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Gideon Koren - One of the best experts on this subject based on the ideXlab platform.
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THERAPY
2016Co-Authors: Anna Taddio, Julia Klein, Gideon KorenAbstract:infants. Breast milk samples were also collected three to five days after the last maternal dose and ranged from 0.09 to 0.22 umol/L, These limited sampling times did not al-low any pharmacokinetic analyses.' Although we also report the excretion of acyclovir in breast milk, the maternal dosage used was higher than in previous reports. Results Acyclovir concentrations in breast milk ranged from 18.5 umol (4.16!lg/mL) to 25.8 umol (5.81!lglmL) (Table 1). The highest acyclovir concentration observed was almost 10 hours after a maternal dose, and the lowest level ob-served was 1 hour after maternal dosing. The mother noted no adverse effects in the infant during her therapy. CASE REPORT A gravida I, para I woman, aged 28 y, called the Motherisk Pr0-gram (an antenatal-perinatal information counseling service lo-cated at The Hospital for Sick Children in Toronto) regarding the safety of using acyclovir while nursing. Her infant was aged 7 mo and was fed exclusively breast milk. The acyclovir was pre-scribed for herpes zoster and an 800-mg dose was administered five times daily for seven days. After consulting with Motherisk, the mother decided to continue nursing the child and agreed to collect milk samples for acyclovir analysis. The patient was told to watch for any changes in the infant during acyclovir therapy; however, she was not provided with a list of signs and symptoms of acyclovir adverse effects. The patient tried to adhere to pre-scribed dosing times of 0700, 1100, 1500, 1900, and 2300 h as much as possible. Three milk samples were collected by the pa-tient at her own convenience. All samples were taken at steady-state (on the fifth and sixth days of therapy). In addition to the acyclovir, she also used acetaminophen-codeine 30 mg on an as-needed basis for the first three days of acyclovir therapy to de-crease pain. The samples were centrifuged and 1O-IIL aliquots were taken from the supernatant for radioimmunoassay (RIA). After the samples were diluted lOO-fold by using the RIA buffer, they were analyzed in the laboratory of our hospital, using a previous-ly described method,"
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Rates of Fetal Polydrug Exposures in Methadone- Maintained Pregnancies from a High-Risk Population
2016Co-Authors: Kaitlyn Delano, Joey Gareri, Gideon KorenAbstract:Methadone maintenance treatment (MMT) is the standard of care during pregnancy for opioid-dependency, showing efficacy in improving prenatal care and reducing risk of relapse. By design, however, MMT is only intended to prevent withdrawal thus facilitating cognitive behavioural interventions. In order to maximize the benefits of MMT, it is essential that methadone is both properly prescribed and that additional addiction treatment is concurrently administered. This study aims to determine the effectiveness of MMT engagement in high-risk pregnant women in reducing polydrug use by objective laboratory examination of neonatal meconium. Patients and Methods: Over a 29-month period, the Motherisk Laboratory at the Hospital for Sick Children in Toronto analyzed meconium samples as per request by social services and hospitals for drugs of abuse. Results: Of the 904 meconium samples received, 273 were tested for methadone with 164 positive and 109 negative for methadone. Almost half of the methadone positive samples (46.34%) were also positive for at least one other opioid compound, which did not differ statistically from the methadone-negative control samples (46.79%; Chi square test, p=0.94). No differences were found between the methadone positive and negative groups in rates of concurrent amphetamines, cocaine, cannabis, and alcohol use indicating a similar risk of polydrug use between pregnant women taking or not taking methadone in this population
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Hair Mercury Levels of Women of Reproductive Age in Ontario, Canada: Implications to Fetal Safety and Fish Consumption
