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Gideon Koren - One of the best experts on this subject based on the ideXlab platform.

  • perception of Teratogenic risk and the rated likelihood of pregnancy termination association with maternal depression
    The Canadian Journal of Psychiatry, 2011
    Co-Authors: Asnat Walfisch, Adrienne Einarson, Corey Sermer, Ilan Matok, Gideon Koren
    Abstract:

    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...

  • drug labeling and risk perceptions of Teratogenicity a survey of pregnant canadian women and their health professionals
    The Journal of Clinical Pharmacology, 2000
    Co-Authors: Meena Pole, Nicholas Pairaudeau, Thomas R. Einarson, Adrienne Einarson, Gideon Koren
    Abstract:

    : There is a general perception that medicinal drugs are not safe in pregnancy despite the fact that fewer than 30 drugs have been shown to cause major malformations in humans. A large number of women need medications in pregnancy to treat pregnancy-induced conditions, acute illnesses, and chronic diseases. The objectives of this study were the following: (1) to characterize the perception of Teratogenic risk by pregnant women and their partners and by health professionals and (2) to examine the most reassuring way to present data on a drug for nausea and vomiting of pregnancy that has been proven to be safe to the fetus. A convenience sample of pregnant Canadian women and their partners, pharmacists, nurses, physicians, and hospital workers were asked to choose the "safest" among four drugs by statements describing their safety. Although the text of all four was similar, the title and narrative were modified to be more or less "reassuring" by the use of more or less terms such as malformations and abnormalities. Health professionals rated the Teratogenic risk significantly lower than the parents, but even they rated the drugs as not safe, despite a scientifically reassuring text. Sixty percent of the 240 participants, regardless of their perception of Teratogenic risk, believed the four drugs were of similar risks. However, in the other 40%, the less "reassuring" text led to higher Teratogenic perception, and the more reassuring options tended to decrease the false perception of Teratogenic risk. It was concluded that in general, four different versions of reassuring text describing a scientifically proven safe drug in pregnancy did not lead expecting parents to believe they were safe. Among those who did not rank the four drugs as having equal safety/risk, the less "reassuring" text led to a higher perception of Teratogenic risk. Even health professionals reading the labels describing safe drugs rated them as unsafe. Presently, the perception of Teratogenic risk is strong even for safe drugs and is difficult to change even with evidence-based facts.

  • the perception of Teratogenic risk by women with nausea and vomiting of pregnancy
    Reproductive Toxicology, 1999
    Co-Authors: Paolo Mazzotta M S C, Laura A Magee, Caroline Maltepe M A, Arielah Lifshitz, Yvette Navioz, Gideon Koren
    Abstract:

    This study determined the advice reported to be received by women suffering from nausea and vomiting of pregnancy (NVP) from their caregivers regarding management, the Teratogenic risk perception of these women and their choice of antiemetic drug use in pregnancy. A secondary objective was to determine prospectively the effect of counseling on malformation risk perception in women with NVP. The women were prospectively followed-up and questioned about the use of pharmacotherapy or other management choices as well as their perception of Teratogenic risk through structured telephone interviews. The results showed that at the initial call, around 6 weeks of gestation, over three quarters of the 260 participants reported that therapy of NVP increased their Teratogenic risk, This risk perception was decreased significantly after counseling. Women who reported their physicians' advice to change their diet and/or lifestyle attributed an increased risk for major malformations with antiemetics for NVP (P = 0.001), whereas women who reported advice to take antiemetic medications known to be safe to the fetus attributed no change in risk for major malformations with drugs for NVP (P = 0.002). We came to the conclusion that women are commonly hesitant to treat NVP pharmacologically due to unfounded fears of Teratogenic risk. Evidenced-based counseling resulted in reduced numbers of women who considered drug therapy for NVP to increase the risk of major malformations.

