id | Study | Lib. in paper | Exposition period | Study type |
Control type |
Tags | OR 95%CI | x1/n1 x0/n0 | no cases | no exposed | ROB | Ref. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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S10233 R37493 |
The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
3.32 [1.72;6.40] C excluded (control group) |
12/200 44/2,333 | 56 | 200 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10234 R37495 |
The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 6.32 [2.80;14.29] C | 12/200 12/1,201 | 24 | 200 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12836 R48362 |
Thomas (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
3.04 [0.37;24.93] C excluded (control group) |
8/137 1/50 | 9 | 137 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12837 R48370 |
Thomas (Phenobarbital) (Controls unexposed, disease free), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
1.57 [0.62;3.97] excluded (control group) |
7/129 11/319 | 18 | 129 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12838 R48374 |
Thomas (Phenobarbital) (Controls unexposed, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: Yes | 1.20 [0.50;2.70] | 8/137 16/340 | 24 | 137 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9152 R35157 |
Vajda (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
6.27 [0.25;158.67] C excluded (control group) |
0/2 20/406 | 20 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9153 R35158 |
Vajda (Phenobarbital) (Controls unexposed, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 10.33 [0.38;283.37] C | 0/2 5/176 | 5 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9151 R31465 |
Tomson (Phenobarbital), 2018 | Major congenital malformation | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 2.28 [1.36;3.83] C | 19/294 74/2,514 | 93 | 294 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9098 R31165 |
Barroso (Phenobarbital), 2015 | Major anomalies | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, disease free | Adjustment: No |
2.11 [0.68;6.62] C excluded (exposition period) |
4/32 20/316 | 24 | 32 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9118 R31331 |
Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | Major congenital malformation | throughout pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
2.30 [0.52;10.19] C excluded (control group) |
2/27 28/833 | 30 | 27 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9119 R31333 |
Veiby (Phenobarbital) (Controls unexposed, disease free) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
2.75 [0.65;11.60] excluded (control group) |
2/27 22,371/771,412 | 22,373 | 27 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9120 R31336 |
Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 2.77 [0.65;11.84] C | 2/27 106/3,773 | 108 | 27 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9175 R31622 |
Cassina (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Other indications), 2013 | Major congenital anomalies | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
6.43 [0.11;379.68] C excluded (control group) |
0/4 0/23 | 0 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9176 R31624 |
Cassina (Phenobarbital) (Controls unexposed, disease free) (Other indications), 2013 | Major congenital anomalies | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 4.36 [0.22;86.56] C | 0/4 25/803 | 25 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9111 R31308 |
Källén (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
3.77 [0.83;17.10] C excluded (control group) |
2/17 37/1,084 | 39 | 17 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9112 R31310 |
Källén (Phenobarbital) (Controls unexposed, NOS) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: No | 4.11 [0.94;17.98] C | 2/17 49,499/1,575,847 | 49,501 | 17 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9124 R35121 |
Bànhidy (Phenobarbital), 2011 | Total congenital abnormalities | throughout pregnancy | case control | unexposed, sick | Adjustment: No Matched | 2.48 [0.09;68.14] C | 1/1 12/22 | 13 | 1 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9099 R31168 |
Burja (Phenobarbital) (Controls unexposed, disease free), 2006 | Congenital malformation | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, disease free excluded | Adjustment: No |
37.36 [0.68;2061.38] C excluded (control group) |
0/1 5/211 | 5 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9100 R31173 |
Burja (Phenobarbital) (Controls unexposed, sick), 2006 | Congenital malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort (registry) | unexposed, sick | Adjustment: No |
63.00 [0.51;7760.63] C excluded (exposition period) |
0/1 0/32 | 0 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9104 R31262 |
Endo (Phenobarbital) (Controls unexposed, disease free), 2004 | Congenital malformations | throughout pregnancy | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
1.20 [0.07;21.20] C excluded (control group) |
0/10 27/656 | 27 | 10 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9105 R31277 |
