Pregnancy Category Research Articles

Women's questions about medicines in pregnancy – An analysis of calls to an Australian national medicines call centre

For many medicines, safe use during pregnancy is not established and adherence is often poor due to safety concerns. Therefore, it is important to identify consumers' medicines information needs during pregnancy. A retrospective, mixed methods analysis was conducted on eight years of pregnancy-related calls to an Australian national medicines call centre. The call profile of pregnancy and non-pregnancy-related questions were compared. Medicines involved in pregnancy calls were categorised by class (Anatomical Therapeutic Chemical (ATC)3 level), and Therapeutic Goods Administration pregnancy category. Questions in these calls were also themed by pregnancy stage. We identified 4573 pregnancy-related and 118 547 non-pregnancy-related calls. The caller profile for pregnancy-related calls was female (93.7%), asking for herself (83.0%), and while 70.1% of questions involved one medicine, 9.6% involved three or more medicines. Pregnancy enquiries were prompted more often by conflicting information, inadequate information or desire for a second opinion. For 1166 calls, where the stage of pregnancy was available, most questions concerned safety. Medication classified as 'safe' during pregnancy accounted for 34% of these questions. After antidepressants, most calls were made about over-the-counter (OTC) medicines (paracetamol, dexchlorpheniramine, codeine). Safe treatment for everyday conditions was of increasing concern as the pregnancy progressed. Pregnant women are concerned about the safety of medication use in pregnancy and a significant proportion overestimate risk. Psychotropic medication and fertility are strong drivers to seek information during preconception. Everyday illnesses and self-medication with OTC medication are a common concern throughout pregnancy, even though many medicines are safe to use.

New prescription drug labeling for pregnant or nursing women

New prescription drug labeling for pregnant or nursing women

Exclusion of Women of Childbearing Potential in Clinical Trials of Type 2 Diabetes Medications: A Review of Protocol-Based Barriers to Enrollment.

Women of childbearing potential are often excluded from participating in clinical trials owing to concerns about adverse fetal effects of treatment. This study aims to determine the prevalence of fertility-related exclusion criteria in clinical trials of type 2 diabetes medications and to determine whether these criteria are commensurate with drug risk. ClinicalTrials.gov was queried for trials of type 2 diabetes medications that were phase 2 or 3, were based in the U.S., and enrolled participants 18-40 years old. Six hundred eighty-eight trials met criteria. Information collected about each trial included enrollment, trial length, exclusion and inclusion criteria, trial sponsor, and pregnancy category of drug(s) administered. Most studies (59%) included one or more fertility-related exclusion criteria, most often excluding current pregnancy (55%) and breast-feeding (44%). Trials of medications with increased fetal risk were not more restrictive: trials of category C drugs (evidence of fetal risks in animals) were less likely to exclude pregnancy compared with trials of category B drugs (no known human or animal fetal risks) (45.6% vs. 69.8%, odds ratio [OR] 0.37 [95% CI 0.20, 0.65], P = 0.0005) or to require contraceptive use (29.9% vs. 57.1%, OR 0.32 [95% CI 0.18, 0.56], P = 0.001). In clinical trials of type 2 diabetes medications, exclusion criteria affecting women of childbearing potential are often disproportionate to risk to the participant and fetus. These criteria have the potential to impede young women's access to clinical trials and may hinder the acquisition of clinical knowledge critical for improving the care of women with diabetes.

Mitoxantrone exposure in pregnancy: a new case report in a multiple sclerosis patient

Abstract Background: Mitoxantrone (MIX) is a chemotherapeutic agent used in aggressive multiple sclerosis (MS). It is considered a potential human teratogen and it is classified by the US Food and Drug Administration in pregnancy category D. There are some cases reported of MIX exposure in the pregnancy or preconception period, four in polytherapy in oncological patients and two in MS women. In the first MS case, the baby had low birth weight; in the second the infant suffered from the Pierre Robin sequence. Case history: We describe a 24-year-old female with MS. She started MIX treatment after 4 months from diagnosis, receiving a cumulative dose of 60 mg/m2 and a total of six infusions since discovering she was pregnant. The last infusion was after the supposed conception day. The pregnancy was regular, with growth restriction during the entire period. On week 39, the patient delivered a healthy baby. Her weight was 2.314 kg (<5th percentile), the length 45 cm (<5th percentile), and the cranial circumference 30 cm. Conclusions: We described the third case of MIX exposition in MS-pregnant patients. The only consequence was low birth weight. It is important to collect all the accidental MIX exposition in pregnancy to have more safety data.