2015Co-Authors: Gideon KorenAbstract:roductive age in relation to fish intake in e Motherisk Program for information onICP-MS Inductively coupled plasma mass spectrometryC ompared with other types of meat, fish are a source of high-quality lean protein and n-3 polyunsaturated fatty acids, which are essential for growth of the developing fetal brain.1 The predominant drawback of fish consumption for ex-pectant mothers is that all fish contain traces of methyl mercury, a known developmental neurotoxin. Methyl mercury concentration varies widely among fish species. Top predatory fresh-water fish frommercury-contaminated lakes typically con-tain the highest levels.2 Although epidemics in which large numbers of people were affected by high doses of methyl mercury in Japan3 and Iraq4 affirmed the fact that consumption of high concentrations of methyl mercury in foodstuffs by pregnant women can cause severe neurodevelopment problems in offspring,5 the implications of much lower level exposures, such as those occurring in fish-eating populations today, are largely unknown. The threshold that will adversely affect the developing fetus is debated. In January 2001, the US Food and Drug Administration (FDA) and the US Environmental Protection Agency (EPA) issued advisories counselling pregnant women to avoid consuming specified long-lived predatory fish, which may contain high levels of organic mercury, and to limit ingestion of all other fish.6,7 After this advisory was issued, it has been found that many Amer
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comparing pyridoxine and doxylamine succinate pyridoxine hcl for nausea and vomiting of pregnancy a matched controlled cohort study
The Journal of Clinical Pharmacology, 2015Co-Authors: Eliza Pope, Caroline Maltepe, Gideon KorenAbstract:Nausea and vomiting of pregnancy (NVP) is a common gestational condition. This is the first study to compare the use of vitamin B6 (pyridoxine) versus Diclectin (doxylamine succinate-pyridoxine HCl) for NVP symptoms. Participants were pregnant women with NVP who used either pyridoxine or doxylamine succinate-pyridoxine HCl for ≥4 days prior to calling the Motherisk NVP Helpline. Women receiving pyridoxine only (n = 80) were matched to a woman taking doxylamine succinate-pyridoxine HCl only (n = 80), accounting for potential confounders and baseline level of NVP, measured by the Pregnancy Unique Quantification of Emesis (PUQE) score. Change in NVP severity after a week of therapy with either pyridoxine or doxylamine succinate-pyridoxine HCl was quantified using the PUQE-24 scale, which describes NVP symptoms 24 hours prior to their call. Doxylamine succinate-pyridoxine HCl use found a significant reduction in PUQE score, compared with pyridoxine (+0.5 versus -0.2, P < .05; negative denotes worsening). This association was especially prominent in women with more severe symptoms, where doxylamine succinate-pyridoxine HCl use saw a mean improvement of 2.6 versus 0.4 with pyridoxine (P < .05). As well, doxylamine succinate-pyridoxine HCl use was associated with fewer women experiencing moderate to severe scores after a week of treatment, compared with the pyridoxine group (7 versus 17, P < .05), despite similar baseline PUQE scores.
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DRUGS IN PREGNANCY Motherisk ROUNDS Rates of Spontaneous and Therapeutic Abortions Following Use of Antidepressants in Pregnancy: Results From a Large Prospective Database
2015Co-Authors: Adrienne Einarson, Jacqueline Choi, Bsc Thomas, R. Einarson, Gideon KorenAbstract:Objective: The use of antidepressants during pregnancy remains a controversial issue, and there is little information on the risk of spontaneous abortions following antidepressant exposure in early pregnancy. We sought to examine whether use of antidepressants increases the rates of spontaneous abortion (SA) and therapeutic abortion (TA) in women exposed in early pregnancy. Methods: In a cohort of women who contacted the Motherisk program during pregnancy, we compared two groups of women, one exposed and the other not exposed to antidepressants during pregnancy, and calculated the associated rates of SA and TA. Results: Among 937 women exposed to antidepressants prior to and during early pregnancy, there were 122 SAs (13.0%) including three ectopic pregnancies, and in the comparison group there were 75 SAs (8.0%) and no ectopic pregnancies. The relative ris
Adrienne Einarson - One of the best experts on this subject based on the ideXlab platform.
