The way women perceive teratogenic risk.
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Abnormalities, Drug-Induced↗
Biomedical subjects
Gideon Koren
Publications and source records attributed to Gideon Koren.
Inactive pharmaceutical ingredients : implications for pregnancy.
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Abnormalities, Drug-Induced↗
Drugs in pregnancy: acknowledging challenges--finding solutions.
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Abnormalities, Drug-Induced↗
Validation of the oral mucositis assessment scale in pediatric cancer.
BACKGROUND: Our objective was to examine the construct validity of the Oral Mucositis Assessment Scale (OMAS) in children receiving doxorubicin chemotherapy. METHODS: Children between 6 and 18 years of age with cancer receiving doxorubicin-containing chemotherapy were included. OMAS was measured on days 7, 10, 14, and 17 after chemotherapy. Other measures of mucositis obtained concurrent with OMAS were the World Health Organization (WHO) mucositis scale and pain visual analogue scale (VAS). We also recorded analgesia administration. RESULTS: Sixteen children were studied for 45 post-chemotherapy cycles and 156 OMAS assessments were performed. OMAS was moderately correlated with WHO scores (r = 0.56; P = 0.0006) whereas correlation with the pain VAS was fair (r = 0.37; P = 0.002). OMAS also had fair correlation with the number of doses of topical analgesia (r = 0.43; P = 0.001) and with the cumulative dose of opioid analgesia (r = 0.38; P = 0.003). CONCLUSIONS: The OMAS is valid for use in mucositis clinical trials for children at least 6 years of age.
Administration, Oral↗
Pharmaceutical agents and pregnancy in urology practice.
Urologic medical conditions are not frequently encountered during pregnancy. Still, urologists often are asked to treat pregnant patients for conditions that require prescriptions. In the generally healthy population of pregnant women, the use of pharmaceutical agents is usually reserved for women who have either infections or necessary surgical procedures. This article addresses the implications for pregnancy of common urologic conditions in generally healthy pregnant women, namely simple urinary tract infections that demand nitrofurantoin and complex urinary tract infections that necessitate fluoroquinolones treatment. It also examines the implications of nonobstetric surgical intervention.
Female↗
Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective.
AIMS: To estimate the population-based incidence rates of pregnancy, spontaneous and elective abortions, and birth defects associated with isotretinoin use, and to determine predictors of pregnancy while on isotretinoin. METHODS: Using the RAMQ (medical and pharmaceutical data), MED-ECHO (hospitalizations) and ISQ (births and deaths) databases for the period 1984-2002, a cohort of 8609 women between 13 and 45 years of age and with a first prescription for isotretinoin (date of entry in the cohort) was identified. Women were eligible if they were insured by RAMQ for their medications at least 12 months before entry in the cohort and until 1 month after the end of their isotretinoin treatment. Pregnancies, spontaneous and elective abortions, and birth defects were identified using procedure codes and medical diagnoses. RESULTS: Of the 8609 women included, 90 became pregnant, an annual incident pregnancy rate during isotretinoin treatment of 32.7 per 1000 person-years of treatment (95% confidence interval 26.6, 40.1). Of the 90 women who became pregnant while on the drug, 76 terminated the pregnancy (84%), three had a spontaneous abortion (3%), two had trauma during delivery resulting in neonatal deaths (2%) and nine had a live birth (10%). Among the live births, only one had a congenital anomaly of the face and neck (11%). Adjusting for potential confounders, predictors of becoming pregnant while on isotretinoin were lower socio-economic level, one or more visits to the doctor or to the emergency department, or one or more hospitalization while on isotretinoin; concomitant isotretinoin and oral contraceptive use had a preventive effect. CONCLUSIONS: This first non-interventional population-based study generated incidence rates of pregnancy while on isotretinoin four times greater than what has been reported in the literature thus far; elective abortion rates were also much higher in our study. This shows the importance of using population-based data for public health purposes.
Abnormalities, Drug-Induced↗
Breast-feeding during maternal use of azathioprine.