Endo (Phenobarbital) (Controls unexposed, sick), 2004 | Congenital malformations | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.05 [0.00;6.68] C | 0/10 0/1 | 0 | 10 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9130 R31365 |
Kaaja (Phenobarbital), 2003 | Major malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 10.51 [0.44;251.86] C | 0/5 2/239 | 2 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9103 R31249 |
Dean (Phenobarbital), 2002 | Congenital malformations (major and minor) | at least 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 4.01 [1.53;10.50] C | 29/61 7/38 | 36 | 61 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9109 R31297 |
Holmes (Phenobarbital) (Controls unexposed, disease free), 2001 | Major malformations | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, disease free excluded | Adjustment: Yes |
2.70 [0.60;16.40] excluded (control group) |
3/64 9/508 | 12 | 64 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9110 R31306 |
Holmes (Phenobarbital) (Controls unexposed, sick), 2001 | Major malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
11.28 [0.57;222.22] C excluded (exposition period) |
3/64 0/98 | 3 | 64 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9097 R31161 |
Al Bunyan (Phenobarbital), 1999 | Congenital malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
6.33 [0.09;458.24] C excluded (exposition period) |
0/2 0/10 | 0 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9126 R31358 |
Canger (Phenobarbital), 1999 | All type of malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 2.81 [0.15;54.03] C | 4/83 0/25 | 4 | 83 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9131 R31366 |
Kaneko (Phenobarbital), 1999 | Malformations | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 1.58 [0.34;7.28] C | 4/84 3/98 | 7 | 84 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9145 R31446 |
Samrén (Phenobarbital), 1999 | Major congential abnormalities | at least 1st trimester | retrospective cohort | unexposed, disease free | Adjustment: No Matched | 1.96 [0.75;5.14] C | 5/178 29/2,000 | 34 | 178 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9146 R31448 |
Steegers-Theunissen (Phenobarbital), 1994 | Major malformations (ICD9 British Paediatric Association System) | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, disease free | Adjustment: No |
1.80 [0.08;39.83] C excluded (exposition period) |
0/12 2/106 | 2 | 12 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9101 R31176 |
D'Souza (Phenobarbital) (Controls unexposed, disease free), 1991 | Congenital anomalies | throughout pregnancy | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
73.80 [2.36;2304.87] C excluded (control group) |
1/4 0/62 | 1 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9102 R31205 |
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 | Congenital anomalies | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 2.33 [0.11;50.99] C | 1/4 1/8 | 2 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9144 R31444 |
Robert (Phenobarbital), 1986 | Congenital malformations (minor and major) | 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 1.37 [0.35;5.31] C | 6/40 4/35 | 10 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9132 R31373 |
Kelly (Phenobarbital), 1984 | Major abnormality | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.52 [0.02;13.80] C excluded (exposition period) |
0/13 1/21 | 1 | 13 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9136 R31377 |
Lowe (Phenobarbital) (Controls unexposed, disease free), 1973 | Malformations | 1st trimester | population based cohort retrospective | unexposed, disease free excluded | Adjustment: No |
0.68 [0.09;4.95] C excluded (control group) |
1/53 865/31,632 | 866 | 53 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9137 R31379 |
Lowe (Phenobarbital) (Controls unexposed, sick), 1973 | Malformations | 1st trimester | population based cohort retrospective | unexposed, sick | Adjustment: No | 0.69 [0.07;6.82] C | 1/53 3/111 | 4 | 53 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 17 studies | 2.49 [1.85;3.35] | 49,892 | 1,200 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives |
1: Controls unexposed, disease free) (Indications NOS; 2: Phenobarbital) (Controls unexposed, sick; 3: Phenobarbital) (Controls unexposed, sick; 4: Phenobarbital; 5: Phenobarbital) (Controls unexposed, sick) (Mixed indications; 6: Phenobarbital) (Controls unexposed, disease free) (Other indications; 7: Phenobarbital) (Controls unexposed, NOS) (Indications NOS; 8: Phenobarbital; 9: Phenobarbital) (Controls unexposed, sick; 10: Phenobarbital; 11: Phenobarbital; 12: Phenobarbital; 13: Phenobarbital; 14: Phenobarbital; 15: Phenobarbital) (Controls unexposed, sick; 16: Phenobarbital; 17: Phenobarbital) (Controls unexposed, sick;
Asymetry test p-value = 0.8446 (by Egger's regression)
slope=0.9598 (0.2843); intercept=-0.0916 (0.4590); t=0.1995; p=0.8446
excluded 9136, 9101, 9109, 9104, 9099, 9175, 9111, 9118, 9119, 9152, 12836, 12837, 10233