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DRUGS IN PREGNANCY Motherisk ROUNDS Rates of Spontaneous and Therapeutic Abortions Following Use of Antidepressants in Pregnancy: Results From a Large Prospective Database
2015Co-Authors: Adrienne Einarson, Jacqueline Choi, Bsc Thomas, R. Einarson, Gideon KorenAbstract:Objective: The use of antidepressants during pregnancy remains a controversial issue, and there is little information on the risk of spontaneous abortions following antidepressant exposure in early pregnancy. We sought to examine whether use of antidepressants increases the rates of spontaneous abortion (SA) and therapeutic abortion (TA) in women exposed in early pregnancy. Methods: In a cohort of women who contacted the Motherisk program during pregnancy, we compared two groups of women, one exposed and the other not exposed to antidepressants during pregnancy, and calculated the associated rates of SA and TA. Results: Among 937 women exposed to antidepressants prior to and during early pregnancy, there were 122 SAs (13.0%) including three ectopic pregnancies, and in the comparison group there were 75 SAs (8.0%) and no ectopic pregnancies. The relative ris
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essay for the 2011 cihr cmaj award Motherisk caring for mothers protecting the unborn
Canadian Medical Association Journal, 2012Co-Authors: Gideon Koren, Irena Nulman, Adrienne Einarson, Katarina Aleksa, Joey Gareri, Shinya ItoAbstract:See related articles by Kelsall at [www.cmaj.ca/lookup/doi/10.1503/cmaj.112129][1], and by Drucker at [www.cmaj.ca/lookup/doi/10.1503/cmaj.112127][2] Every year, scores of new medications enter the market, and few of them have safety data concerning fetal exposure during pregnancy. With half of all
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perception of teratogenic risk and the rated likelihood of pregnancy termination association with maternal depression
The Canadian Journal of Psychiatry, 2011Co-Authors: Asnat Walfisch, Adrienne Einarson, Corey Sermer, Ilan Matok, Gideon KorenAbstract:Objective:Women are often exposed to various medications and medical conditions during pregnancy. Unrealistically high maternal teratogenic risk perception, related to these exposures, may lead to abrupt discontinuation of therapy and (or) termination of a wanted pregnancy. The association between maternal depression and the teratogenic risk perception has not been studied, nor were the actions resulting from this perception. Our objectives were to explore the association between maternal depression, teratogenic risk perception, and the rated likelihood to terminate pregnancy. Additionally, we evaluated possible benefits of counselling.Methods:We administered the Edinburgh Postnatal Depression Scale (EPDS) to all women who attended the Motherisk Clinic between October 2007 and April 2010. A visual analogue scale was used to determine maternal risk perception in relation to the specific exposure, and the rated likelihood to terminate the pregnancy, before and after counselling.Results:We analyzed data from...
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Motherisk update safety of antihistamines during pregnancy and lactation
2010Co-Authors: Pina Bozzo, Miho Inoue, Adrienne EinarsonAbstract:QUESTION Many of my pregnant and breastfeeding patients suffer from allergies and frequently ask me about the safety of antihistamines during pregnancy and breastfeeding. Should I advise them to use the older sedating medications? I have heard that they might be safer than the newer nonsedating class of drugs. Or have the newer ones been studied as well? ANSWER First-generation antihistamines are considered safe to use during pregnancy . There are relatively fewer data on the nonsedating second-generation antihistamines; however, published studies are reassuring. All antihistamines are considered safe to use during breastfeeding, as minimal amounts are excreted in the breast milk and would not cause any adverse effects on a breastfeeding infant.
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A pilot study of paternal drug exposure: the Motherisk experience.