  • The perception of Teratogenic risk of cocaine
    Teratology, 1992
    Co-Authors: Gideon Koren, David J. Gladstone, Christine Robeson, Isabelle Robieux
    Abstract:

    While there has been a substantial increase in recreational use of cocaine by young adults, conclusive evidence for cocaine Teratogenicity in humans is lacking, and even those believing the drug is Teratogenic agree that the rates are quite small. While counseling pregnant women on their Teratogenic risk, it was our impression that there is an unrealistically high perception of reproductive risk of cocaine. We wished to quantify the perception of Teratogenic risk of cocaine by the public, physicians, and by pregnant women who were counseled following gestational exposure to the drug. Women taking cocaine during the first trimester of pregnancy (n = 54), controls with post secondary education (n = 30), and physicians (n = 30) were asked, using a visual analogue scale, to quantify the Teratogenic risk of cocaine and the tendency to terminate/continue the pregnancy after first trimester exposure; in the case of the "public" and physicians this was a hypothetical question. Both physicians and the controls perceived cocaine to be Teratogenic (13.4 +/- 11% risk of major malformations by physicians, and 56.5 +/- 22.8% by the "public"). The controls believed cocaine to be as hazardous as thalidomide (57.2 +/- 25.6% risk for thalidomide). Asked whether they would wish to terminate such pregnancy in their family, most physicians (56%) and the controls (70%) had a greater than 50% tendency to terminate.(ABSTRACT TRUNCATED AT 250 WORDS)

Eleanor Bimla Schwarz - One of the best experts on this subject based on the ideXlab platform.

  • provision of potentially Teratogenic medications to female veterans of childbearing age
    Medical Care, 2010
    Co-Authors: Eleanor Bimla Schwarz, Lisa Longo, Xinhua Zhao, Roslyn A Stone, Francesca E Cunningham, Chester B Good
    Abstract:

    BACKGROUND: Certain medications increase the risk of birth defects whether used during pregnancy or immediately preconception. OBJECTIVES: To describe dispensing of potentially Teratogenic medications (Food and Drug Administration classes D or X) to female Veterans treated by the Veterans Affairs (VA) Healthcare System, and assess whether documented provision of family planning services is more common when potentially Teratogenic medications are prescribed. RESEARCH DESIGN: We examined all 2,634,441 prescriptions filled in fiscal year 2007 or 2008 by 78,232 female Veterans, aged 18 to 45, who made >or=2 visits to VA clinics within the year prior to medication dispensing from VA pharmacies. MEASURES: : Medications dispensed, contraceptive counseling, and pregnancy testing. RESULTS: Prescriptions for potentially Teratogenic medications were filled by 48.8% of female Veterans who received medications from a VA pharmacy. Women who filled prescriptions for potentially Teratogenic medications were only slightly more likely to have documented family planning services (eg, contraception, contraceptive counseling, or pregnancy testing) than women who filled class C, but not class D or X, prescriptions (55.7% vs. 51.8%). Women filling only class A or B prescriptions were least likely to have documented family planning services (35.9%). Among women dispensed potentially Teratogenic medications, family planning services were significantly more likely to be documented for women who were >or=25 years (odds ratio [OR], 2.82; 95% confidence interval [CI], 2.57-3.11), unmarried (OR, 1.30; 95% CI, 1.23-1.35), non-White (OR, 1.17; 95% CI, 1.09-1.26), seen at a women's clinic (OR, 1.96; 95% CI, 1.88-2.05), received a retinoid medication (OR, 7.72; 95% CI, 3.02-19.7), or had serious mental illness (OR, 1.26; 95% CI, 1.18-1.34). CONCLUSIONS: Medications that may cause birth defects if used during pregnancy are dispensed frequently to female Veterans by VA pharmacies without documented receipt of contraceptive counseling or pregnancy testing.

  • perspectives of primary care clinicians on Teratogenic risk counseling
    Birth Defects Research Part A-clinical and Molecular Teratology, 2009
    Co-Authors: Eleanor Bimla Schwarz, Aimee K Santucci, Sonya Borrero, Aletha Y Akers, Cara Nikolajski, Melanie A Gold
    Abstract:

