Report a side effect with a medicine or medical device. The MHRA products website allows you to find: You can look for any word, phrase or Product Licence number (PL) using the search tool. You We don’t fully understand the risks of taking gabapentin during pregnancy yet. The MHRA was not able to make any firm conclusions about its safety in pregnancy. The risks of birth defects or issues with learning and thinking cannot be confirmed or ruled out. There's no evidence to suggest that taking gabapentin reduces fertility in either men or women. However, discuss your pregnancy plans with a doctor. They may wish to review your medicine and prescribe a higher dose of folic acid for you to take (5mg a day) before you become pregnant. On this basis, data on the use of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, pregabalin, topiramate, and zonisamide in pregnancy were reviewed. • Gabapentin (brand names Lecomig, Neurontin) and pregabalin (brand name Alzain, Axalid, Lecaent, Lyrica) - risks during pregnancy are not yet fully understood. Some data suggest that taking We sought to evaluate the association between gabapentin exposure during pregnancy and risk of adverse neonatal and maternal outcomes. Using the United States Medicaid Analytic eXtract (MAX) dataset, we conducted a population-based study of 1,753,865 Medicaid-eligible pregnancies between January 2000 and December 2013. Gabapentin (brand names Lecomig, Neurontin) and pregabalin (brand name Alzain, Axalid, Lecaent, Lyrica) – risks during pregnancy are not yet fully understood; some data suggest that taking All pregnant women in the UK will be offered a very detailed anomaly scan at around 20 weeks of pregnancy as part of their routine antenatal care. No extra monitoring for major birth defects is required following gabapentin use in pregnancy. Babies exposed to gabapentin before delivery may experience withdrawal symptoms for a few days after birth. The MHRA is instructing doctors to discuss with women both the risks associated with antiepileptic drugs and with untreated epilepsy during pregnancy. Women who are planning to start a family should be urgently referred for specialist advice on their antiepileptic treatment. The MHRA has considered the recommendations of the European review, together with the other limited safety data available regarding pregabalin safety in pregnancy, and agreed that the product MHRA/CHM advice: Gabapentin (Neurontin®) and risk of abuse and dependence: new scheduling requirements from 1 April (April 2019) Following concerns about abuse, gabapentin has been reclassified as a Class C controlled substance and is now a Schedule 3 drug, but is exempt from safe custody requirements. Pregnancy-related problems, such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth) have been reported in some studies looking at the use of gabapentin during pregnancy. Gabapentin and pregabalin – the risks of taking these during pregnancy are not yet fully understood; some research suggests that taking pregabalin during pregnancy may slightly increase in pregnancy had increased over the 10-year period (up to 2015/2016) and that exposure to pregabalin in pregnancy was most frequent in the first trimester. Prescribers of these medicines should continue to follow the current recommendations on Following a national review into the safety of antiepileptic drugs in pregnancy, including New Safer Medicines in Pregnancy and Breastfeeding Consortium. On 11 January 2021, the MHRA and partner organisations launched a major new initiative to ensure pregnant and breastfeeding women can Gabapentin should only be used during pregnancy where benefits of treatment are considered to outweigh any potential risks. In view of the limited human pregnancy data, close monitoring of mother and fetus should be considered with use of gabapentin in pregnancy. In April 2022, the MHRA reviewed the findings of a new safety study that suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. pregnancy MHRA UK Public Assessment Report January 2021 Contents Plain Language Summary 2 Introduction 4 Summaries of main evidence and key findings 5 3.1 Carbamazepine 6 3.2 Gabapentin 7 3.3 Lamotrigine 8 3.4 Levetiracetam 9 3.5 Oxcarbazepine 9 3.6 Phenobarbital 10 3.7 Phenytoin 11 3.8 Pregabalin 12 3.9 Topiramate 13 Pregabalin (Lyrica), gabapentin (Neurontin) and risk of abuse and dependence: new scheduling requirements from 1 April 2019 page 9 Elvitegravir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 page 12 In this study, 6 babies in 100 born to women who took pregabalin in the first 3 months of pregnancy had physical birth abnormalities, compared to 4 babies in every 100 born to women who were not
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