Reproductive Toxicology, 2010Co-Authors: Candace Y.w. Lee, Adrienne Einarson, Cheng Jin, Andrea M. Mata, Toshihiro Tanaka, Gideon KorenAbstract:Abstract Background There is a dearth of information on paternal drug exposure at the time of conception. The Motherisk Program, established in 1985, is a teratology information and clinical consultation service on drug safety during pregnancy and lactation, as well as paternal exposure (PEx). Here, we reviewed for the first time our experience with PEx. Methods This was an observational retrospective cohort study using a prospectively collected database. Telephone counselling records from January 2002 to December 2007, inclusive, were screened to identify cases concerning PEx. Results Of a total of 188,188 counselling requests over these 6 years, 301 (0.16%) pertained to PEx. Counselling was most frequently sought on methotrexate, finasteride, prednisone and azathioprine. For many drugs, limited or no information was available on PEx. Conclusions Paternal exposure represents a small fraction of counselling requests to Motherisk. Our findings suggest that there is an ongoing need for information on paternal drug exposure.
Koren Gideon - One of the best experts on this subject based on the ideXlab platform.
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How physicians perceive and utilize information from a teratogen information service: The Motherisk Program
2018Co-Authors: Einarson Adrienne, Park Andrew, Koren GideonAbstract:Abstract Background Teratogen information services have been developed around the world to disseminate information regarding the safety of maternal exposures during pregnancy. The Motherisk Program in Toronto, Canada, fields thousands of these inquiries per year. Our primary objective was to evaluate the perception and utilization of information received from us by physicians. Our secondary objective was to examine their information seeking behavior, in particular regarding teratogen information. Methods A one page survey was sent to physicians who had called Motherisk for information concerning pregnancy exposures in the previous 30 days for three months. Among the questions that were asked were demographics, which included gender, years in practice, specialty, information resources, and how they utilized the information received from Motherisk. Results We received 118/200 completed questionnaires (59% response rate). The mean age of the respondents was: 42 ± 9 years, mean years of practice was: 14 ± 8 years, males: 46(38%) and females 72(62%) and 95(80%) were family physicians. 56(48%) researched their question prior to calling Motherisk, 106(91%) and passed on the information received to their patient verbatim. The top four resources for information were: 1) The CPS (PDR), 2) textbooks, 3) journals and 4) colleagues. Only 8% used the Medline for gathering information. Conclusions Physicians feel that a teratogen information service is an important component in the management of women exposed to drugs, chemicals, radiation and infections diseases etc. during pregnancy. Despite the advent of the electronic age, a minority of the physicians in our survey elected to use electronic means to seek information
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Rates of Fetal Polydrug Exposures in Methadone-Maintained Pregnancies from a High-Risk Population
Public Library of Science, 2013Co-Authors: Delano Kaitlyn, Gareri Joey, Koren GideonAbstract:Over a 29-month period, the Motherisk Laboratory at the Hospital for Sick Children in Toronto analyzed meconium samples as per request by social services and hospitals for drugs of abuse.Of the 904 meconium samples received, 273 were tested for methadone with 164 positive and 109 negative for methadone. Almost half of the methadone positive samples (46.34%) were also positive for at least one other opioid compound, which did not differ statistically from the methadone-negative control samples (46.79%; Chi square test, p=0.94). No differences were found between the methadone positive and negative groups in rates of concurrent amphetamines, cocaine, cannabis, and alcohol use indicating a similar risk of polydrug use between pregnant women taking or not taking methadone in this population. The high rates of additional opioid and other drug use in the MMT group, suggest that MMT is failing this population of patients. It is possible that methadone doses during pregnancy are not appropriately adjusted for changes in pharmacokinetic parameters (e.g. blood volume, renal function) during the second and third trimesters. This may result in sub-therapeutic dosing creating withdrawal symptoms leading to additional substance use. Alternatively, these results may be demonstrating a substantial lack in delivery of addiction support services in this vulnerable population
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Nausea and vomiting of pregnancy (NVP) and depression: cause or effect?
