Utilization of Topiramate During Pregnancy and Risk of Birth Defects

Green, Mark W.; Seeger, John D.; Peterson, Craig A.; Bhattacharyya, Arun

doi:10.1111/j.1526-4610.2012.02190.x

Cited by 31 publications

(20 citation statements)

References 24 publications

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“…Among 108 infants exposed to topiramate, five were malformed (OR = 1.44, 95% CI 0.58–3.58) [41] and another study found 15 malformed infants among 359 exposed with an RR of 2.2 (1.2–4.0) and noticed an increased risk for cleft lip [35]. The total malformation rate after topiramate exposure in monotherapy was 4.33% against 3.77% in unexposed infants but no specific effect on orofacial clefts was seen [51]. In retrospectively collected data an OR of 5.4 (95% CI 1.5–20.1) for cleft lip/palate was found after topiramate exposure [52].…”

Section: Resultsmentioning

confidence: 99%

The Use of Central Nervous System Active Drugs During Pregnancy

2013

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CNS-active drugs are used relatively often during pregnancy. Use during early pregnancy may increase the risk of a congenital malformation; use during the later part of pregnancy may be associated with preterm birth, intrauterine growth disturbances and neonatal morbidity. There is also a possibility that drug exposure can affect brain development with long-term neuropsychological harm as a result. This paper summarizes the literature on such drugs used during pregnancy: opioids, anticonvulsants, drugs used for Parkinson’s disease, neuroleptics, sedatives and hypnotics, antidepressants, psychostimulants, and some other CNS-active drugs. In addition to an overview of the literature, data from the Swedish Medical Birth Register (1996–2011) are presented. The exposure data are either based on midwife interviews towards the end of the first trimester or on linkage with a prescribed drug register. An association between malformations and maternal use of anticonvulsants and notably valproic acid is well known from the literature and also demonstrated in the present study. Some other associations between drug exposure and outcome were found.

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Section: Resultsmentioning

confidence: 99%

The Use of Central Nervous System Active Drugs During Pregnancy

2013

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“…Although the available evidence for an association between intrauterine TPM exposure and hypospadias is based on relatively small numbers of instances and needs to be confirmed in larger studies before it can be regarded as persuasive, it does raise concerns about the possible use of the drug during pregnancy, particularly when it is becoming more widely employed as a migraine preventative. In relation to migraine, Green et al (21) went into the matter of the risk of oral clefts and other major congenital malformations and concluded that TPM was no worse than other AEDs in these regards. The data of Fig.…”

Section: Discussionmentioning

confidence: 99%

Associations between particular types of fetal malformation and antiepileptic drug exposurein utero

et al. 2013

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Associations between particular types of fetal malformation and antiepileptic drug exposure in utero Objective -To study associations between patterns of fetal malformation and individual antiepileptic drugs taken during pregnancy. Methods -Multiple variable logistic regression and other statistical analyses of data relating to 1733 fetuses from 1703 pregnancies (147 of which were not exposed to antiepileptic drugs during pregnancy). Results -There were statistically significant (P < 0.05) associations between (i) valproate exposure and spina bifida, malformations of the heart and great vessels, digits, skull bones, and brain, but not hypospadias, cleft palate/lip and mouth abnormalities, (ii) topiramate exposure and hypospadias and brain maldevelopments, and (iii) carbamazepine (CBZ) exposure and renal tract abnormalities. Conclusions -The valproate findings are mostly in keeping with the published literature, but the topiramate finding regarding hypospadias and the association between CBZ exposure and various renal tract abnormalities raise questions of organ specific teratogenesis. More extensive data are desirable, particularly in relation to topiramate, which is being used increasingly as a migraine prophylactic in women of childbearing potential.

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“…Teratogenicity data derived from epidemiologic studies and claims data in women using immediate-release topiramate for approved migraine and epilepsy indications showed an increased risk of cleft lip with or without cleft palate in infants exposed to topiramate during the first trimester of pregnancy [31]. However, a subsequent retrospective analysis that quantified the association between topiramate exposure during pregnancy and the risk of oral cleft or major congenital malformations found little or no increase in risk when compared with exposure to other anti-epileptic drugs [31].…”

Section: Regulatory Affairsmentioning

confidence: 99%

“…However, a subsequent retrospective analysis that quantified the association between topiramate exposure during pregnancy and the risk of oral cleft or major congenital malformations found little or no increase in risk when compared with exposure to other anti-epileptic drugs [31]. The FDA approval of phentermine/topiramate ER in July 2012 included a risk evaluation and mitigation strategy (REMS) to inform patients and providers about teratogenic risk and the need to avoid fetal exposure [9].…”

Section: Regulatory Affairsmentioning

confidence: 99%

Phentermine and topiramate extended-release: a new treatment for obesity and its role in a complications-centric approach to obesity medical management

Garvey¹

2013

Expert Opinion on Drug Safety

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Introduction: Weight-management options include lifestyle modifications, bariatric surgery and, until recently, limited pharmacotherapy. (phentermine/topiramate ER) has recently been approved in the USA for chronic weight management in obese adults and overweight adults with weight-related co-morbidities in conjunction with a reduced-calorie diet and increased physical activity.Areas covered: This review describes the pharmacology and clinical trials data for phentermine/topiramate ER and its role in a complications-centric approach to medical care of the overweight and obese patient.Expert opinion: Phentermine/topiramate ER is an effective and safe weight-loss medication that can produce and sustain approximately 10% loss of body weight. This is a landmark development in the pharmacotherapy of obesity. By offering an effective medical option to complement lifestyle and surgical approaches, phentermine/topiramate ER enables a comprehensive medical model for obesity care. The overall approach to the overweight and obese patient should be to identify individuals who will benefit most from therapy based on cardiometabolic or mechanical complications, establish therapeutic targets and goals for ameliorating these complications and selecting the treatment modality and intensity for weight loss to achieve these goals. This complications-centric model emphasizes weight loss as a tool to ameliorate obesity-related complications and optimizes benefit/risk for achieving the best outcomes in overweight/obese patients.

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Utilization of Topiramate During Pregnancy and Risk of Birth Defects

Cited by 31 publications

References 24 publications

The Use of Central Nervous System Active Drugs During Pregnancy

The Use of Central Nervous System Active Drugs During Pregnancy

Associations between particular types of fetal malformation and antiepileptic drug exposurein utero

Phentermine and topiramate extended-release: a new treatment for obesity and its role in a complications-centric approach to obesity medical management

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