    Background—Women of childbearing age are commonly prescribed medications by primary care providers (PCPs) that may cause birth defects if used during pregnancy. Methods—To identify what PCPs perceive as barriers to and potential facilitators of providing counseling to women of childbearing age when Teratogenic medications are prescribed, we conducted 8 focus groups with 48 PCPs recruited from 4 clinical settings in Pittsburgh, PA. We explored PCPs’ experiences counseling women about Teratogenic medications. Each focus group was audio-recorded, transcribed, and coded using a grounded theory approach by 3 independent coders. Results—PCPs feel responsible for counseling women when they prescribe medications that may cause birth defects, but note difficulties identifying clinically-relevant sources of information on Teratogenicity. Other barriers to providing counseling include limited visit times and lack of reimbursement for preconception or Teratogenic risk counseling. PCPs find it challenging to identify patients who may become pregnant and who therefore need contraceptive and/or Teratogenic risk counseling. PCP’s expressed a desire for online resources that could be used when explaining medication risks to patients. PCPs feel that the development of patient information materials, electronic decision support tools, clinical care systems that routinely assess patients’ pregnancy risk, and changes in the reimbursement structure may facilitate counseling patients about Teratogenic risks.

  • prescription of Teratogenic medications in united states ambulatory practices
    The American Journal of Medicine, 2005
    Co-Authors: Eleanor Bimla Schwarz, Judith H. Maselli, Mary E. Norton, Ralph Gonzales
    Abstract:

    Abstract Purpose The purpose of this study was to identify the potentially Teratogenic medications most frequently prescribed to women of childbearing age and the specialty of physicians who provide ambulatory care to women who use such medications. In addition, we evaluated rates of contraceptive counseling to explore awareness of the risks associated with Teratogenic medication use. Subjects and methods The prescription of Teratogenic medications and provision of contraceptive counseling on 12 681 visits made by nonpregnant women, 14 to 44 years of age, to 1880 physicians in US ambulatory practice (National Ambulatory Medical Care Survey) between 1998 and 2000 was analyzed. Results Use of a potentially Teratogenic, class D or X, medication by a woman of childbearing age is documented on 1 of every 13 visits made to US ambulatory practices. These include anxiolytics (4.1 million annual prescriptions), anticonvulsant medications (1.4 million annual prescriptions), antibiotics like doxycycline (1.4 million annual prescriptions), and statins (0.8 million annual prescriptions). Isotretinoin accounts for less than 5% of potentially Teratogenic prescriptions (0.5 million annual prescriptions). Internists and family/general practitioners provide ambulatory care to 45% of women prescribed potentially Teratogenic medications, psychiatrists provide ambulatory care to 20% of women prescribed potentially Teratogenic medications, and dermatologists provide ambulatory care to 20% of women prescribed potentially Teratogenic medications. Contraceptive counseling was provided on less than 20% of visits that documented use of a potential teratogen by a woman of childbearing age. Women using low-risk (class A or B) drugs received contraceptive counseling as frequently as women using potential teratogens ( P = .24). Conclusion Potentially Teratogenic medications are prescribed to millions of women of childbearing age each year. Physician awareness of the Teratogenic risk associated with class D or X medications seems low.

  • Prescription of Teratogenic medications in United States ambulatory practices
    The American journal of medicine, 2005
    Co-Authors: Eleanor Bimla Schwarz, Judith H. Maselli, Mary E. Norton, Ralph Gonzales
    Abstract:

    The purpose of this study was to identify the potentially Teratogenic medications most frequently prescribed to women of childbearing age and the specialty of physicians who provide ambulatory care to women who use such medications. In addition, we evaluated rates of contraceptive counseling to explore awareness of the risks associated with Teratogenic medication use. The prescription of Teratogenic medications and provision of contraceptive counseling on 12,681 visits made by nonpregnant women, 14 to 44 years of age, to 1880 physicians in US ambulatory practice (National Ambulatory Medical Care Survey) between 1998 and 2000 was analyzed. Use of a potentially Teratogenic, class D or X, medication by a woman of childbearing age is documented on 1 of every 13 visits made to US ambulatory practices. These include anxiolytics (4.1 million annual prescriptions), anticonvulsant medications (1.4 million annual prescriptions), antibiotics like doxycycline (1.4 million annual prescriptions), and statins (0.8 million annual prescriptions). Isotretinoin accounts for less than 5% of potentially Teratogenic prescriptions (0.5 million annual prescriptions). Internists and family/general practitioners provide ambulatory care to 45% of women prescribed potentially Teratogenic medications, psychiatrists provide ambulatory care to 20% of women prescribed potentially Teratogenic medications, and dermatologists provide ambulatory care to 20% of women prescribed potentially Teratogenic medications. Contraceptive counseling was provided on less than 20% of visits that documented use of a potential teratogen by a woman of childbearing age. Women using low-risk (class A or B) drugs received contraceptive counseling as frequently as women using potential teratogens (P = .24). Potentially Teratogenic medications are prescribed to millions of women of childbearing age each year. Physician awareness of the Teratogenic risk associated with class D or X medications seems low.