'Canadian Society for Clinical Investigation', 2011Co-Authors: Bozzo Pina, Koren Gideon, Einarson, Thomas R, Einarson AdrienneAbstract:Background: Both nausea and vomiting and depression are common conditions affecting women during pregnancy. Several studies have linked depression with nausea and vomiting of pregnancy (NVP); however, researchers were unable to determine whether depression was caused by NVP or by a pre-existing condition. Objective: To determine whether NVP is associated with depression in women with no history of depression prior to pregnancy. Study design and methods: This was a prospective, observational, longitudinal study. Women with no diagnosis of depression who contacted The Motherisk Program prior to becoming pregnant or were at < 6 weeks gestation were enrolled in the study. Each woman was interviewed at 8, 11, 18, 30 weeks gestation and at 6-18 weeks post-partum. At each interview, we administered the EDPS, Wellbeing and PUQE questionnaires and analyzed the data for correlation between depression and NVP. Results: Data were analyzed obtained from 57 women. There were five EPDS scores ≥13 (one at baseline and two each at weeks 8 and 11) considered indicative of depression and 11 cases with PUQE scores ≥7, indicative of moderate-high severity of NVP. We did not find an association between high PUQE scores and high EPDS scores and conversely, there was no relationship between high EPDS scores and high PUQE scores. Conclusion: No association between depressive symptoms and NVP was observed; however, our sample size was very small and further studies could be done with a larger population of pregnant women
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Metformin use during the first trimester of pregnancy: Is it safe?
College of Family Physicians of Canada, 2006Co-Authors: Koren Gideon, Gilbert Cameron, Valois MariaAbstract:QUESTION: A pregnant patient with polycystic ovary syndrome asked me whether continuing metformin, which she was taking to treat infertility before her pregnancy, is safe for her fetus. She has heard that metformin is a “drug for diabetes.” How safe is it to take metformin during the first trimester of pregnancy and beyond? ANSWER: Despite the traditional response that all oral hypoglycemic agents are absolutely contraindicated during pregnancy,1-3 evidence that metformin is probably safe during the first trimester of pregnancy and beyond is accumulating. Results of a recent meta-analysis by the Motherisk Program showed no increase in incidence of major malformations and a potential protective effect in this patient population
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Screening for fetal alcohol spectrum disorder
College of Family Physicians of Canada, 2005Co-Authors: Gareri Joey, Chan Daphne, Klein Julia, Koren GideonAbstract:QUESTION: I have several patients whom I suspect are drinking during pregnancy. How can I find out for sure if they are? ANSWER: You can use one of the validated tools to screen for problem drinking. Motherisk uses the TWEAK test, but others are just as good. Following birth, you can test infants’ meconium for metabolites of ethanol to detect whether they were exposed in utero to excessive drinking
Irena Nulman - One of the best experts on this subject based on the ideXlab platform.
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validation of the facial photographic in fetal alcohol spectrum disorder screening and diagnosis
The Canadian journal of clinical pharmacology, 2014Co-Authors: Marina Avner, Gideon Koren, Paul Henning, Irena NulmanAbstract:Objective To validate the computer-assisted method of measuring palpebral fissure length and philtrum smoothness using digital patient photographs. These are key diagnostic facial features of Fetal Alcohol Syndrome. Design Prospective study. Setting Motherisk Program (including Breaking the Cycle), Hospital for Sick Children, Toronto - a clinical, research and teaching program dedicated to antenatal drug, chemical, and disease risk counseling. Participants 40 children referred for FASD assessment, 21 under 4 years old, 19 were 4 years or older. Interventions Facial measurements were obtained directly from the patient by physicians and compared to those obtained by computer software measurement of photographs of the same patient.
