6
Clark, S8
Caritis, S4
Miodovnik, M8
Umans, J2
Hankins, G3
Koren, G21
Ashkenazi-Hoffnung, L1
Merlob, P1
Stahl, B1
Klinger, G1
Feghali, MN1
Mattison, DR6
Nordeng, H1
Vranderick, M1
Gill, SK2
Macleod, S1
Howland, RH1
Niebyl, JR2
Briggs, GG1
Hansen, KA1
Madjunkova, S1
Maltepe, C5
Slaughter, SR1
Hearns-Stokes, R1
van der Vlugt, T1
Joffe, HV1
Persaud, N3
Chin, J1
Walker, M1
Umans, JG6
Pope, E1
Hankins, GD5
Caritis, SN4
Zhang, R1
Dyer, O1
Nulman, I1
Rovet, J1
Barrera, M1
Knittel-Keren, D1
Feldman, BM1
Garcia-Bournissen, F2
Healy, D1
Costantine, MM1
Chiossi, G1
Louik, C2
Mitchell, AA4
Brent, R2
Kutcher, JS2
Engle, A1
Firth, J1
Lamm, SH2
CAMPBELL, CG1
McDONALD, RH1
FACHNIE, HA1
STEVENSON, CS1
NULSEN, RO1
TOWNE, JE1
GEIGER, CJ1
FAHRENBACH, DM1
HEALEY, FJ1
Staroselsky, A1
Clarke, M1
Clayton, DG1
Hall, JB1
Bracken, MB2
Berg, A1
Shapiro, S4
Hughes, DT1
Cavanagh, N1
Smithells, RW2
Sheppard, S2
Holmes, LB1
Patterson, SP1
Hill, LM1
Kleinberg, F1
Cordero, JF2
Oakley, GP2
Aselton, P2
Jick, H4
Chentow, SJ1
Perera, DR1
Hunter, JR2
Rothman, KJ2
Grodofsky, MP1
Wilmott, RW1
Maling, TJ1
Leeder, JS1
Spielberg, SP1
MacLeod, SM1
Hays, DP1
Brushwood, DB2
Schwingl, PJ1
Rosenberg, L2
Aselton, PJ1
Williams, DA1
Weiss, T1
Wade, E1
Dignan, P1
McCredie, J1
Kricker, A1
Elliott, J1
Forrest, J1
Davis, JM1
Correy, JF4
Newman, NM4
Smith, R1
Fleming, DM1
Knox, JD1
Crombie, DL1
Michaelis, J1
Michaelis, H1
Glück, E1
Koller, S1
Brent, RR1
Brown, A1
Leal, J1
Huff, PS1
Smith, RJ1
Kolata, G2
Morelock, S1
Hingson, R1
Kayne, H1
Dooling, E1
Zuckerman, B1
Day, N1
Alpert, JJ1
Flowerdew, G1
David, TJ1
Donaldson, GL1
Bury, RG1
Eskenazi, B1
Greenberg, F1
James, LM1
Slone, D2
Gibson, GT1
Colley, DP1
McMichael, AJ1
Hartshorne, JM1
Kolata, GB1
Harron, DW1
Griffiths, K1
Shanks, RG1
Korcok, M1
Paigen, B1
Pearson, RD1
Philpot, J1
Muntoni, F1
Skellett, S1
Dubowitz, V1
McKeigue, PM1
Linn, S1
Bertin, JE1
Henifin, MS1
McBride, WG2
Green, MD1
Marshall, E1
Brent, RL2
Pastuszak, A1
Ito, S1
Einarson, A1
Bailey, B1
Mazzotta, P1
Navioz, Y1
Magee, LA1
Strong, TH1
Wheatley, D1
Check, WA1
Harris, R1
Milkovich, L1
van den Berg, BJ1
Patterson, DC1
Heinonen, OP1
Siskind, V1
Kaufman, DW1
Monson, RR1
Brannigan, VM1
Bier, VM1
Berg, C1
Collins, JA1
Burrows, EA1
Burrows, RF1
Curran, JT1
Saunders, EJ1
Saunders, JA1
Giuffrè, R1
Liccardo, G1
Pastore, FS1
Spallone, A1
Vagnozzi, R1
Munro, CD1
Newman, SA1
Skolnick, A1
Rowland, JM1
Slikker, W1
Holder, CL1
Denton, R1
Prahalada, S3
Young, JF1
Hendrickx, AG3
Robison, LL1
Buckley, JD1
Daigle, AE1
Wells, R1
Benjamin, D1
Arthur, DC1
Hammond, GD1
Shiono, PH1
Klebanoff, MA1
Leathem, AM1
Kiley, VA1
Lazerson, J1
Jick, SS1
Garrison, JM1
Jedd, MB1
Melton, LJ1
Griffin, MR1
Kaufman, B1
Hoffman, AD1
Broughton, D1
O'Brien, PC1
Tyl, RW1
Price, CJ1
Marr, MC1
Kimmel, CA1
Goldberg, JD1
Golbus, MS1
Elbourne, D2
Mutch, L2
Walters, WA1
Melnick, M1
Porter, JB1
Hunter-Mitchell, J1
Walker, AM1
Sheffield, LJ1
Batagol, R1
Orme, ML1
Milunsky, A1
Stergachis, A1
Zierler, S1
Danks, DM1
Dauncey, M1
Campbell, H1
Samphier, M1
Cukierski, M2
Janos, G2
Rowland, J1
Booher, S1
Nyland, T1
McKinney, PA1
Cartwright, RA1
Stiller, CA1
Hopton, PA1
Mann, JR1
Birch, JM1
Hartley, AL1
Waterhouse, JA1
Johnston, HE1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022[NCT06055192]200 participants (Anticipated)Observational2023-09-30Not yet recruiting
A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy[NCT00614445]Phase 3280 participants (Actual)Interventional2008-01-31Completed
A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy[NCT00409825]Phase 261 participants (Actual)Interventional2006-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).