OBJECTIVE: To report the clinical outcome of infants whose mothers were taking azathioprine while nursing and to quantify the transfer of 6-mercaptopurine (6-MP), its active metabolite, into breast milk. CASE SUMMARY: We report on a series of 4 patients treated with azathioprine while lactating. Breast milk samples were analyzed for 6-MP in 2 of the mothers. Several milk samples per patient were analyzed; levels of 6-MP were undetectable by high performance liquid chromatography (limit of detection 5 ng/mL). Therefore, the absolute relative infant dose would have been less than 0.09% of the maternal weight-adjusted dose. No adverse effects were encountered in any of the 4 infants. DISCUSSION: A large number of women of reproductive age are treated with azathioprine for a range of chronic conditions that require immunosuppression, such as systemic lupus erythematosus or solid organ transplants. Similar to other antimetabolites, the drug has generally been contraindicated for use during breast-feeding because of the theoretical concern for toxicity in the nursing infant. The available literature in this area is sparse and dated. The data presented here confirm published reports of minimal 6-MP excretion into milk, suggesting that significant systemic adverse effects in the infant are unlikely. CONCLUSIONS: Maternal azathioprine use during lactation does not appear to pose a significant immediate clinical risk to the suckling infant. Continued monitoring and long-term assessment of these infants are warranted.
Adult↗
The effectiveness of Teratology Information Services (TIS).
BACKGROUND: Women and their health care providers have few reliable sources of information regarding the safety of exposures in pregnancy and lactation. Evidence-based information on these topics is provided by Teratology Information Services (TIS). Access to TIS, however, is limited in many regions, and many services have difficulty maintaining ongoing funding. The objective of this review is to highlight published reports of the effectiveness of TIS in improving maternal and neonatal health. METHODS: A search of the Pub Med and Econ Lit databases was performed with no date restriction, using the search terms teratology, information, counseling, pregnancy, effectiveness, birth defects. RESULTS: Information disseminated from TIS has been shown to prevent congenital malformations, unnecessary pregnancy terminations, and occupational risks. TIS support optimal nutritional supplementation in pregnancy and optimal drug therapy in pregnancy and breast-feeding. In addition, they correct misperceptions of risk and facilitate knowledge transfer and translation. TIS have the potential to provide health care cost savings. CONCLUSIONS: TIS are vital services in supporting optimal maternal and neonatal health. A formal economic evaluation of TIS is required in order to inform resource allocation decision-making and continued funding of these services.
Abnormalities, Drug-Induced↗
Safety and efficacy of black cohosh (Cimicifuga racemosa) during pregnancy and lactation.
BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of black cohosh focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: Black cohosh, alone or in combination with other medicinal herbs as "mother's cordial", has a long traditional use and is frequently used by midwives as a uterine stimulant and labour-inducing aid. Low-level evidence based on theory and expert opinion shows the following concerns with respect to black cohosh use during pregnancy: 1) labour-inducing effects, 2) hormonal effects, 3) emmenagogue properties and, 4) anovulatory effects. During lactation, there is low-level evidence from theoretical and expert opinion of black cohosh having hormonal properties. CONCLUSIONS: Black cohosh should be used with caution during pregnancy, particularly during the first trimester where its purported labour-inducing effects could be of concern, and during lactation. Black cohosh should undergo rigorous high quality human studies to determine its safety in pregnancy and lactation.
Cimicifuga↗
Safety and efficacy of echinacea (Echinacea angustafolia, e. purpurea and e. pallida) during pregnancy and lactation.
BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of echinacea focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is good scientific evidence from a prospective cohort study that oral consumption of echinacea during the first trimester does not increase the risk for major malformations. Low-level evidence based on expert opinion shows that oral consumption of echinacea in recommended doses is safe for use during pregnancy and lactation. CONCLUSIONS: Echinacea is non-teratogenic when used during pregnancy. Caution with using Echinacea during lactation until further high quality human studies can determine its safety.
Administration, Oral↗
Safety and efficacy of St. John's wort (hypericum) during pregnancy and lactation.
BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of St. John's wort focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is very weak scientific evidence based on a case report that St Johns wort is of minimal risk when taken during pregnancy. There is in vitro evidence from animal studies that St John's wort during pregnancy does not affect cognitive development nor cause long-term behavioral defects, but may lower offspring birth weight. There is weak scientific evidence that St. John's wort use during lactation does not affect maternal milk production nor affect infant weight, but, in a few cases, may cause colic, drowsiness or lethargy. There is weak scientific evidence that St John's wort induces CYP450 enzymes, which may lower serum medication levels below therapeutic range; this may be of concern when administering medications during pregnancy and lactation. CONCLUSIONS: Caution is warranted with the use of St John's wort during pregnancy until further high quality human research is conducted to determine its safety. St John's wort use during lactation appears to be of minimal risk, but may cause side effects. Caution is warranted when using medications along with St John's wort.
Animals↗
Safety and efficacy of ginkgo (Ginkgo biloba) during pregnancy and lactation.
BACKGROUND: There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. This is one article in a series that systematically reviews the evidence for commonly used herbs during pregnancy and lactation. OBJECTIVES: To systematically review the literature for evidence on the use, safety, and pharmacology of ginkgo focusing on issues pertaining to pregnancy and lactation. METHODS: We searched 7 electronic databases and compiled data according to the grade of evidence found. RESULTS: There is some very weak scientific evidence from animal and in vitro studies that ginkgo leaf has antiplatelet activity, which may be of concern during labour as ginkgo use could prolong bleeding time. Low-level evidence based on expert opinion shows that ginkgo leaf may be an emmenagogue and have hormonal properties. The safety of ginkgo leaf during lactation is unknown. Patients and clinicians should be aware of past reports of ginkgo products being adulterated with colchicine. CONCLUSIONS: Ginkgo should be used with caution during pregnancy, particularly around labour where its anti-platelet properties could prolong bleeding time. During lactation the safety of ginkgo leaf is unknown and should be avoided until high quality human studies are conducted to prove its safety.
Animals↗
The effect of a short tutorial on the incidence of prescribing errors in pediatric emergency care.
BACKGROUND: In the paediatric emergency department (ED) trainees are more likely to commit prescribing errors. OBJECTIVE: To determine whether a short educational intervention reduces the incidence of prescribing errors among trainees in a pediatric ED. METHODS: A prospective cohort study at the ED of a tertiary paediatric hospital. All fellows and residents arriving at the ED at the beginning of the academic year were invited to participate in a 30-minute tutorial focusing on appropriate methods for prescribing medications, followed by a written test. Eighteen days were selected randomly during July 2001. All the charts from these days were reviewed for medication errors. Two reviewers, blinded to whether or not a particular physician attended the tutorial, independently decided whether or not an error had occurred. The main outcome measure was the number of prescribing errors. RESULTS: Twenty-two trainees worked in the ED during July 2001. Of these, 13 trainees attended the tutorial. Eight hundred and ninety nine orders given by trainees were evaluated. We identified 66 (12.4%) errors in 533 orders given by those who attended tutorial, and 46 (12.7%) errors in 363 orders given by those who did not attend tutorial. The adjusted odds of a medication error was not significantly different between those who did not attend the tutorial and those who did (OR: 1.07 95% CI: 0.66-1.70). CONCLUSIONS: A short tutorial, followed by a written test, administered to trainees before entering their rotation in the paediatric ED, did not appear to reduce prescribing errors.
Clinical Competence↗
Health-related quality of life of Canadian children and youth prenatally exposed to alcohol.