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towards identifying a characteristic neuropsychological profile for fetal alcohol spectrum disorders 1 analysis of the Motherisk fasd clinic
Journal de la thérapeutique des populations et de la pharamcologie clinique, 2013Co-Authors: Kelly Nash, Irena Nulman, Sara A Stevens, Joanne Rovet, Ellen Fantus, Donna Sorbara, Gideon KorenAbstract:Objective Children with FASD display a heterogeneous profile and may have deficits in physical, behavioural, emotional, and social functioning, as the result of prenatal alcohol exposure. The major objective of the current study was to identify if a specific pattern of neuropsychological functioning exists among children prenatally exposed to alcohol who received a diagnosis, versus exposed children who did not. We compared groups on domains of intellectual functioning, memory, attention, executive functioning, motor functioning, language/communication and achievement. Methods One hundred and seventy children who were seen in the clinic between 2005 and 2009 were included in this study. Out of the total 170 children seen, 109 received an FASD diagnosis. Results We identified a specific neuropsychological profile that typifies children diagnosed with an FASD versus those exposed prenatally to alcohol, who did not receive a diagnosis. Diagnosed children displayed a neuropsychological profile characterized by weaknesses in the areas of verbal reasoning, memory, overall language functioning, math reasoning and calculation. Groups did not differ on measures of attention or executive functioning. Conclusion The information gained from these analyses, are essential for informing best practices for diagnosis and treatment.
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essay for the 2011 cihr cmaj award Motherisk caring for mothers protecting the unborn
Canadian Medical Association Journal, 2012Co-Authors: Gideon Koren, Irena Nulman, Adrienne Einarson, Katarina Aleksa, Joey Gareri, Shinya ItoAbstract:See related articles by Kelsall at [www.cmaj.ca/lookup/doi/10.1503/cmaj.112129][1], and by Drucker at [www.cmaj.ca/lookup/doi/10.1503/cmaj.112127][2] Every year, scores of new medications enter the market, and few of them have safety data concerning fetal exposure during pregnancy. With half of all
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guidelines for maternal codeine use during breastfeeding
Canadian Family Physician, 2009Co-Authors: Parvaz Madadi, Pina Bozzo, Irena Nulman, Nada Djokanovic, Myla E. Moretti, Gideon KorenAbstract:QUESTION In light of the recent evidence of adverse events in infants whose mothers use codeine medication, we have been struggling with the issue of how to manage codeine analgesia in our postpartum patients. What are some guidelines for the safe use of codeine during breastfeeding? ANSWER Motherisk has summarized recent scientific evidence into suggested guidelines for the safe use of codeine during breastfeeding.
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guidelines for maternal codeine use during breastfeeding
Canadian Family Physician, 2009Co-Authors: Parvaz Madadi, Pina Bozzo, Irena Nulman, Nada Djokanovic, Myla E. Moretti, Gideon KorenAbstract:QUESTION In light of the recent evidence of adverse events in infants whose mothers use codeine medication, we have been struggling with the issue of how to manage codeine analgesia in our postpartum patients. What are some guidelines for the safe use of codeine during breastfeeding? ANSWER Motherisk has summarized recent scientific evidence into suggested guidelines for the safe use of codeine during breastfeeding.
Shinya Ito - One of the best experts on this subject based on the ideXlab platform.
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essay for the 2011 cihr cmaj award Motherisk caring for mothers protecting the unborn
Canadian Medical Association Journal, 2012Co-Authors: Gideon Koren, Irena Nulman, Adrienne Einarson, Katarina Aleksa, Joey Gareri, Shinya ItoAbstract:See related articles by Kelsall at [www.cmaj.ca/lookup/doi/10.1503/cmaj.112129][1], and by Drucker at [www.cmaj.ca/lookup/doi/10.1503/cmaj.112127][2] Every year, scores of new medications enter the market, and few of them have safety data concerning fetal exposure during pregnancy. With half of all
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Motherisk update hyperthyroidism during pregnancy
2009Co-Authors: Miho Inoue, Gideon Koren, Frcpc Facmt, Naoko Arata, Shinya ItoAbstract:QUESTION I have a 33-year-old patient with hyperthyroidism who is 6 weeks pregnant. Her thyroid function is well controlled with a 5-mg dose of methimazole 3 times daily. She was initially treated with propylthiouracil but was switched to methimazole owing to urticaria. I have heard about birth defects in infants whose mothers used methimazole during pregnancy. How safe is it? ANSWER In North America, propylthiouracil has been the drug of choice for hyperthyroidism during pregnancy. Methimazole is widely used in Europe, South America, and Asia, and is an alternative for patients who cannot tolerate propylthiouracil. Some case reports raised concern about fetal toxicity from methimazole, which is reportedly characterized by aplasia cutis, esophageal atresia, choanal atresia, facial abnormalities, and mental retardation. However, causality is unclear and the overall risk of congenital abnormalities in infants exposed to methimazole in utero was not higher than in those exposed to nonteratogenic drugs in cohort studies. It is important for a pregnant woman to continue methimazole, if necessary, because uncontrolled hyperthyroidism increases the risk of complications such as preterm labour and low birth weight.
