Migraine is a common disorder among women of childbearing age. Triptan medications are effective ... more Migraine is a common disorder among women of childbearing age. Triptan medications are effective and commonly used to treat migraines in pregnancy. However, the reproductive safety of this group of drugs has not yet been confirmed. The aim of this study was to determine the reproductive safety of triptan medications by performing a literature review and a meta-analysis. Available publications regarding pregnancy outcomes following prenatal exposure to triptans from 1991 to 2013 were identified and reviewed according to the inclusion criteria. A random-effects meta-analysis model was implemented to combine the available pregnancy outcome data for the exposed and comparison groups. One case-control study and 5 cohort studies met the inclusion criteria. The included studies provided information on duration of gestation, major congenital malformations, and spontaneous abortions of infants following prenatal triptan exposure. The 6 studies included 4208 infants of women who used sumatriptan or other triptan medications, and 1,466,994 children of women who did not use triptans during pregnancy. No significant increases in rates for major congenital malformations (MCMs), prematurity, or spontaneous abortions were found when comparing the triptan-exposed group to the migraine - no triptans control group (odds ratio [OR] = 0.84 [0.61-1.16]; OR = 0.90 [0.35-2.30]; OR = 1.27 [0.58-2.79], respectively). There were no increased rate of MCMs (OR = 1.18 [0.97-1.44]) or prematurity (OR = 1.16 (0.67-1.99) when the triptan-exposed group was compared with the healthy controls; however, there was a significant increase in the rates of spontaneous abortions (OR = 3.54 [2.24-5.59]). When the migraine no-triptan group was compared with healthy controls, a significant increase in the rates of MCMs was found (OR = 1.41 [1.11-1.80]). The use of triptans during pregnancy does not appear to increase the rates for MCMs or prematurity. The increased rates of spontaneous abortions in the triptan-exposed group and the increased rates of MCM in the migraine no-triptan group require further research.
Lamotrigine is used in pregnancy to control epilepsy and mood disorders. The reproductive safety ... more Lamotrigine is used in pregnancy to control epilepsy and mood disorders. The reproductive safety of this widely used drug remains undefined and may represent a significant public health concern. We aimed to perform a systematic review and meta-analysis of existing knowledge related to malformation rates and maternal-neonatal outcomes after in utero exposure to monotherapy with lamotrigine. Relevant studies were identified through systematic searches conducted in MEDLINE (Ovid), Embase (Ovid), CENTRAL (Ovid), and Web of Science (Thomson Reuters) from database inception to July 2016; no language or date restrictions were applied. All publications of clinically relevant outcomes of pregnancies following in utero exposure to lamotrigine were included in this systematic review and meta-analysis. A total of 21 studies describing immediate pregnancy outcomes and rates of congenital malformations fulfilled the inclusion criteria. Compared with disease-matched controls (n = 1412, total number of patients) and healthy controls (n = 774,571, total number of patients), in utero exposure to lamotrigine monotherapy was found to be associated with significantly decreased rates of inborn defects (odds ratio [OR] 1.15; 95% confidence interval [CI] 0.62-2.16 and OR 1.25; 95% CI 0.89-1.74, respectively). Rates of miscarriages, stillbirths, preterm deliveries, and small for gestational age (SGA) neonates were not found to have been increased after in-utero exposure to LTG compared to the general population. Similarly, in utero exposure to lamotrigine monotherapy was not found to be associated with increased rates of inborn defects compared with in utero exposure to carbamazepine, and lamotrigine was found to be statistically significantly less teratogenic than valproic acid (n = 12,958 and 10,748; OR 0.84; 95% CI 0.68-1.03 and OR 0.32; 95% CI 0.26-0.39, respectively). No association was found between prenatal lamotrigine monotherapy and increased rates of birth defects and other explored variables related to adverse pregnancy outcomes.