The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rated from 3 (no symptoms) to 15 (most severe). (NCT00614445)
Timeframe: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)

InterventionPUQE Score (Mean)
Diclectin®-4.8
Placebo-3.9

Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.

"Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy.~We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days." (NCT00409825)
Timeframe: Second and third trimesters of pregnancy

Interventionng/ML/day (Mean)
AUC -1AUC - 2
Part 1115136

Reviews

18 reviews available for dicyclomine and Pregnancy

ArticleYear
In utero exposure to antiemetic and risk of adult-onset colorectal cancer.
    JNCI cancer spectrum, 2023, 03-01, Volume: 7, Issue:2

    Topics: Adult; Antiemetics; Colorectal Neoplasms; Dicyclomine; Female; Humans; Mothers; Pregnancy; Prenatal

2023
Nausea and vomiting of pregnancy and hyperemesis gravidarum.
    Nature reviews. Disease primers, 2019, 09-12, Volume: 5, Issue:1

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Growth Differentiation Factor 15; H

2019
Misleading meta-analyses of observational studies may generate unjustified alarms: The case of medications for nausea and vomiting in pregnancy.
    Pharmacological research, 2021, Volume: 163

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

2021
Doxylamine/pyridoxine for nausea and vomiting in pregnancy.
    Drug and therapeutics bulletin, 2019, Volume: 57, Issue:3

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Practice Guidelines

2019
The pharmacologic management of nausea and vomiting of pregnancy.
    The Journal of family practice, 2014, Volume: 63, Issue:2 Suppl

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Histamine H1 Antagonists; Humans; N

2014
The delayed-release combination of doxylamine and pyridoxine (Diclegis®/Diclectin ®) for the treatment of nausea and vomiting of pregnancy.
    Paediatric drugs, 2014, Volume: 16, Issue:3

    Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

2014
Clinical practice. Nausea and vomiting in pregnancy.
    The New England journal of medicine, 2010, Oct-14, Volume: 363, Issue:16

    Topics: Adult; Chorionic Gonadotropin; Complementary Therapies; Diagnosis, Differential; Dicyclomine; Doxyla

2010
Teratogen update: bendectin.
    Teratology, 1983, Volume: 27, Issue:2

    Topics: Abnormalities, Drug-Induced; Animals; Dicyclomine; Doxylamine; Drug Combinations; Drug Utilization;

1983
Effects of drugs and chemicals on the fetus and newborn (1).
    Mayo Clinic proceedings, 1984, Volume: 59, Issue:10

    Topics: Abnormalities, Drug-Induced; Animals; Antiemetics; Behavior; Caffeine; Dicyclomine; Doxylamine; Drug

1984
Drug exposure during pregnancy: some epidemiologic considerations.
    Clinical obstetrics and gynecology, 1983, Volume: 26, Issue:2

    Topics: Abnormalities, Drug-Induced; Benzodiazepines; Caffeine; Dicyclomine; Doxylamine; Drug Combinations;

1983
Safety of drug therapy for nausea and vomiting of pregnancy.
    The Journal of family practice, 1980, Volume: 11, Issue:6

    Topics: Abnormalities, Drug-Induced; Antiemetics; Child; Dicyclomine; Doxylamine; Drug Combinations; Female;

1980
Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies.
    Teratology, 1994, Volume: 50, Issue:1

    Topics: Abnormalities, Drug-Induced; Antiemetics; Case-Control Studies; Cohort Studies; Dicyclomine; Doxylam

1994
Drugs in pregnancy.
    The New England journal of medicine, 1998, Apr-16, Volume: 338, Issue:16

    Topics: Abnormalities, Drug-Induced; Animals; Counseling; Dicyclomine; Doxylamine; Drug Combinations; Drug E

1998
Alternative therapies of morning sickness.
    Clinical obstetrics and gynecology, 2001, Volume: 44, Issue:4

    Topics: Acupressure; Antiemetics; Complementary Therapies; Dicyclomine; Doxylamine; Drug Combinations; Femal

2001
Medical, social, and legal implications of treating nausea and vomiting of pregnancy.
    American journal of obstetrics and gynecology, 2002, Volume: 186, Issue:5 Suppl Un

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

2002
Drug therapy in pregnancy: the lessons of diethylstilbestrol, thalidomide, and bendectin.
    Health care for women international, 1990, Volume: 11, Issue:4

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Diethylstilbestrol; Doxylamine; Drug Combinat

1990
Safety and efficacy of antiemetics used to treat nausea and vomiting in pregnancy.
    Clinical pharmacy, 1986, Volume: 5, Issue:8

    Topics: Antiemetics; Antipsychotic Agents; Dicyclomine; Diphenhydramine; Doxylamine; Drug Combinations; Fema

1986
The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?
    The Medical journal of Australia, 1985, Aug-19, Volume: 143, Issue:4

    Topics: Abnormalities, Drug-Induced; Animals; Antiemetics; Australia; Clinical Trials as Topic; Cyclohexanec