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Motherisk update guidelines for maternal codeine use during breastfeeding
2009Co-Authors: Parvaz Madadi, Pina Bozzo, Nada Djokanovic, Myla E. Moretti, Shinya Ito, Gideon KorenAbstract:QUESTION In light of the recent evidence of adverse events in infants whose mothers use codeine medication, we have been struggling with the issue of how to manage codeine analgesia in our postpartum patients. What are some guidelines for the safe use of codeine during breastfeeding? ANSWER Motherisk has summarized recent scientific evidence into suggested guidelines for the safe use of codeine during breastfeeding. RESUME QUESTION Compte tenu des recentes donnees scientifiques sur les evenements indesirables survenus chez des nourrissons dont les meres prenaient des medicame nts avec codeine, nous nous demandons comment proceder en ce qui a trait a l'administration postpartum d'analgesiques avec codeine a nos patientes. Existe-t-il des directives sur l'utilisation sans danger de la codeine pendant l'allaitement? REPONSE Motherisk a resume les donnees scientifiques recentes sous forme de lignes directrices proposees pour l'utilisation securitaire de la codeine durant l'allaite ment.
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perinatal outcome following third trimester exposure to paroxetine
JAMA Pediatrics, 2002Co-Authors: Adriana Moldovan Costei, Eran Kozer, Shinya Ito, Gideon KorenAbstract:Background Paroxetine hydrochloride is commonly used for maternal depression, panic disorder, and obsessive-compulsive disorder. The drug readily crosses the human placenta. Although it does not appear to increase teratogenic risk, there have been case reports of neonatal withdrawal. Symptoms were described soon after birth and lasted up to 1 month. Objective To investigate whether there is a clinically important discontinuation syndrome in neonates exposed to paroxetine in utero. Methods Prospective, controlled cohort study. Patients Fifty-five pregnant women counseled prospectively by the Motherisk program in Toronto, Ontario, regarding third-trimester exposure to paroxetine and their infants were included in the study group. Pregnant women who discontinued paroxetine before the third trimester or those receiving other drugs known to cause withdrawal-type symptoms, such as opioids or benzodiazepines, were excluded. A comparison group of 27 women using paroxetine during the first or second trimester and 27 women using nonteratogenic drugs were matched for maternal age, gravity, parity, social drug use, and nonteratogenic drug use. Results Of the 55 neonates exposed to paroxetine in late gestation, 12 had complications necessitating intensive treatment and prolonged hospitalization. The most prevalent clinical picture was respiratory distress (n = 9), followed by hypoglycemia (n = 2), and jaundice (n = 1). The symptoms disappeared within 1 to 2 weeks. In the comparison group, only 3 infants experienced complications (P= .03). In logistic regression, only third-trimester exposure to paroxetine was associated with neonatal distress (odds ratio, 9.53; 95% confidence interval, 1.14-79.3). Conclusion When used near term, paroxetine is associated with a high rate of neonatal complications, possibly caused by its common discontinuation syndrome.