Pregabalin (All indications)

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)1.87 [0.83, 4.23]53%7 studies115,749698not evaluable ROB-
Major congenital malformations1.87 [0.83, 4.23]53%7 studies115,749698not evaluable ROB-
Oro-facial clefts1.89 [0.35, 10.09]29%2 studies2,8191,701not evaluable ROB-
Spina bifida4.33 [0.49, 38.62]37%2 studies6201,701not evaluable ROB-
Coarctation of aorta5.80 [1.90, 17.70]-1 study7831,671not evaluable ROB11.08 [3.21; .]
Congenital heart defects--0 study-
Craniosynostosis4.40 [1.16, 16.72]-1 study7691,671not evaluable ROB8.27 [1.59; .]
Digestive system anomalies--0 study-
Eye defects--0 study-
Genital anomalies--0 study-
Limb defects--0 study-
Nervous system anomalies--0 study-
Urinary malformations--0 study-
Respiratory system anomalies--0 study-
20 non statistically significant endpoints reported in only one study

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low birth weight (< 2500g)1.67 [0.79, 3.54]36%2 studies91,8241,640not evaluable ROB-
Preterm (< 37 weeks)1.83 [0.67, 5.00]63%2 studies91,7511,640not evaluable ROB-
Small for gestational age (weight)1.22 [0.77, 1.93]20%2 studies168,1501,640not evaluable ROB-
3 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)--0 study-
1 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
1 non statistically significant endpoints reported in only one study

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Late intrauterine deaths (> 22 weeks)--0 study-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis0.99 [0.56, 1.74]43%2 studies4,5703,293not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk0.99 [0.56, 1.74]43%2 studies4,5703,293not evaluable ROB-
Neuro-developmental disorders (as a whole)0.95 [0.54, 1.68]67%2 studies10,4943,293not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis--0 study-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk--0 study-
5 non statistically significant endpoints reported in only one study