BACKGROUND: In Canada, the incidence of Fetal Alcohol Spectrum Disorder (FASD) has been estimated to be 1 in 100 live births. Caused by prenatal exposure to alcohol, FASD is the leading cause of neuro-developmental disabilities among Canadian children, and youth. OBJECTIVE: To measure the health-related quality of life (HRQL) of Canadian children and youth diagnosed with FASD. METHODS: A prospective cross-sectional study design was used. One-hundred and twenty-six (126) children and youth diagnosed with FASD, aged 8 to 21 years, living in urban and rural communities throughout Canada participated in the study. Participants completed the Health Utilities Index Mark 3 (HUI3). HUI3 measures eight health attributes: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Utilities were used to measure a single cardinal value between 0 and 1.0 (0 = all-worst health state; 1 = perfect health) to reflect the global HRQL for that child. Mean HRQL scores and range of scores of children and youth with FASD were calculated. A one-sample t-test was used to compare mean HRQL scores of children and youth with FASD to those from the Canadian population. RESULTS: Mean HRQL score of children and youth with FASD was 0.47 (95% CI: 0.42 to 0.52) as compared to a mean score of 0.93 (95% CI: 0.92 to 0.94) in those from the general Canadian population (p < 0.001). Children demonstrated moderate to severe dysfunction on the single-attributes of cognition and emotion. CONCLUSION: Children and youth with FASD have significantly lower HRQL than children and youth from the general Canadian population. This finding has significant implications for practice, policy development, and research.
Adolescent↗
Comparison of verbal claims for natural health products made by health food stores staff versus pharmacists in Ontario, Canada.
BACKGROUND: This study tested the hypothesis that while there are no written medical claims existing for many NHP, such claims are made verbally, giving a false impression that these are proven medical products. OBJECTIVE: To compare the number and type of verbal claims for NHP made by pharmacists to those made by health food stores personnel. METHODS: Randomly selected Canadian pharmacies selling NHP and health food stores were visited and the staff was asked to recommend natural health products for the treatment of hypertension. RESULTS: All health food stores (n=20) but only 4 out of 38 pharmacies (p< 0.001) recommended NHP for the treatment of hypertension. A majority of health food store staff (70%) stated that NHP are superior or equal to medicinal drugs in treating hypertension based on efficacy. CONCLUSION: Unlike pharmacy practice, verbal claims are common practice in health food stores, despite the lack of either written claims and/or proof of efficacy for most of them. These may be a very effective approach given that 30-40% of North American adults are functionally illiterate. These verbal claims are often inappropriate and not evidence-based.
Adolescent↗
Novel approaches to the diagnosis of fetal alcohol spectrum disorder.
The diagnosis of fetal alcohol spectrum disorder is a difficult task, especially in cases where clear, physical markers of in utero alcohol exposure are not apparent. Reviewed in the following paper are some older tools for screening alcohol use in pregnancy and present novel approaches to the diagnosis of FASD, including ethanol biomarker development to behavioural phenotyping. Improving current FASD diagnostic methodology through more novel approaches may provide the possibility of earlier and wider diagnosis, allowing intervention and treatment at stages where the advanced effects of alcohol can still be mitigated.
Alcohols↗
Pharmacogenetics of morphine poisoning in a breastfed neonate of a codeine-prescribed mother.
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Breast Feeding↗
Pregnancy outcome after first-trimester exposure to metformin: a meta-analysis.
OBJECTIVE: To conduct a systematic review and meta-analysis of pregnancy outcome after metformin use for polycystic ovary syndrome (PCOS), because the efficacy of metformin has been demonstrated in the treatment of infertility caused by PCOS, whereas the fetal safety of metformin has received very little attention, and the few studies addressing this issue are limited by small sample sizes. DESIGN: Meta-analytic review. SETTING: All pertinent studies in MEDLINE and EMBASE from 1966 to September 2004. PATIENT(S): Women with PCOS or diabetes. INTERVENTION(S): Exposure to metformin in the first trimester of pregnancy. MAIN OUTCOME MEASURE(S): Major malformations. RESULT(S): Eight studies were included in the meta-analysis, with an odds ratio of 0.50 (95% confidence interval, 0.15, 1.60). After adjustment for publication bias, metformin treatment in the first trimester was associated with a statistically significant 57% protective effect. After pooling the studies, the malformation rate in the disease-matched control group was approximately 7.2%, statistically significantly higher than the rate found in the metformin group (1.7%). CONCLUSION(S): On the basis of the limited data available today, there is no evidence of an increased risk for major malformations when metformin is taken during the first trimester of pregnancy. Large studies are needed to corroborate these preliminary results.
Abnormalities, Drug-Induced↗