1985

Trials

17 trials available for dicyclomine and Pregnancy

ArticleYear
Comparing the pharmacokinetics of doxylamine/pyridoxine delayed-release combination in nonpregnant women of reproductive age and women in the first trimester of pregnancy.
    Journal of clinical pharmacology, 2013, Volume: 53, Issue:3

    Topics: Adolescent; Adult; Antiemetics; Delayed-Action Preparations; Dicyclomine; Double-Blind Method; Doxyl

2013
Sex differences in the pharmacokinetics and bioequivalence of the delayed-release combination of doxylamine succinate-pyridoxine hydrochloride; implications for pharmacotherapy in pregnancy.
    Journal of clinical pharmacology, 2013, Volume: 53, Issue:12

    Topics: Adult; Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female;

2013
Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs.
    Journal of clinical pharmacology, 2014, Volume: 54, Issue:12

    Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Double-Blind Method; Doxylamine; Drug Combina

2014
Comparing pyridoxine and doxylamine succinate-pyridoxine HCl for nausea and vomiting of pregnancy: A matched, controlled cohort study.
    Journal of clinical pharmacology, 2015, Volume: 55, Issue:7

    Topics: Adult; Antiemetics; Cohort Studies; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Morn

2015
Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial.
    BMC pregnancy and childbirth, 2015, Mar-18, Volume: 15

    Topics: Adult; Antiemetics; Delayed-Action Preparations; Dicyclomine; Double-Blind Method; Doxylamine; Drug

2015
Effectiveness of doxylamine-pyridoxine for morning sickness.
    American journal of obstetrics and gynecology, 2016, Volume: 214, Issue:5

    Topics: Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Morning Sic

2016
Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy.
    BMC pregnancy and childbirth, 2016, 11-24, Volume: 16, Issue:1

    Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

2016
8-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information.
    PloS one, 2017, Volume: 12, Issue:1

    Topics: Cooperative Behavior; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Physicians

2017
Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial.
    American journal of obstetrics and gynecology, 2010, Volume: 203, Issue:6

    Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth

2010
Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial.
    American journal of obstetrics and gynecology, 2010, Volume: 203, Issue:6

    Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth

2010
Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial.
    American journal of obstetrics and gynecology, 2010, Volume: 203, Issue:6

    Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth

2010
Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial.
    American journal of obstetrics and gynecology, 2010, Volume: 203, Issue:6

    Topics: Adult; Delayed-Action Preparations; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Meth

2010
Determinants of adherence to delayed-release doxylamine and pyridoxine in patients with nausea and vomiting of pregnancy.
    Therapeutic drug monitoring, 2012, Volume: 34, Issue:5

    Topics: Adult; Antiemetics; Cohort Studies; Delayed-Action Preparations; Dicyclomine; Double-Blind Method; D

2012
Pre-emptive therapy for severe nausea and vomiting of pregnancy and hyperemesis gravidarum.
    Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 2004, Volume: 24, Issue:5

    Topics: Adult; Antiemetics; Dicyclomine; Doxylamine; Drug Administration Schedule; Drug Combinations; Female

2004
Studies support Bendectin safety claim.
    Science (New York, N.Y.), 1981, Jun-26, Volume: 212, Issue:4502

    Topics: Antiemetics; Clinical Trials as Topic; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; I

1981
FDA to reexamine bendectin data.
    Science (New York, N.Y.), 1982, Jul-23, Volume: 217, Issue:4557

    Topics: Abnormalities, Drug-Induced; Animals; Clinical Trials as Topic; Dicyclomine; Doxylamine; Drug Combin

1982
Treatment of pregnancy sickness.
    British journal of obstetrics and gynaecology, 1977, Volume: 84, Issue:6

    Topics: Clinical Trials as Topic; Cyclohexanecarboxylic Acids; Dicyclomine; Double-Blind Method; Doxylamine;

1977
An evaluation of the teratogenicity of certain antinauseant drugs.
    American journal of obstetrics and gynecology, 1976, May-15, Volume: 125, Issue:2

    Topics: Abnormalities, Drug-Induced; Antiemetics; Clinical Trials as Topic; Cyclizine; Dicyclomine; Doxylami

1976
Maternal drug use and risk of childhood nonlymphoblastic leukemia among offspring. An epidemiologic investigation implicating marijuana (a report from the Childrens Cancer Study Group).
    Cancer, 1989, May-15, Volume: 63, Issue:10

    Topics: Adolescent; Age Factors; Antiemetics; Child; Child, Preschool; Dicyclomine; Doxylamine; Drug Combina

1989
The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?
    The Medical journal of Australia, 1985, Aug-19, Volume: 143, Issue:4

    Topics: Abnormalities, Drug-Induced; Animals; Antiemetics; Australia; Clinical Trials as Topic; Cyclohexanec

1985

Other Studies

120 other studies available for dicyclomine and Pregnancy

ArticleYear
Protection Versus Progress: The Challenge of Research on Cannabis Use During Pregnancy.
    Pediatrics, 2020, Volume: 146, Issue:Suppl 1

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Ethics, Research; Female; Hu

2020
New evidence for concern over the risk of birth defects from medications for nausea and vomitting of pregnancy.
    Journal of clinical epidemiology, 2019, Volume: 116

    Topics: Abnormalities, Drug-Induced; Adult; Antiemetics; Cohort Studies; Dicyclomine; Doxylamine; Drug Combi