Journal of Obstetrics and Gynaecology Canada Jogc Journal D Obstetrique Et Gynecologie Du Canada Jogc, Aug 1, 2010
Objective: to establish national standards of care for the screening and recording of alcohol use... more Objective: to establish national standards of care for the screening and recording of alcohol use and counselling on alcohol use of women of child-bearing age and pregnant women based on the most up-to-date evidence. Evidence: published literature was retrieved through searches of PubMed, CINAHL, and the Cochrane Library in May 2009 using appropriate controlled vocabulary (e.g., pregnancy complications, alcohol drinking, prenatal care) and key words (e.g., pregnancy, alcohol consumption, risk reduction). Results were restricted to literature published in the last five years with the following research designs: systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment (HTA) and HTA-related agencies, national and international medical specialty societies, clinical practice guideline collections, and clinical trial registries. Each article was screened for relevance and the full text acquired if determined to be relevant. The evidence obtained was reviewed and evaluated by the members of the Expert Workgroup established by the Society of Obstetricians and Gynaecologists of Canada. The quality of evidence was evaluated and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care. Values: the quality of evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table 1). Sponsor: the Public Health Agency of Canada and the Society of Obstetricians and Gynaecologists of Canada. Endorsement: these consensus guidelines have been endorsed by the Association of Obstetricians and Gynecologists of Quebec; the Canadian Association of Midwives; the Canadian Association of Perinatal, Women's Health and Neonatal Nurses (CAPWHN); the College of Family Physicians of Canada; the Federation of Medical Women of Canada; the Society of Rural Physicians of Canada; and Motherisk. SUMMARY STATEMENTS: 1. There is evidence that alcohol consumption in pregnancy can cause fetal harm. (II-2) There is insufficient evidence regarding fetal safety or harm at low levels of alcohol consumption in pregnancy. (III) 2. There is insufficient evidence to define any threshold for low-level drinking in pregnancy. (III) 3. Abstinence is the prudent choice for a woman who is or might become pregnant. (III) 4. Intensive culture-, gender-, and family-appropriate interventions need to be available and accessible for women with problematic drinking and/or alcohol dependence. (II-2). Recommendations: 1. Universal screening for alcohol consumption should be done periodically for all pregnant women and women of child-bearing age. Ideally, at-risk drinking could be identified before pregnancy, allowing for change. (II-2B) 2. Health care providers should create a safe environment for women to report alcohol consumption. (III-A) 3. The public should be informed that alcohol screening and support for women at risk is part of routine women's health care. (III-A) 4. Health care providers should be aware of the risk factors associated with alcohol use in women of reproductive age. (III-B) 5. Brief interventions are effective and should be provided by health care providers for women with at-risk drinking. (II-2B) 6. If a woman continues to use alcohol during pregnancy, harm reduction/treatment strategies should be encouraged. (II-2B) 7. Pregnant women should be given priority access to withdrawal management and treatment. (III-A) 8. Health care providers should advise women that low-level consumption of alcohol in early pregnancy is not an indication for termination of pregnancy. (II-2A).
Journal of Obstetrics and Gynaecology Canada Jogc Journal D Obstetrique Et Gynecologie Du Canada Jogc, Mar 1, 2013
To promote careful education, administration, monitoring and restricted distribution when prescri... more To promote careful education, administration, monitoring and restricted distribution when prescribing and dispensing chemotherapeutic and potentially teratogenic medications, as well as to develop clinical recommendations for the use of cancer chemotherapy in pregnant women and women of child-bearing age. To ensure that women of child-bearing age receiving chemotherapy can be appropriately counselled on the risks of becoming pregnant during treatment, and to provide guidance for health care practitioners treating pregnant women with antineoplastic agents. Published literature was retrieved through searches of PubMed or Medline, CINAHL, and The Cochrane Library in 2011, using appropriate controlled vocabulary (e.g., antineoplastic agents, neoplasms, pregnancy) and key words (e.g., cancer, neoplasms, pregnancy, chemotherapy, antineoplastic agents). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Studies were restricted to those with available English abstracts or text. Searches were updated on a regular basis and incorporated in the guideline to October 2011. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and from national and international medical specialty societies. The quality of evidence is rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). This guideline highlights the need to prevent pregnancy in women who are being treated for cancer and informs health care professionals treating pregnant women with chemotherapy of the potential risks of the therapy or ameliorated treatment protocols. Summary Statements and Recommendations Summary Statements 1. As women are postponing child-bearing, more of them are experiencing cancer in pregnancy. (II-2) 2. Chemotherapeutic agents used to combat cancer cross the placenta and may adversely affect embryogenesis by affecting cell division. (II-1) 3. Exposure to such agents after the first trimester of pregnancy has not been associated with increased risk of malformations but is associated with increased risk of stillbirth, intrauterine growth restriction, and fetal toxicities. (II-2) Recommendations 1. The health care provider should examine the patient's risk of pregnancy and desire to prevent pregnancy during chemotherapy. (I-A) 2. Decisions about the best course of management in pregnancy, including timing of delivery, should balance maternal and fetal risks. Most authorities concur that maternal health and well-being must prevail. (I-A) 3. Women diagnosed with cancer in pregnancy should be optimally managed by a multidisciplinary team that includes oncologists and/or hematologists (depending on the malignancy), perinatologists, family physicians, psychologists, social workers, and spiritual advisors, if sought by the family. (I-A).