Joan K Lemen - One of the best experts on this subject based on the ideXlab platform.

  • assessing the predictive validity of frog embryo teratogenesis assay xenopus fetax
    Teratogenesis Carcinogenesis and Mutagenesis, 2000
    Co-Authors: Douglas J. Fort, Donna R. Farmer, Enos L. Stover, Joan K Lemen
    Abstract:

    The ability of frog embryo teratogenesis assay — Xenopus (FETAX) to identify the potential developmental toxicity of a group of diverse chemicals was evaluated by comparison with results from in vivo studies in rats. A total of 12 chemicals, three of which were shown to be Teratogenic in vivo, four of which were embryolethal (but not Teratogenic) in vivo, and five which did not produce any developmental toxicity in vivo in the rat were evaluated using FETAX. Results of the FETAX test with these 12 blind-coded compounds correctly predicted that three chemicals had strong Teratogenic potential, four had low Teratogenic hazard potential but were embryolethal, and five posed little if any developmental toxicity hazard. In addition, this study concluded that within a family of chemistry analogs could be ranked according to relative Teratogenic hazard and that for the Teratogenic compounds the types of malformations induced in Xenopus mimicked the abnormalities induced in vivo in rats. In summary, these results confirmed that the FETAX assay is predictive and can be useful in an integrated biological hazard assessment for the preliminary screening of chemicals. Teratogenesis Carcinog. Mutagen. 20:87–98, 2000. © 2000 Wiley-Liss, Inc.

  • Assessing the predictive validity of frog embryo teratogenesis assay—Xenopus (FETAX)
    Teratogenesis Carcinogenesis and Mutagenesis, 2000
    Co-Authors: Douglas J. Fort, Donna R. Farmer, Enos L. Stover, Joan K Lemen
    Abstract:

    The ability of frog embryo teratogenesis assay — Xenopus (FETAX) to identify the potential developmental toxicity of a group of diverse chemicals was evaluated by comparison with results from in vivo studies in rats. A total of 12 chemicals, three of which were shown to be Teratogenic in vivo, four of which were embryolethal (but not Teratogenic) in vivo, and five which did not produce any developmental toxicity in vivo in the rat were evaluated using FETAX. Results of the FETAX test with these 12 blind-coded compounds correctly predicted that three chemicals had strong Teratogenic potential, four had low Teratogenic hazard potential but were embryolethal, and five posed little if any developmental toxicity hazard. In addition, this study concluded that within a family of chemistry analogs could be ranked according to relative Teratogenic hazard and that for the Teratogenic compounds the types of malformations induced in Xenopus mimicked the abnormalities induced in vivo in rats. In summary, these results confirmed that the FETAX assay is predictive and can be useful in an integrated biological hazard assessment for the preliminary screening of chemicals. Teratogenesis Carcinog. Mutagen. 20:87–98, 2000. © 2000 Wiley-Liss, Inc.

Ralph Gonzales - One of the best experts on this subject based on the ideXlab platform.