2019
Evaluation of the efficacy and safety of bi-daily combination therapy with pyridoxine and doxylamine for nausea and vomiting of pregnancy.
    The Israel Medical Association journal : IMAJ, 2013, Volume: 15, Issue:1

    Topics: Administration, Oral; Adult; Antiemetics; Case-Control Studies; Dicyclomine; Dose-Response Relations

2013
The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women.
    Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique, 2013, Volume: 20, Issue:2

    Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations;

2013
Diclegis for nausea and vomiting of pregnancy.
    The Medical letter on drugs and therapeutics, 2013, Aug-05, Volume: 55, Issue:1422

    Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

2013
Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial.
    Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 2013, Volume: 33, Issue:6

    Topics: Adult; Dicyclomine; Double-Blind Method; Doxylamine; Drug Combinations; Female; Histamine H1 Antagon

2013
Concern for truth: driving defensively when confronting a zombie epidemic.
    Journal of psychosocial nursing and mental health services, 2013, Volume: 51, Issue:11

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Histor

2013
Diclegis: return of a medication.
    South Dakota medicine : the journal of the South Dakota State Medical Association, 2013, Volume: 66, Issue:12

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Female; Humans; Morning Sick

2013
FDA approval of doxylamine-pyridoxine therapy for use in pregnancy.
    The New England journal of medicine, 2014, Mar-20, Volume: 370, Issue:12

    Topics: Antiemetics; Congenital Abnormalities; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Fe

2014
Should doxylamine-pyridoxine be used for nausea and vomiting of pregnancy?
    Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC, 2014, Volume: 36, Issue:4

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

2014
Treating morning sickness in the United States--changes in prescribing are needed.
    American journal of obstetrics and gynecology, 2014, Volume: 211, Issue:6

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Female; Heart Defects, Conge

2014
Flawed invisible trial underpins US morning sickness drug, researchers say.
    BMJ (Clinical research ed.), 2017, Jan-09, Volume: 356

    Topics: Antiemetics; Clinical Trials as Topic; Dicyclomine; Doxylamine; Drug Approval; Drug Combinations; Fe

2017
Long-term neurodevelopment of children exposed to maternal nausea and vomiting of pregnancy and diclectin.
    The Journal of pediatrics, 2009, Volume: 155, Issue:1

    Topics: Adult; Antiemetics; Child; Child Development; Child, Preschool; Cohort Studies; Dicyclomine; Doxylam

2009
Systemic bioavailability and pharmacokinetics of the doxylamine-pyridoxine delayed-release combination (Diclectin).
    Therapeutic drug monitoring, 2011, Volume: 33, Issue:1

    Topics: Adult; Antiemetics; Biological Availability; Canada; Delayed-Action Preparations; Dicyclomine; Doxyl

2011
Epidemiological evidence in forensic pharmacovigilance.
    The International journal of risk & safety in medicine, 2012, Volume: 24, Issue:1

    Topics: Abnormalities, Drug-Induced; Antiemetics; Breast Implantation; Causality; Connective Tissue Diseases

2012
Prenatal prescription of macrolide antibiotics and infantile hypertrophic pyloric stenosis.
    Obstetrics and gynecology, 2003, Volume: 101, Issue:4

    Topics: Anti-Bacterial Agents; Confounding Factors, Epidemiologic; Dicyclomine; Doxylamine; Drug Combination

2003
Bendectin and birth defects: hopefully, the final chapter.
    Birth defects research. Part A, Clinical and molecular teratology, 2003, Volume: 67, Issue:2

    Topics: Abnormalities, Drug-Induced; Adult; Adverse Drug Reaction Reporting Systems; Animals; Antiemetics; C

2003
Bendectin and birth defects. II: Ecological analyses.
    Birth defects research. Part A, Clinical and molecular teratology, 2003, Volume: 67, Issue:2

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Adult; Adverse Drug Reaction Reporting Systems

2003
Absence of effect of bentyl hydrochloride upon human uterus during parturition.
    Journal of applied physiology, 1955, Volume: 7, Issue:4

    Topics: Delivery, Obstetric; Dicyclomine; Female; Humans; Labor, Obstetric; Muscle Relaxants, Central; Partu

1955
Bendectin in the treatment of nausea of pregnancy.
    The Ohio State medical journal, 1957, Volume: 53, Issue:6

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Histamine H1 Antagonists; Muscle Relaxants, Central; Nau

1957
Nausea and vomiting of pregnancy: treatment with bendectin.
    International record of medicine and general practice clinics, 1958, Volume: 171, Issue:9

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Histamine H1 Antagonists; Muscle Relaxants, Central; Nau

1958
Bendectin in the treatment of nausea and vomiting in pregnancy.
    Obstetrics and gynecology, 1959, Volume: 14

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Histamine H1 Antagonists; Muscle Relaxants, Central; Nau

1959
American Gastroenterological Association institute medical position statement on the use of gastrointestinal medication in pregnancy.
    Gastroenterology, 2007, Volume: 132, Issue:2

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Gastrointestinal Agents; Gastrointe

2007
Preventing recurrence of severe morning sickness.
    Canadian family physician Medecin de famille canadien, 2006, Volume: 52, Issue:12