Methylphenidate is a central nervous system stimulant medicinally used in the treatment of attent... more Methylphenidate is a central nervous system stimulant medicinally used in the treatment of attention-deficit disorder with or without hyperactivity (ADD/ADHD). Data on its use in human pregnancy are limited. The primary objective of the study was to evaluate the risk of major congenital anomalies after pregnancy exposure to methylphenidate for medical indications. In a prospective, comparative, multicenter observational study performed in 4 participating Teratology Information Services (in Jerusalem, Berlin, Newcastle upon Tyne, and Toronto) between 1996 and 2013, methylphenidate-exposed pregnancies were compared with pregnancies counseled for nonteratogenic exposure (NTE) after matching by maternal age, gestational age, and year at initial contact. 382 methylphenidate-exposed pregnancies (89.5% in the first trimester) were followed up. The overall rate of major congenital anomalies was similar between the groups (10/309 = 3.2% [methylphenidate] vs 13/358 = 3.6% [NTE], P = .780). Th...
The Canadian Journal of Clinical Pharmacology Journal Canadien De Pharmacologie Clinique, Feb 1, 2007
Background: Alcohol is the most prevalent human teratogen affected by early exposure of the fetus... more Background: Alcohol is the most prevalent human teratogen affected by early exposure of the fetus. Although not listed as a major part of the fetal alcohol spectrum disorder (FASD), different texts list hearing loss as a characteristic of the FASD, based on several small studies. Objective: To characterize hearing in children with FASD, diagnosed in the Motherisk Program in Toronto. Design: Cross sectional cohort study. Setting: Academic referral center. Patients: Children 4-16 years of age that met criteria for FASD, with no other known risk factor for sensorineural hearing loss. A consecutive sample of 41 children (13 girls, mean age 8.9 +/-3 years) was collected. Intervention: Physical examination, audiometry and tympanometry. Outcome measures: External and middle ear pathology on physical examination, pure tone average (PTA), speech reception threshold (SRT), discrimination and tympanometry. Results were compared to reference values in the normal population. Hearing loss equal or greater than 16dB hearing-level in each frequency tested was considered to be clinically significant. Results: A total of 5 (11.2%) of children had hearing loss of at least 16dB hearing-level, mostly unilateral. SRT was within the normal range in 40 (98%) of children with FASD and discrimination was normal in all children. None had auricular or external canal dysmorphology. 14.7% of the children had frequent episodes of acute otitis media. Middle ear effusion was detected in 8 ears (9.8%). Conclusions: The prevalence of mild sensorineural hearing loss in children diagnosed with FASD (16dB hearing-level or greater) was not higher than expected in this age group. However, because children with FASD are academically and behaviorally challenged, early detection of hearing loss and early intervention is warranted.
Journal of Obstetrics and Gynaecology Canada Jogc Journal D Obstetrique Et Gynecologie Du Canada Jogc, Feb 1, 2006
Significant numbers of therapeutic abortions are performed for radiation-exposed pregnant women b... more Significant numbers of therapeutic abortions are performed for radiation-exposed pregnant women because of concerns about the teratogenic risk. However, available data suggest that current diagnostic radiation procedures are not teratogenic.