  • prescription of Teratogenic medications in united states ambulatory practices
    The American Journal of Medicine, 2005
    Co-Authors: Eleanor Bimla Schwarz, Judith H. Maselli, Mary E. Norton, Ralph Gonzales
    Abstract:

    Abstract Purpose The purpose of this study was to identify the potentially Teratogenic medications most frequently prescribed to women of childbearing age and the specialty of physicians who provide ambulatory care to women who use such medications. In addition, we evaluated rates of contraceptive counseling to explore awareness of the risks associated with Teratogenic medication use. Subjects and methods The prescription of Teratogenic medications and provision of contraceptive counseling on 12 681 visits made by nonpregnant women, 14 to 44 years of age, to 1880 physicians in US ambulatory practice (National Ambulatory Medical Care Survey) between 1998 and 2000 was analyzed. Results Use of a potentially Teratogenic, class D or X, medication by a woman of childbearing age is documented on 1 of every 13 visits made to US ambulatory practices. These include anxiolytics (4.1 million annual prescriptions), anticonvulsant medications (1.4 million annual prescriptions), antibiotics like doxycycline (1.4 million annual prescriptions), and statins (0.8 million annual prescriptions). Isotretinoin accounts for less than 5% of potentially Teratogenic prescriptions (0.5 million annual prescriptions). Internists and family/general practitioners provide ambulatory care to 45% of women prescribed potentially Teratogenic medications, psychiatrists provide ambulatory care to 20% of women prescribed potentially Teratogenic medications, and dermatologists provide ambulatory care to 20% of women prescribed potentially Teratogenic medications. Contraceptive counseling was provided on less than 20% of visits that documented use of a potential teratogen by a woman of childbearing age. Women using low-risk (class A or B) drugs received contraceptive counseling as frequently as women using potential teratogens ( P = .24). Conclusion Potentially Teratogenic medications are prescribed to millions of women of childbearing age each year. Physician awareness of the Teratogenic risk associated with class D or X medications seems low.

  • Prescription of Teratogenic medications in United States ambulatory practices
    The American journal of medicine, 2005
    Co-Authors: Eleanor Bimla Schwarz, Judith H. Maselli, Mary E. Norton, Ralph Gonzales
    Abstract:

    The purpose of this study was to identify the potentially Teratogenic medications most frequently prescribed to women of childbearing age and the specialty of physicians who provide ambulatory care to women who use such medications. In addition, we evaluated rates of contraceptive counseling to explore awareness of the risks associated with Teratogenic medication use. The prescription of Teratogenic medications and provision of contraceptive counseling on 12,681 visits made by nonpregnant women, 14 to 44 years of age, to 1880 physicians in US ambulatory practice (National Ambulatory Medical Care Survey) between 1998 and 2000 was analyzed. Use of a potentially Teratogenic, class D or X, medication by a woman of childbearing age is documented on 1 of every 13 visits made to US ambulatory practices. These include anxiolytics (4.1 million annual prescriptions), anticonvulsant medications (1.4 million annual prescriptions), antibiotics like doxycycline (1.4 million annual prescriptions), and statins (0.8 million annual prescriptions). Isotretinoin accounts for less than 5% of potentially Teratogenic prescriptions (0.5 million annual prescriptions). Internists and family/general practitioners provide ambulatory care to 45% of women prescribed potentially Teratogenic medications, psychiatrists provide ambulatory care to 20% of women prescribed potentially Teratogenic medications, and dermatologists provide ambulatory care to 20% of women prescribed potentially Teratogenic medications. Contraceptive counseling was provided on less than 20% of visits that documented use of a potential teratogen by a woman of childbearing age. Women using low-risk (class A or B) drugs received contraceptive counseling as frequently as women using potential teratogens (P = .24). Potentially Teratogenic medications are prescribed to millions of women of childbearing age each year. Physician awareness of the Teratogenic risk associated with class D or X medications seems low.

Lindhout D - One of the best experts on this subject based on the ideXlab platform.

  • Pharmacogenetics and drug interactions : role in antiepileptic-drug-induced teratogenesis
    Neurology, 1992
    Co-Authors: Lindhout D
    Abstract:

    Metabolism of antiepileptic drugs (AEDs) is a potentially major factor in AED-induced teratogenesis. When the parent compound is the Teratogenic agent, pharmacogenetic variability in enzymatic metabolism and induction or inhibition of these enzymes by comedication are codeterminants of the Teratogenic potential. When one of the parent compound's metabolites is the Teratogenic agent, the balance between metabolic activation and detoxification is relevant to the Teratogenic activity. Increased metabolic activation, decreased detoxification, or both will induce accumulation of the reactive metabolite