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Morning Sickness; Ondansetr

2006
Safety of Debendox.
    Lancet (London, England), 1981, Mar-21, Volume: 1, Issue:8221

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Fetal Death; Humans

1981
Debendox in pregnancy.
    Lancet (London, England), 1981, Jul-18, Volume: 2, Issue:8238

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Fetus; Humans; Infa

1981
Bendectin (Debendox) and congenital diaphragmatic hernia.
    Lancet (London, England), 1983, Mar-12, Volume: 1, Issue:8324

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Fetus; Hernia, Diaphragmatic; Herni

1983
Bendectin (debendox) and congenital diaphragmatic hernia.
    Lancet (London, England), 1983, Apr-23, Volume: 1, Issue:8330

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Hernias, Diaphragmatic, Congenital;

1983
Chromosomal studies on children with phocomelia, exposed to debendox during early pregnancy.
    Lancet (London, England), 1983, Aug-13, Volume: 2, Issue:8346

    Topics: Chromosome Inversion; Dicyclomine; Doxylamine; Drug Combinations; Ectromelia; Female; Humans; Infant

1983
Teratogenicity of debendox and pyrimethamine.
    Lancet (London, England), 1983, Sep-10, Volume: 2, Issue:8350

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Pregnancy;

1983
Debendox is not thalidomide.
    Lancet (London, England), 1984, Jul-28, Volume: 2, Issue:8396

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

1984
Our bundle of responsibility. Presidential address.
    American journal of obstetrics and gynecology, 1984, Jun-01, Volume: 149, Issue:3

    Topics: Abnormalities, Drug-Induced; Costs and Cost Analysis; Delivery of Health Care; Dicyclomine; Doxylami

1984
Pyloric stenosis and maternal Bendectin exposure.
    American journal of epidemiology, 1984, Volume: 120, Issue:2

    Topics: Adult; Dicyclomine; Doxylamine; Drug Combinations; Drug Prescriptions; Female; Follow-Up Studies; Hu

1984
Possible association of use of bendectin during early pregnancy and congenital lung hypoplasia.
    The New England journal of medicine, 1984, Sep-13, Volume: 311, Issue:11

    Topics: Abnormalities, Drug-Induced; Adult; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female;

1984
Debendox and pregnancy.
    The Medical journal of Australia, 1984, Oct-13, Volume: 141, Issue:8

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Pre

1984
Debendox: a statement from the New Zealand Adverse Drug Reactions Committee.
    The New Zealand medical journal, 1984, Mar-28, Volume: 97, Issue:752

    Topics: Antiemetics; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

1984
No more bendectin.
    American family physician, 1983, Volume: 28, Issue:3

    Topics: Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug Combinations; Drug Industry; Female; Huma

1983
Bendectin and pyloric stenosis.
    FDA drug bulletin, 1983, Volume: 13, Issue:2

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Infant, Newborn; Pregnancy;

1983
Bendectin: the wrong way to regulate drug availability.
    Canadian Medical Association journal, 1983, Nov-15, Volume: 129, Issue:10

    Topics: Abnormalities, Drug-Induced; Canada; Dicyclomine; Doxylamine; Drug Combinations; Drug Industry; Fema

1983
Nausea and vomiting of pregnancy.
    American family physician, 1983, Volume: 28, Issue:4

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Pregnancy; Pregnanc

1983
Bendectin: a case of mourning sickness.
    Drug intelligence & clinical pharmacy, 1983, Volume: 17, Issue:11

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Pregnancy; Pregnanc

1983
Two legal issues: expert witnesses and Bendectin case.
    Drug intelligence & clinical pharmacy, 1983, Volume: 17, Issue:11

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Expert Testimony; Female; Humans; Jurisprudence; Pregnan

1983
Birth defects in relation to Bendectin use in pregnancy. II. Pyloric stenosis.
    American journal of obstetrics and gynecology, 1983, Dec-01, Volume: 147, Issue:7

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Hyperemesis

1983
Bendectin and pyloric stenosis in infants.
    American journal of obstetrics and gynecology, 1983, Dec-15, Volume: 147, Issue:8

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Infant, Newborn; Maternal-Fetal Exchange

1983
Additional follow-up of congenital limb disorders in relation to Bendectin use.
    JAMA, 1983, Jul-01, Volume: 250, Issue:1

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Follow

1983
Prune perineum syndrome: report of a second case.
    Teratology, 1983, Volume: 28, Issue:1

    Topics: Abnormalities, Multiple; Acetaminophen; Adult; Codeine; Dextropropoxyphene; Dicyclomine; Female; Hum

1983
The innocent bystander. Doxylamine/dicyclomine/pyridoxine and congenital limb defects.
    The Medical journal of Australia, 1984, Apr-28, Volume: 140, Issue:9

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Dose-Response Relationship, Drug; Doxylamine;

1984
Good-bye, Bendectin, old friend.
    Postgraduate medicine, 1984, May-15, Volume: 75, Issue:7

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Drug Industry; Female; Huma

1984
Debendox withdrawn.
    The Medical journal of Australia, 1984, Jun-23, Volume: 140, Issue:13

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Infant, New

1984
Product liability all dressed up American style.
    British medical journal (Clinical research ed.), 1981, May-09, Volume: 282, Issue:6275

    Topics: Antiemetics; Dicyclomine; Diethylstilbestrol; Doxylamine; Drug Combinations; Drug Industry; Drug Lab

1981
Debendox in early pregnancy and fetal malformation.
    British medical journal (Clinical research ed.), 1981, Jul-11, Volume: 283, Issue:6284

    Topics: Abnormalities, Drug-Induced; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug Combinations