Journal of Population Therapeutics and Clinical Pharmacology Journal De La Therapeutique Des Populations Et De La Pharamcologie Clinique, 2012
Background: Children with fetal alcohol spectrum disorders (FASD) show impairments in social func... more Background: Children with fetal alcohol spectrum disorders (FASD) show impairments in social functioning. However, the factors underlying these impairments are poorly understood. Recent evidence has shown that social problem solving is a critical component of effective social functioning. Objectives: The present study sought to examine social information processing as one potential factor contributing to social skills and behavior impairments observed in children with FASD. Methods: Forty-three children, 20 with FASD (mean age 12.6 years) and 23 typically developing controls (TDC; mean age 12.5 years) were studied. Social information processing was investigated using the Children's Interpersonal Problem Solving task (ChIPS; Shure and Spivack, 1985), which assesses problem solving in response to social dilemmas. Results: Children with FASD produced fewer relevant responses than TDC and their responses belonged to a fewer number of categories. Conclusion: Children with FASD show reduced ability in generating solutions for social dilemmas. By understanding this weakness, which may partially explain the social skill deficiencies in FASD, targeted therapies may be designed to improve social functioning following prenatal alcohol exposure.
Background: Cyclosporine and azathioprine are the most commonly used drugs to prevent rejection o... more Background: Cyclosporine and azathioprine are the most commonly used drugs to prevent rejection of transplanted organs. Pregnancy following renal transplantation can be associated with risks for both the mother and the fetus, therefore it is essential to study the reproductive safety of these drugs.Objectives: To evaluate the prenatal effects of cyclosporine and azathioprine on children's neurodevelopment following maternal renal transplant,
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Jan 30, 2015
The incidence of hematologic malignancies during pregnancy is 0.02%. However, this figure is incr... more The incidence of hematologic malignancies during pregnancy is 0.02%. However, this figure is increasing, as women delay conception until a later age. Systemic symptoms attributed to the development of a hematologic cancer may overlap with physiologic changes of pregnancy. A favorable prognosis is contingent upon early diagnosis and treatment. Therefore, a high index of suspicion is required by health care providers. Although timely, accurate diagnosis followed by appropriate staging is essential and should not be delayed due to pregnancy, management guidelines are lacking due to insufficient evidence-based research. Consequently, treatment is delayed, posing significant risks to maternal and fetal health, and potential pregnancy termination. This report provides guidelines for clinical management of hematologic cancers during the perinatal period, which were developed by a multidisciplinary team including an experienced hematologist/oncologist, a high-risk obstetrics specialist, a n...
Migraine is a common disorder among women of childbearing age. Triptan medications are effective ... more Migraine is a common disorder among women of childbearing age. Triptan medications are effective and commonly used to treat migraines in pregnancy. However, the reproductive safety of this group of drugs has not yet been confirmed. The aim of this study was to determine the reproductive safety of triptan medications by performing a literature review and a meta-analysis. Available publications regarding pregnancy outcomes following prenatal exposure to triptans from 1991 to 2013 were identified and reviewed according to the inclusion criteria. A random-effects meta-analysis model was implemented to combine the available pregnancy outcome data for the exposed and comparison groups. One case-control study and 5 cohort studies met the inclusion criteria. The included studies provided information on duration of gestation, major congenital malformations, and spontaneous abortions of infants following prenatal triptan exposure. The 6 studies included 4208 infants of women who used sumatriptan or other triptan medications, and 1,466,994 children of women who did not use triptans during pregnancy. No significant increases in rates for major congenital malformations (MCMs), prematurity, or spontaneous abortions were found when comparing the triptan-exposed group to the migraine - no triptans control group (odds ratio [OR] = 0.84 [0.61-1.16]; OR = 0.90 [0.35-2.30]; OR = 1.27 [0.58-2.79], respectively). There were no increased rate of MCMs (OR = 1.18 [0.97-1.44]) or prematurity (OR = 1.16 (0.67-1.99) when the triptan-exposed group was compared with the healthy controls; however, there was a significant increase in the rates of spontaneous abortions (OR = 3.54 [2.24-5.59]). When the migraine no-triptan group was compared with healthy controls, a significant increase in the rates of MCMs was found (OR = 1.41 [1.11-1.80]). The use of triptans during pregnancy does not appear to increase the rates for MCMs or prematurity. The increased rates of spontaneous abortions in the triptan-exposed group and the increased rates of MCM in the migraine no-triptan group require further research.
