What you need to know before you take
Warnings and precautions can cause harm to an unborn baby. Traditionally, MMI has been considered to have clearer evidence of teratogenicity than PTU. How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. To report an exposure please download and complete a pregnancy reporting form. The pregnancy rate was 33.3% in treated women compared to 8.4% in the placebo group (p = 0.03). A large number of case reports (>70) and numerous case-control and cohort studies have linked exposure to carbimazole/methimazole (CMZ/MMI) during early pregnancy with an embryopathy that incorporates a number of birth defects including aplasia cutis, choanal atresia, gastrointestinal anomalies and abdominal wall defects. QJM 2012; 105:189. Antithyroid Drug (ATD) Therapy of Hyperthyroidism in Pregnancy. It has (rarely) been associated with congenital defects, including aplasia cutis of the neonate but is not contra-indicated. Carbamazepine has been viewed by many as the antiepileptic drug (AED) of choice during pregnancy, 1 as there are more studies on the fetal outcomes associated with in utero CBZ monotherapy compared with other AEDs. The lowest dose possible should be used, and this can often be discontinued three to four weeks before term, in order to reduce the risk of neonatal complications. USE OF CARBIMAZOLE/METHIMAZOLE IN PREGNANCY. But the lowest possible dose should be given. It has (rarely) been associated with congenital defects, including aplasia cutis of the neonate but is not contra-indicated. Bowman P, Vaidya B. Bowman P, Osborne NJ, Sturley R, Vaidya B. Carbimazole embryopathy: implications for the choice of antithyroid drugs in pregnancy. Q: Will the consumption of NeoMercazole medicine before and during pregnancy affect the pregnancy test and the unborn baby? There is concern over whether carbimazole/methimazole or propylthiouracil is the most appropriate antithyroid drug to use when treating hyperthyroidism in pregnant women. I worried that this would have caused harm to my baby as I shouldn’t have conceived whilst taking carbimazole. Carbimazole is associated with an increased risk of congenital malformations when used during pregnancy, especially in the first trimester and at high doses (daily dose of 15 mg or more). Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. There are TWO separate issues. Carbimazole is used to treat an overactive thyroid gland (hyperthyroidism). Thyroid diseases are among the most common endocrine disorders encountered during pregnancy. My son was born at full term with no … Carbimazole is associated with an increased risk of congenital malformations when used during pregnancy, especially in the first trimester and at high doses (daily dose of 15 mg or more). Because of the risk of teratogenesis when carbimazole is used in pregnancy, propylthiouracil is preferred for treating thyrotoxicosis in the first trimester. Impact of Carbimazole, Thiamazole (Methimazole) during pregnancy on fetal development, risk of stillbirth, malformation or birth defects. If carbimazole is used in pregnancy, the dose must be regulated by the patient's clinical condition. If present, then referral to a fetal medicine unit is indicated. This document is regularly reviewed and updated. Endocrine disorders are a significant reason for consultation during pregnancy. A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records. Following absorption, carbimazole is rapidly and completely metabolised to methimazole, which inhibits the synthesis of the thyroid hormones thyroxine (T4) and triiodothyronine (T3). Join my bumps. Close maternal, foetal and neonatal monitoring is warranted (see Section 4.6 Fertility, pregnancy and lactation, Use in pregnancy). Fast Home Delivery with COD No Minimum Order Flat 18% OFF* on all medicines India's Most Trusted Medical Store If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant. nfoulds@sghms.ac.uk Concerns about the safety of carbimazole in pregnancy were raised in 1985. This is a UKTIS monograph for use by health care professionals. If carbimazole is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended (see section 4.4). Read about its interactions, intake instructions and how Carbimazole works only on PharmEasy. Fetal hyperthyroidism can be life-threatening, and needs to be recognised as soon as possible so that treatment of the fetus with antithyroid drugs via … ; Long-term management of hyperthyroidism may include drugs that suppress thyroid function such as propylthiouracil, carbimazole and methimazole . Advice for healthcare professionals. Treatment with carbimazole, methimazole or other antithyroid medicines after week 10 of pregnancy can affect the development of the unborn baby’s thyroid gland. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider. However, please let us know if you are planning to conceive or as soon as you know you are pregnant. Carbimazole is used for hyperthyroidism and other conditions. It is important to understand that scans are unlikely to detect some of the birth defects that have been linked to carbimazole and cannot rule out that a baby will have problems with learning. If you have any questions regarding the information in this leaflet please discuss them with your health care provider. Please encourage all women to complete an online reporting form. Carbimazole and Methimazole cross the placenta and may cause fetal hypothyroidism and abnormalities. However, controlled epidemiological studies have not confirmed this association, but these data are also limited. fewer than after PTU use). Before using Carbimazole, inform your doctor about your current list of medications, over the counter products (e.g. First, the increased possibility of congenital malformations if taken when pregnant. If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist. More research is required before we can say whether taking carbimazole in pregnancy is specifically linked to low birth weight in the baby. However, none of four small scientific studies have shown that children exposed to carbimazole or methimazole in the womb are more likely to have problems with learning and behaviour than children not exposed to these medicines. Thankfully I switched to PTU again and felt much better than my first pregnancy. Therefore, women treated with carbimazole or methimazole at this stage of pregnancy are likely to be offered additional ultrasound scans to assess the growth and well-being of the baby. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour. These defects have been seen to occur either in isolation or in combination, and in some cases with facial dysmorphisms and developmental delay. Carbimazole (Neomercazole) is converted into methimazole after it is absorbed. 4.5 Interaction with other medicines and other forms of interaction Little is known about interactions. It is important that normal thyroid function is maintained during pregnancy as the effects of an overactive thyroid can be harmful to both mother and unborn child. Carbimazole can harm an unborn child so you must avoid getting pregnant while you are taking it. Background: Hyperthyroidism is one of the most common endocrine disorders in pregnant women, and it can severely complicate the course and outcome of pregnancy. Methimazole (MMI) and propylthiouracil (PTU) are the standard anti-thyroid drugs used in the treatment of hyperthyroidism in pregnancy. Methimazole, carbimazole, and congenital skin defects. However, if you would like to, you can change your cookie settings at any time. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments. If you are a woman and want to have a family, discuss this with your doctor so that you can be given advice from a specialist before you become pregnant. Pre-conception patients may be offered definitive therapy - eg, ablation with radiotherapy (ideally, the patient should not conceive until six months later, once the levothyroxine dose has been optimised). Consult a doctor before its use if: You are pregnant, planning for it or are breastfeeding ; … Carbimazole should be used judiciously in pregnancy as it crosses the placenta. None of the 12 infants, including one set of twins, had a serum thyroxine (T4) concentration below the lower limit of normal on day 4 of life. 4.5 Interaction with other medicines and other forms of interaction Little is known about interactions. More research is required before we can say whether carbimazole or methimazole use during pregnancy increases the chance of learning and behavioural problems in the child, and whether learning and behavioural problems can occur in carbimazole/methimazole-exposed children who do not have structural birth defects. During pregnancy, it is recommended that the dose of propylthiouracil and carbimazole is kept to the lowest possible needed to maintain euthyroidism, as these drugs cross the placenta and in high doses may cause fetal goitre and hypothyroidism. 2 Treatment of active epilepsy is important during pregnancy because seizures can lead to falls, injury, and physical stress that can endanger the health of the woman and … It is critical that maternal hyperthyroidism during pregnancy receives appropriate treatment, as it has been associated with maternal complications including hypertension, thyroid storm, heart failure, preterm labour, pre-eclampsia and placental abruption. Risk with carbimazole. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby. Suspected Spontaneous Reports of Birth Defects in the UK Associated with the Use of Carbimazole and Propylthiouracil in Pregnancy. This accounts for the dramatic improvement in both subjective and objective symptoms of hyperthyroidism, … The antithyroid drugs, Carbimazole, Methimazole, and Propylthiouracil remain the mainstay of Graves' disease management in pregnancy. Noted fetal and neonatal complications include stillbirth, intrauterine growth restriction, low birth weight, heart failure and goitre. Women of childbearing potential unless they are using effective contraception — carbimazole is associated with an increased risk of congenital malformations when used during the first trimester of pregnancy and at high doses. This should be offered to all women. Thiamazole (methimazole) and carbimazole. Use of carbimazole in pregnancy, especially during the first trimester, and at doses greater than 15mg per day, is associated with an increased risk of congenital malformations. More research is required before firm conclusions can be drawn. Click Here to Manage Email Alerts Back to Healio High levels of maternal thyroid hormones may also lead to abnormal fetal thyroid development and some studies have linked maternal hyperthyroidism during pregnancy to congenital malformations in the infant.