1981
Prospective study of suspected associations between certain drugs administered during early pregnancy and congenital malformations.
    Teratology, 1983, Volume: 27, Issue:1

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Estradiol; Fem

1983
Congenital malformations.
    The New England journal of medicine, 1983, Aug-04, Volume: 309, Issue:5

    Topics: Abnormalities, Drug-Induced; Congenital Abnormalities; Dicyclomine; Doxylamine; Drug Combinations; F

1983
The Bendectin Saga: another American tragedy (Brent, '80).
    Teratology, 1983, Volume: 27, Issue:2

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Jurispruden

1983
Debendox in the dock.
    Nursing mirror, 1980, Feb-21, Volume: 150, Issue:8

    Topics: Abnormalities, Drug-Induced; Antiemetics; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug

1980
Bendectin use during pregnancy.
    The American journal of nursing, 1982, Volume: 82, Issue:11

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Pregnancy;

1982
Bendectin and fetal development. A study of Boston City Hospital.
    American journal of obstetrics and gynecology, 1982, Jan-15, Volume: 142, Issue:2

    Topics: Abnormalities, Drug-Induced; Antiemetics; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug

1982
Bendectin PPI available.
    FDA drug bulletin, 1982, Volume: 12, Issue:1

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Drug Labeling; Female; Humans; Patient Educ

1982
Debendox does not cause the Poland anomaly.
    Archives of disease in childhood, 1982, Volume: 57, Issue:6

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Antiemetics; Dicyclomine; Doxylamine; Drug Com

1982
Multiple congenital abnormalities in a newborn boy associated with maternal use of fluphenazine enanthate and other drugs during pregnancy.
    Acta paediatrica Scandinavica, 1982, Volume: 71, Issue:2

    Topics: Abnormalities, Drug-Induced; Cleft Lip; Cleft Palate; Dicyclomine; Doxylamine; Female; Fluphenazine;

1982
Bendectin (Debendox) as a risk factor for pyloric stenosis.
    American journal of obstetrics and gynecology, 1982, Dec-15, Volume: 144, Issue:8

    Topics: Abnormalities, Drug-Induced; Adult; Dicyclomine; Doxylamine; Drug Combinations; Female; Heart Defect

1982
The law and Bendectin.
    American family physician, 1981, Volume: 23, Issue:4

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Jurispruden

1981
Indications for bendectin narrowed.
    FDA drug bulletin, 1981, Volume: 11, Issue:1

    Topics: Antiemetics; Carcinogens; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Pregnancy; Pre

1981
Is Bendectin a teratogen?
    JAMA, 1981, Jun-12, Volume: 245, Issue:22

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Drug Evaluatio

1981
Birth defects related to bendectin use in pregnancy. I. Oral clefts and cardiac defects.
    JAMA, 1981, Jun-12, Volume: 245, Issue:22

    Topics: Antiemetics; Cleft Lip; Cleft Palate; Dicyclomine; Doxylamine; Drug Combinations; Drug Evaluation; F

1981
Congenital anomalies in relation to the use of doxylamine/dicyclomine and other antenatal factors: an ongoing prospective study.
    The Medical journal of Australia, 1981, Apr-18, Volume: 1, Issue:8

    Topics: Abnormalities, Drug-Induced; Adult; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug Combi

1981
Debendox and limb reduction deformities.
    The Medical journal of Australia, 1981, Apr-18, Volume: 1, Issue:8

    Topics: Abnormalities, Drug-Induced; Australia; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug C

1981
Debendox and the media.
    British medical journal, 1980, Feb-16, Volume: 280, Issue:6212

    Topics: Abnormalities, Drug-Induced; Cyclohexanecarboxylic Acids; Dicyclomine; Female; Humans; Infant, Newbo

1980
Debendox in pregnancy.
    The Medical journal of Australia, 1980, Mar-08, Volume: 1, Issue:5

    Topics: Abnormalities, Drug-Induced; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug Combinations

1980
How safe is Bendectin?
    Science (New York, N.Y.), 1980, Oct-31, Volume: 210, Issue:4469

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Drug Evaluation; Female; Hu

1980
Debendox and congenital malformations in Northern Ireland.
    British medical journal, 1980, Nov-22, Volume: 281, Issue:6252

    Topics: Abnormalities, Drug-Induced; Antiemetics; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug

1980
The Bendectin debate.
    Canadian Medical Association journal, 1980, Nov-08, Volume: 123, Issue:9

    Topics: Abnormalities, Drug-Induced; Animals; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Femal

1980
Public health issues: bendectin, love canal.
    Science (New York, N.Y.), 1981, Jan-02, Volume: 211, Issue:4477

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; New York; Pregnancy; Pyridines; Pyridoxi

1981
Bendectin and fetal malformations.
    Canadian Medical Association journal, 1981, Feb-01, Volume: 124, Issue:3

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

1981
Congenital symmetrical weakness of the upper limbs resembling brachial plexus palsy: a possible sequel of drug toxicity in first trimester of pregnancy?
    Neuromuscular disorders : NMD, 1995, Volume: 5, Issue:1

    Topics: Age of Onset; Antiemetics; Arm; Dermatoglyphics; Diagnosis, Differential; Dicyclomine; Doxylamine; D

1995
Science, law, and the search for truth in the courtroom: lessons from Daubert v. Merrell Dow.
    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 1994,Spring, Volume: 22, Issue:1