Lamotrigine is used in pregnancy to control epilepsy and mood disorders. The reproductive safety ... more Lamotrigine is used in pregnancy to control epilepsy and mood disorders. The reproductive safety of this widely used drug remains undefined and may represent a significant public health concern. We aimed to perform a systematic review and meta-analysis of existing knowledge related to malformation rates and maternal-neonatal outcomes after in utero exposure to monotherapy with lamotrigine. Relevant studies were identified through systematic searches conducted in MEDLINE (Ovid), Embase (Ovid), CENTRAL (Ovid), and Web of Science (Thomson Reuters) from database inception to July 2016; no language or date restrictions were applied. All publications of clinically relevant outcomes of pregnancies following in utero exposure to lamotrigine were included in this systematic review and meta-analysis. A total of 21 studies describing immediate pregnancy outcomes and rates of congenital malformations fulfilled the inclusion criteria. Compared with disease-matched controls (n = 1412, total number of patients) and healthy controls (n = 774,571, total number of patients), in utero exposure to lamotrigine monotherapy was found to be associated with significantly decreased rates of inborn defects (odds ratio [OR] 1.15; 95% confidence interval [CI] 0.62-2.16 and OR 1.25; 95% CI 0.89-1.74, respectively). Rates of miscarriages, stillbirths, preterm deliveries, and small for gestational age (SGA) neonates were not found to have been increased after in-utero exposure to LTG compared to the general population. Similarly, in utero exposure to lamotrigine monotherapy was not found to be associated with increased rates of inborn defects compared with in utero exposure to carbamazepine, and lamotrigine was found to be statistically significantly less teratogenic than valproic acid (n = 12,958 and 10,748; OR 0.84; 95% CI 0.68-1.03 and OR 0.32; 95% CI 0.26-0.39, respectively). No association was found between prenatal lamotrigine monotherapy and increased rates of birth defects and other explored variables related to adverse pregnancy outcomes.
Journal of Obstetrics and Gynaecology Canada Jogc Journal D Obstetrique Et Gynecologie Du Canada Jogc, Aug 1, 2010
Objective: to establish national standards of care for the screening and recording of alcohol use... more Objective: to establish national standards of care for the screening and recording of alcohol use and counselling on alcohol use of women of child-bearing age and pregnant women based on the most up-to-date evidence. Evidence: published literature was retrieved through searches of PubMed, CINAHL, and the Cochrane Library in May 2009 using appropriate controlled vocabulary (e.g., pregnancy complications, alcohol drinking, prenatal care) and key words (e.g., pregnancy, alcohol consumption, risk reduction). Results were restricted to literature published in the last five years with the following research designs: systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment (HTA) and HTA-related agencies, national and international medical specialty societies, clinical practice guideline collections, and clinical trial registries. Each article was screened for relevance and the full text acquired if determined to be relevant. The evidence obtained was reviewed and evaluated by the members of the Expert Workgroup established by the Society of Obstetricians and Gynaecologists of Canada. The quality of evidence was evaluated and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care. Values: the quality of evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table 1). Sponsor: the Public Health Agency of Canada and the Society of Obstetricians and Gynaecologists of Canada. Endorsement: these consensus guidelines have been endorsed by the Association of Obstetricians and Gynecologists of Quebec; the Canadian Association of Midwives; the Canadian Association of Perinatal, Women's Health and Neonatal Nurses (CAPWHN); the College of Family Physicians of Canada; the Federation of Medical Women of Canada; the Society of Rural Physicians of Canada; and Motherisk. SUMMARY STATEMENTS: 1. There is evidence that alcohol consumption in pregnancy can cause fetal harm. (II-2) There is insufficient evidence regarding fetal safety or harm at low levels of alcohol consumption in pregnancy. (III) 2. There is insufficient evidence to define any threshold for low-level drinking in pregnancy. (III) 3. Abstinence is the prudent choice for a woman who is or might become pregnant. (III) 4. Intensive culture-, gender-, and family-appropriate interventions need to be available and accessible for women with problematic drinking and/or alcohol dependence. (II-2). Recommendations: 1. Universal screening for alcohol consumption should be done periodically for all pregnant women and women of child-bearing age. Ideally, at-risk drinking could be identified before pregnancy, allowing for change. (II-2B) 2. Health care providers should create a safe environment for women to report alcohol consumption. (III-A) 3. The public should be informed that alcohol screening and support for women at risk is part of routine women's health care. (III-A) 4. Health care providers should be aware of the risk factors associated with alcohol use in women of reproductive age. (III-B) 5. Brief interventions are effective and should be provided by health care providers for women with at-risk drinking. (II-2B) 6. If a woman continues to use alcohol during pregnancy, harm reduction/treatment strategies should be encouraged. (II-2B) 7. Pregnant women should be given priority access to withdrawal management and treatment. (III-A) 8. Health care providers should advise women that low-level consumption of alcohol in early pregnancy is not an indication for termination of pregnancy. (II-2A).