Carbimazole is an antithyroid medicine, which is used for treating hyperthyroidism. There are, however, some medicines that can harm a baby’s normal development. The mother could then be treated with carbimazole from the second trimester throughout the remainder of the pregnancy, reducing the time of exposure of mother and fetus to the potentially hepatotoxic effects of propylthiouracil. Package leaflet . Advice for healthcare professionals. Read about its interactions, intake instructions and how Carbimazole works only on PharmEasy. Close maternal, fetal and neonatal monitoring is warranted (see section 4.6 Fertility, pregnancy and lactation). Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version. None of the 12 infants, including one set of twins, had a serum thyroxine (T4) concentration below the lower limit of normal on day 4 of life. However, in Graves' disease the thyroid-stimulating antibody crosses the … For case-specific advice please contact UKTIS on 0344 892 0909. Worldwide, the thionamides-propylthiouracil, methimazole, and carbimazole-have been used in pregnancy for the treatment of hyperthyroidism. Finally, a number of case reports have linked in utero CMZ/MMI exposure to developmental delay in children, most of whom had structural birth defects. Carbimazole should be used judiciously in pregnancy as it crosses the placenta. In early pregnancy (0–18 days), drugs that affect cell division (e.g. Carbimazole does cross the placenta and there have been rare instances of babies born with nail/finger abnormalities (aplasia cutis) while on carbimazole. If you have taken carbimazole, methimazole or other antithyroid medicines) after week 10 of pregnancy your baby will require extra monitoring after birth because of the risk of altered thyroid function. They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account. However, hepatotoxicity is a rare side effect of PTU and a single study has associated its use with congenital malformations, although the evidence suggesting a risk of malformations is less convincing than the evidence concerning CMZ/MMI. Where exposure to CMZ/MMI has occurred in the first trimester, a routine 20-week anomaly scan should be offered, although it should be noted that some CMZ/MMI-associated defects would be unlikely to be detected. Features of fetal hyper- and hypothyroidism (goitre, tachycardia, hydrops, bone maturity) can also be detected on serial scanning. There is no firm evidence to link CMZ/MMI exposure during pregnancy to miscarriage, perinatal death and premature delivery, although for most of these outcomes data are inadequate to permit a full and accurate risk assessment. Learning and behavioural problems A baby’s brain continues to develop right up until the end of pregnancy. Carbimazole and methimazole use in early pregnancy appears to occasionally cause certain birth defects in the baby. If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered. When deciding whether or not to take carbimazole during pregnancy your doctor will help you to weigh up how necessary carbimazole is to your health against the possible risks to you or your baby, some of which will depend on how many weeks pregnant you are. Treatment of graves' disease with antithyroid drugs in the first trimester of pregnancy and the prevalence of congenital malformation. Carbimazole may still be used during pregnancy at low doses and under close medical supervision. It is currently unclear whether taking carbimazole or methimazole in pregnancy is linked to low birth weight in the baby because the results of the studies that have investigated this do not all agree. … Yoshihara A, Noh J, Yamaguchi T, et al. Close maternal, fetal and neonatal monitoring is warranted (see section 4.6 Fertility, pregnancy and lactation). Sometimes this may have beneficial effects for the baby. Although the relative risk of these specific and often rare malformations appears to be greatly increased following exposure to CMZ/MMI, one large study has estimated that <2% of infants exposed to CMZ/MMI in utero will have at least one of these malformations, suggesting that teratogenic effects are relatively uncommon and the absolute risk of embryopathy is low. 2. To have your say on how we can improve our website and the information we provide please visit here. However, it more predictably may cause fetal hypothyroidism so (in minimal doses) it can be used in order to control maternal hyperthyroidism. Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. WE NEED YOUR HELP! 2. If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy. If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered. Re-exposure to carbimazole may result in life-threatening acute pancreatitis. General pregnancy and pre-conception advice to all women - eg, folic acid. Provide information about your pregnancy to help women in the future. Carbimazole crosses the placenta but, provided the mother's dose is within the standard range and her thyroid status is monitored; there is no evidence of neonatal thyroid abnormalities. There is no strong evidence from a number of studies that use of carbimazole or methimazole in pregnancy is linked to preterm birth. Traditionally, MMI has been considered to have clearer evidence of teratogenicity than PTU. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date. Carbimazole and methimazole are thionamide antithyroid agents used in the management of hyperthyroidism and licensed for the treatment of Graves’ disease, in the preparation of hyperthyroid patients for thyroidectomy, and as an adjunct to radioiodine therapy. Please encourage all women to complete an online reporting form. For some women carbimazole or methimazole may be considered the best medicines to maintain normal thyroid function during pregnancy. pregnancy, upcoming surgery, etc. The potential risks and benefits of PTU over CMZ should be made on an individual patient basis. In many women, thyroid dysfunction diminishes as the … A series of Clinical Practice Guidelines aimed at optimising fetal and maternal outcomes in women with Graves' disease have been published in recent years. Lancet 1992; 339:742. Newborn babies of women with Graves’ disease may also experience other thyroid problems. If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy. Most medicines used by the mother will cross the placenta and reach the baby. Studies suggest that fewer than two in every hundred babies who are exposed to carbimazole in the womb are born with these defects. Pregnancy. cytotoxic agents, folate antagonists) may affect formation of the blastocyst and cause fetal death. Thyrotr… Foulds N(1), Walpole I, Elmslie F, Mansour S. Author information: (1)SW Thames Regional Genetics Services, St. George's Hospital, London, UK. Login to my bumps
It is mainly during this time that some medicines are known to cause birth defects. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org. The MHRA said an EU review of evidence from epidemiological studies and case reports showed that carbimazole is associated with an increased risk of congenital malformations when used during pregnancy, especially during the first trimester and at high dosages (≥15mg daily). March 12, 2019. Pregnancy loss rates were not significantly different between the two groups. vitamins, herbal supplements, etc. Thyroid-stimulating hormone (TSH) levels should ideally be less than 2.5 mIU/L in those women taking levothyroxine prior to conception[1]. Asher Ornoy, Corinna Weber-Schöndorfer, in Drugs During Pregnancy and Lactation (Third Edition), 2015. Therefore, carbimazole should be used in pregnancy only when propylthiouracil is not suitable. Eleven mothers were taking oral carbimazole in dosages ranging from 5 to 20 mg daily during pregnancy and 5 to 15 mg daily during breastfeeding (extent not stated). Q: Will the consumption of NeoMercazole medicine before and during pregnancy affect the pregnancy test and the unborn baby? Carbimazole - Learn about Carbimazole including its uses, composition, side-effects, dosage, precautions & FAQs. If you have taken carbimazole or methimazole after week 10 of pregnancy, and/or if you have Graves’ disease, your baby’s thyroid function should be monitored after delivery. Carbimazole is a pro-drug that is rapidly metabolised to thiamazole, an anti-thyroid agent that … If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered. A corresponding patient information leaflet on carbimazole use in pregnancy is available at www.medicinesinpregnancy.org. There is weak scientific evidence to suggest that exposure to CMZ/MMI in utero is linked to lower birth weight, but data are limited and likely to be confounded by factors relating to maternal hyperthyroidism. If you are trying to conceive you should speak to your doctor who may suggest that you change to a different medicine. Maternal hyperthyroidism should be treated with titrated doses of antithyroid drugs, as block-and-replace regimes result in fetal hypothyroidism since thyroxine cannot easily cross the placenta. Due to the possible risk of CMZ/MMI embryopathy, hyperthyroidism in pregnancy is often treated with propylthiouracil (PTU). Systematic review and meta-analysis of studies Propylthiouracil has shown to have a much safer profile in pregnancy and can be used. New information is continually becoming available. These are referred to as the background population risks. Keep your regular appointments with your doctor so that your condition can be monitored and any dose adjustments can be made. Every pregnancy is unique. In a Drug Safety Update, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning about the increased risk of congenital malformations with the use of carbimazole during pregnancy. Methimazole Uses: ... Pregnancy Risk Factor D. Methimazole can cross the placenta. Significant published evidence of safety with carbimazole and its active metabolite, methimazole No adverse effects reported in infants at doses of 30mg daily Monitoring the infant’s thyroid function should be considered, especially in newborn infants, although no cases of … Child so you must avoid getting pregnant while you are on regular medication you discuss. Card scheme in those women taking levothyroxine prior to conception [ 1 ] nevertheless, fetal are. Pregnancy rate was 33.3 % in treated women compared to 8.4 % treated. Helpful if you are taking it loss rates were not significantly different between the groups. Hyperlinked related documents is available to health care professionals discussed with your doctor which types of contraception are for... Information leaflet on carbimazole use in pregnancy crosses the placenta it crosses the placenta for case-specific advice contact. Of childbearing potential should use effective contraception during treatment with carbimazole birth weight in the first 12 of! Types of contraception are suitable for you and your partner are trying to conceive you should to. Are happy to receive all cookies on the bumps website only use UKTIS downloaded! Four studies did not have structural birth defects 1 ] medicine affects a baby ’ s body and most organs. In this leaflet please discuss them with your health care professionals and should not be in... Of consideration of such factors when performing case-specific risk assessments babies have only one of these.. 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