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Expert Testimo

1994
Admissibility of scientific testimony into evidence.
    American journal of hospital pharmacy, 1994, Mar-01, Volume: 51, Issue:5

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Drug Industry;

1994
Study of prescription drugs in the first trimester and congenital malformations.
    The Australian & New Zealand journal of obstetrics & gynaecology, 1993, Volume: 33, Issue:2

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Pregnancy;

1993
Environmental hazards: real or exaggerated?
    Science (New York, N.Y.), 1993, Oct-29, Volume: 262, Issue:5134

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Female; Hazardous Substances; Humans; Pregnancy; Pyridox

1993
Supreme Court to weigh science.
    Science (New York, N.Y.), 1993, Jan-29, Volume: 259, Issue:5095

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Expert Testimo

1993
Bringing scholarship to the courtroom: the Daubert decision and its impact on the Teratology Society.
    Teratology, 1995, Volume: 52, Issue:5

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Ethics, Professional; Expert Testimony; Female; Humans;

1995
Pregnancy outcome of women exposed to pinaverium due to a dispensing error.
    The Annals of pharmacotherapy, 1999, Volume: 33, Issue:1

    Topics: Antiemetics; Calcium Channel Blockers; Canada; Dicyclomine; Doxylamine; Drug Combinations; Female; F

1999
Attitudes, management and consequences of nausea and vomiting of pregnancy in the United States and Canada.
    International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2000, Volume: 70, Issue:3

    Topics: Adult; Antiemetics; Attitude; Attitude of Health Personnel; Canada; Cost of Illness; Dicyclomine; Di

2000
CDC study: no evidence for teratogenicity of Bendectin.
    JAMA, 1979, Dec-07, Volume: 242, Issue:23

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Heart

1979
Teratogenicity testing in humans: a method demonstrating safety of bendectin.
    Teratology, 1978, Volume: 17, Issue:1

    Topics: Abnormalities, Drug-Induced; Animals; Antiemetics; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylam

1978
Unusual fetal malformations after antiemetics in early pregnancy.
    British medical journal, 1978, Mar-18, Volume: 1, Issue:6114

    Topics: Abnormalities, Drug-Induced; Adult; Antiemetics; Dicyclomine; Doxylamine; Female; Humans; Pregnancy

1978
Fetal malformation after Debendox treatment in early pregnancy.
    British medical journal, 1978, Apr-22, Volume: 1, Issue:6119

    Topics: Abnormalities, Drug-Induced; Antiemetics; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug

1978
Congenital deformities associated with Benedectin.
    Canadian Medical Association journal, 1977, Jun-18, Volume: 116, Issue:12

    Topics: Abnormalities, Drug-Induced; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug Combinations

1977
Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score.
    American journal of obstetrics and gynecology, 1977, Jul-01, Volume: 128, Issue:5

    Topics: Abnormalities, Drug-Induced; Birth Weight; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Env

1977
Congenital deformities associated with Bendectin.
    Canadian Medical Association journal, 1977, Oct-08, Volume: 117, Issue:7

    Topics: Abnormalities, Drug-Induced; Adult; Cleft Lip; Cleft Palate; Cyclohexanecarboxylic Acids; Dicyclomin

1977
Prescription drugs in the first trimester and congenital malformations.
    The Australian & New Zealand journal of obstetrics & gynaecology, 1992, Volume: 32, Issue:4

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Ectromelia; Fe

1992
Risk, statistical inference, and the law of evidence: the use of epidemiological data in toxic tort cases.
    Risk analysis : an official publication of the Society for Risk Analysis, 1992, Volume: 12, Issue:3

    Topics: Abnormalities, Drug-Induced; Antiemetics; Confidence Intervals; Data Interpretation, Statistical; Di

1992
Use of prescription drugs in the first trimester and congenital malformations.
    The Australian & New Zealand journal of obstetrics & gynaecology, 1991, Volume: 31, Issue:4

    Topics: Abnormalities, Drug-Induced; Aspirin; Contraceptives, Oral; Dicyclomine; Female; Humans; Infant, New

1991
Potential risk factors for brain tumors in children. An analysis of 200 cases.
    Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery, 1990, Volume: 6, Issue:1

    Topics: Adolescent; Brain Neoplasms; Child; Dicyclomine; Doxylamine; Drug Combinations; Female; Glioma; Huma

1990
Drugs in pregnancy.
    Australian College of Midwives Incorporated journal, 1990, Volume: 2, Issue:4

    Topics: Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Hyperemesis Gravidarum; Pregnancy; Pyrid

1990
Bendectin--birth defects controversy.
    JAMA, 1990, Aug-01, Volume: 264, Issue:5

    Topics: Abnormalities, Drug-Induced; Animals; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Extre

1990
Key witness against morning sickness drug faces scientific fraud charges.
    JAMA, 1990, Mar-16, Volume: 263, Issue:11

    Topics: Animals; Antiemetics; Australia; Biomedical Research; Dicyclomine; Doxylamine; Drug Combinations; Fe

1990
Pharmacokinetics of doxylamine given as Bendectin in the pregnant monkey and baboon.
    Reproductive toxicology (Elmsford, N.Y.), 1989, Volume: 3, Issue:3

    Topics: Animals; Chromatography, Gas; Dicyclomine; Doxylamine; Drug Combinations; Female; Half-Life; Macaca

1989
Bendectin and human congenital malformations.
    Teratology, 1989, Volume: 40, Issue:2

    Topics: Abnormalities, Drug-Induced; Central Nervous System; Dicyclomine; Digestive System Abnormalities; Do