Journal of Obstetrics and Gynaecology Canada Jogc Journal D Obstetrique Et Gynecologie Du Canada Jogc, Mar 1, 2013
To promote careful education, administration, monitoring and restricted distribution when prescri... more To promote careful education, administration, monitoring and restricted distribution when prescribing and dispensing chemotherapeutic and potentially teratogenic medications, as well as to develop clinical recommendations for the use of cancer chemotherapy in pregnant women and women of child-bearing age. To ensure that women of child-bearing age receiving chemotherapy can be appropriately counselled on the risks of becoming pregnant during treatment, and to provide guidance for health care practitioners treating pregnant women with antineoplastic agents. Published literature was retrieved through searches of PubMed or Medline, CINAHL, and The Cochrane Library in 2011, using appropriate controlled vocabulary (e.g., antineoplastic agents, neoplasms, pregnancy) and key words (e.g., cancer, neoplasms, pregnancy, chemotherapy, antineoplastic agents). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Studies were restricted to those with available English abstracts or text. Searches were updated on a regular basis and incorporated in the guideline to October 2011. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and from national and international medical specialty societies. The quality of evidence is rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). This guideline highlights the need to prevent pregnancy in women who are being treated for cancer and informs health care professionals treating pregnant women with chemotherapy of the potential risks of the therapy or ameliorated treatment protocols. Summary Statements and Recommendations Summary Statements 1. As women are postponing child-bearing, more of them are experiencing cancer in pregnancy. (II-2) 2. Chemotherapeutic agents used to combat cancer cross the placenta and may adversely affect embryogenesis by affecting cell division. (II-1) 3. Exposure to such agents after the first trimester of pregnancy has not been associated with increased risk of malformations but is associated with increased risk of stillbirth, intrauterine growth restriction, and fetal toxicities. (II-2) Recommendations 1. The health care provider should examine the patient's risk of pregnancy and desire to prevent pregnancy during chemotherapy. (I-A) 2. Decisions about the best course of management in pregnancy, including timing of delivery, should balance maternal and fetal risks. Most authorities concur that maternal health and well-being must prevail. (I-A) 3. Women diagnosed with cancer in pregnancy should be optimally managed by a multidisciplinary team that includes oncologists and/or hematologists (depending on the malignancy), perinatologists, family physicians, psychologists, social workers, and spiritual advisors, if sought by the family. (I-A).
Methylphenidate is a central nervous system stimulant medicinally used in the treatment of attent... more Methylphenidate is a central nervous system stimulant medicinally used in the treatment of attention-deficit disorder with or without hyperactivity (ADD/ADHD). Data on its use in human pregnancy are limited. The primary objective of the study was to evaluate the risk of major congenital anomalies after pregnancy exposure to methylphenidate for medical indications. In a prospective, comparative, multicenter observational study performed in 4 participating Teratology Information Services (in Jerusalem, Berlin, Newcastle upon Tyne, and Toronto) between 1996 and 2013, methylphenidate-exposed pregnancies were compared with pregnancies counseled for nonteratogenic exposure (NTE) after matching by maternal age, gestational age, and year at initial contact. 382 methylphenidate-exposed pregnancies (89.5% in the first trimester) were followed up. The overall rate of major congenital anomalies was similar between the groups (10/309 = 3.2% [methylphenidate] vs 13/358 = 3.6% [NTE], P = .780). Th...
The Canadian Journal of Clinical Pharmacology Journal Canadien De Pharmacologie Clinique, Feb 1, 2007
Background: Alcohol is the most prevalent human teratogen affected by early exposure of the fetus... more Background: Alcohol is the most prevalent human teratogen affected by early exposure of the fetus. Although not listed as a major part of the fetal alcohol spectrum disorder (FASD), different texts list hearing loss as a characteristic of the FASD, based on several small studies. Objective: To characterize hearing in children with FASD, diagnosed in the Motherisk Program in Toronto. Design: Cross sectional cohort study. Setting: Academic referral center. Patients: Children 4-16 years of age that met criteria for FASD, with no other known risk factor for sensorineural hearing loss. A consecutive sample of 41 children (13 girls, mean age 8.9 +/-3 years) was collected. Intervention: Physical examination, audiometry and tympanometry. Outcome measures: External and middle ear pathology on physical examination, pure tone average (PTA), speech reception threshold (SRT), discrimination and tympanometry. Results were compared to reference values in the normal population. Hearing loss equal or greater than 16dB hearing-level in each frequency tested was considered to be clinically significant. Results: A total of 5 (11.2%) of children had hearing loss of at least 16dB hearing-level, mostly unilateral. SRT was within the normal range in 40 (98%) of children with FASD and discrimination was normal in all children. None had auricular or external canal dysmorphology. 14.7% of the children had frequent episodes of acute otitis media. Middle ear effusion was detected in 8 ears (9.8%). Conclusions: The prevalence of mild sensorineural hearing loss in children diagnosed with FASD (16dB hearing-level or greater) was not higher than expected in this age group. However, because children with FASD are academically and behaviorally challenged, early detection of hearing loss and early intervention is warranted.
Journal of Obstetrics and Gynaecology Canada Jogc Journal D Obstetrique Et Gynecologie Du Canada Jogc, Feb 1, 2006
Significant numbers of therapeutic abortions are performed for radiation-exposed pregnant women b... more Significant numbers of therapeutic abortions are performed for radiation-exposed pregnant women because of concerns about the teratogenic risk. However, available data suggest that current diagnostic radiation procedures are not teratogenic.
Journal of Population Therapeutics and Clinical Pharmacology Journal De La Therapeutique Des Populations Et De La Pharamcologie Clinique, 2012
Background: Children with fetal alcohol spectrum disorders (FASD) show impairments in social func... more Background: Children with fetal alcohol spectrum disorders (FASD) show impairments in social functioning. However, the factors underlying these impairments are poorly understood. Recent evidence has shown that social problem solving is a critical component of effective social functioning. Objectives: The present study sought to examine social information processing as one potential factor contributing to social skills and behavior impairments observed in children with FASD. Methods: Forty-three children, 20 with FASD (mean age 12.6 years) and 23 typically developing controls (TDC; mean age 12.5 years) were studied. Social information processing was investigated using the Children's Interpersonal Problem Solving task (ChIPS; Shure and Spivack, 1985), which assesses problem solving in response to social dilemmas. Results: Children with FASD produced fewer relevant responses than TDC and their responses belonged to a fewer number of categories. Conclusion: Children with FASD show reduced ability in generating solutions for social dilemmas. By understanding this weakness, which may partially explain the social skill deficiencies in FASD, targeted therapies may be designed to improve social functioning following prenatal alcohol exposure.
Background: Cyclosporine and azathioprine are the most commonly used drugs to prevent rejection o... more Background: Cyclosporine and azathioprine are the most commonly used drugs to prevent rejection of transplanted organs. Pregnancy following renal transplantation can be associated with risks for both the mother and the fetus, therefore it is essential to study the reproductive safety of these drugs.Objectives: To evaluate the prenatal effects of cyclosporine and azathioprine on children's neurodevelopment following maternal renal transplant,
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Jan 30, 2015
The incidence of hematologic malignancies during pregnancy is 0.02%. However, this figure is incr... more The incidence of hematologic malignancies during pregnancy is 0.02%. However, this figure is increasing, as women delay conception until a later age. Systemic symptoms attributed to the development of a hematologic cancer may overlap with physiologic changes of pregnancy. A favorable prognosis is contingent upon early diagnosis and treatment. Therefore, a high index of suspicion is required by health care providers. Although timely, accurate diagnosis followed by appropriate staging is essential and should not be delayed due to pregnancy, management guidelines are lacking due to insufficient evidence-based research. Consequently, treatment is delayed, posing significant risks to maternal and fetal health, and potential pregnancy termination. This report provides guidelines for clinical management of hematologic cancers during the perinatal period, which were developed by a multidisciplinary team including an experienced hematologist/oncologist, a high-risk obstetrics specialist, a n...
Uploads
Papers by Irena Nulman