1989
Bendectin and interventricular septal defects.
    Teratology, 1985, Volume: 32, Issue:2

    Topics: Centers for Disease Control and Prevention, U.S.; Dicyclomine; Doxylamine; Drug Combinations; Female

1985
Agenesis of the corpus callosum and neural crest tumors.
    Pediatric hematology and oncology, 1986, Volume: 3, Issue:2

    Topics: Abdominal Neoplasms; Abnormalities, Drug-Induced; Agenesis of Corpus Callosum; Child; Child, Prescho

1986
Discontinuation of Bendectin.
    American journal of public health, 1988, Volume: 78, Issue:3

    Topics: Adult; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Pregnancy; P

1988
Factors associated with infantile hypertrophic pyloric stenosis.
    American journal of diseases of children (1960), 1988, Volume: 142, Issue:3

    Topics: Birth Order; Breast Feeding; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Hypertrophy

1988
Developmental toxicity evaluation of Bendectin in CD rats.
    Teratology, 1988, Volume: 37, Issue:6

    Topics: Abnormalities, Drug-Induced; Animals; Antiemetics; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylam

1988
The value of case reports in human teratology.
    American journal of obstetrics and gynecology, 1986, Volume: 154, Issue:3

    Topics: Abnormalities, Drug-Induced; Animals; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Eryth

1986
Debendox.
    The Medical journal of Australia, 1986, Mar-03, Volume: 144, Issue:5

    Topics: Abnormalities, Drug-Induced; Antiemetics; Cleft Lip; Cleft Palate; Dicyclomine; Doxylamine; Drug Com

1986
The management of nausea and vomiting during pregnancy.
    The Medical journal of Australia, 1987, Sep-21, Volume: 147, Issue:6

    Topics: Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Legislation, Drug; Nausea;

1987
Limb-reduction deformities and Debendox.
    The Medical journal of Australia, 1987, Oct-05, Volume: 147, Issue:7

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Infant, New

1987
The weight of the evidence--or--more likely than not.
    Journal of craniofacial genetics and developmental biology, 1986, Volume: 6, Issue:3

    Topics: Abnormalities, Drug-Induced; Dicyclomine; District of Columbia; Doxylamine; Drug Combinations; Femal

1986
Drugs and stillbirth.
    American journal of public health, 1986, Volume: 76, Issue:12

    Topics: Abnormalities, Drug-Induced; Adult; Anti-Bacterial Agents; Contraceptives, Oral; Dicyclomine; Doxyla

1986
The debendox saga.
    British medical journal (Clinical research ed.), 1985, Oct-05, Volume: 291, Issue:6500

    Topics: Abnormalities, Drug-Induced; Antiemetics; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans

1985
Debendox.
    The Medical journal of Australia, 1986, Jan-06, Volume: 144, Issue:1

    Topics: Abnormalities, Drug-Induced; Cyclohexanecarboxylic Acids; Dicyclomine; Doxylamine; Drug Combinations

1986
Jury clears Bendectin.
    Science (New York, N.Y.), 1985, Mar-29, Volume: 227, Issue:4694

    Topics: Abnormalities, Drug-Induced; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Jurispruden

1985
First-trimester drug use and congenital disorders.
    Obstetrics and gynecology, 1985, Volume: 65, Issue:4

    Topics: Abnormalities, Drug-Induced; Brompheniramine; Congenital Abnormalities; Dicyclomine; Doxylamine; Dru

1985
Congenital heart disease in relation to maternal use of Bendectin and other drugs in early pregnancy.
    The New England journal of medicine, 1985, Aug-08, Volume: 313, Issue:6

    Topics: Acetaminophen; Adult; Anti-Bacterial Agents; Antiemetics; Aspirin; Dicyclomine; Doxylamine; Drug Com

1985
Blame, compensation and birth defects.
    The Medical journal of Australia, 1985, Aug-19, Volume: 143, Issue:4

    Topics: Abnormalities, Drug-Induced; Australia; Congenital Abnormalities; Dicyclomine; Doxylamine; Drug Comb

1985
Debendox revisited.
    British journal of obstetrics and gynaecology, 1985, Volume: 92, Issue:8

    Topics: Abnormalities, Drug-Induced; Antiemetics; Cleft Lip; Cleft Palate; Dicyclomine; Doxylamine; Drug Com

1985
Evaluation of bendectin embryotoxicity in nonhuman primates: I. Ventricular septal defects in prenatal macaques and baboon.
    Teratology, 1985, Volume: 32, Issue:2

    Topics: Animals; Dicyclomine; Dose-Response Relationship, Drug; Doxylamine; Drug Combinations; Female; Fetus

1985
Evaluation of bendectin embryotoxicity in nonhuman primates: II. Double-blind study in term cynomolgus monkeys.
    Teratology, 1985, Volume: 32, Issue:2

    Topics: Animals; Brain; Dicyclomine; Dose-Response Relationship, Drug; Double-Blind Method; Doxylamine; Drug

1985
Inter-Regional Epidemiological Study of Childhood Cancer (IRESCC): childhood cancer and the consumption of debendox and related drugs in pregnancy.
    British journal of cancer, 1985, Volume: 52, Issue:6

    Topics: Adolescent; Antiemetics; Child; Cyclohexanecarboxylic Acids; Dicyclomine; Dose-Response Relationship

1985