Sexual health behaviors and outcomes among current and former foster youth: A review of the literature

This review examines literature related to pregnancy, sexual health outcomes, and sexual risk behaviors for foster youth and youth who are aging/have aged out of foster care. Using the search terms foster youth, aging out, pregnancy, sexually transmitted diseases, sexually transmitted infections, sexual risk, sexual behavior, and sexual health, 26,376 sources were initially identified. After removing duplicate sources and those that did not meet inclusion criteria and adding others identified through the references of identified sources, 53 sources were included in the review. Outcome measures were grouped into broad categories of pregnancy, sexually transmitted infections, and risky sexual behaviors, with each having several subparts. Implications for social work practice and policy are presented and directions for future research are highlighted.

Rationality and Ethics of Promotional Drug Literature in Medical Journals

Introduction: Currently irrational prescribing is a major concern to community physicians. The promotional drug literature of pharmaceutical companies in medical journal is an important mode to get the information about new drug being introduced and marketed in the country. Most of the community physician depends completely on these published dug literatures. That’s why it is important to maintain high standards of quality of drug advertisement published in medical journals and thus help physician prescribe drugs in a rational manner. Aims and Objective: To evaluate and compare the quality of drug promotional advertisement published in an Indian and international medical journal and highlight the measures to improve the quality of drug advertisement. Materials and Methods: It was an observational cross sectional study of promotional drug advertisements published in two medical journals i.e. one Indian and one international journal over a period of one year [June-2014 to June-2015]. Advertisements pertaining to parenteral fluids, milk foods, medical devices, laboratory equipment and the educational advertisements were excluded. The identified published drug advertisements were evaluated for adherence to the ethical guidelines of World Health Organization (WHO) or the Organisation of Pharmaceutical Producers of India (OPPI). Results: A total of 76 and 35 medicinal drug advertisements were published in an Indian and an international medical journal respectively. There was a significant difference in compliance to WHO criteria among Indian (43.5±35.2) and international (70.6±23.8) journal [p< 0.05]. Only brand name and manufacturer details were provided in all the promotional drug literature i.e. 100% compliance. There was significant difference in the compliance to WHO criteria for active ingredient causing adverse reaction, pregnancy category, precaution and contraindication, drug interaction, dosage regimen and date of production in the two journals. Conclusion: The compliance criteria are frequently overlooked by the medical journal publishers. It is expected that the promotional drug literature may be thoroughly checked for compliance more so by the reputed Indian than an international medical journal.

Adolescents Prescribed Teratogenic Medications Infrequently Receive Contraception

Fewer than 50% of women prescribed teratogenic medications by internists or family physicians receive contraceptives. To determine the prevalence in a pediatric setting, investigators at an academic medical center retrospectively reviewed electronic medical records (EMRs) for 1700 female patients (mean age, 16) who were prescribed drugs labeled pregnancy category risk D or X at hospital discharge or outpatient visits between 2008 and …

Pregnancy outcomes following exposure to onabotulinumtoxinA

PurposeTo evaluate pregnancy outcomes following onabotulinumtoxinA (US Food and Drug Administration pregnancy category C product) exposure using the Allergan safety database.MethodsThe Allergan Global Safety Database contains reports of onabotulinumtoxinA administration before/during pregnancy, including both prospective (reported before outcome) and retrospective (outcome already known) cases. The database was searched from 1/1/90 to 12/31/13 for eligible cases where treatment occurred during pregnancy or ≤3 months before conception. To minimize reporting bias, prevalence rates were focused on prospective cases.ResultsOf 574 pregnancies with maternal onabotulinumtoxinA exposure, 232 were eligible with known outcomes. Patients received onabotulinumtoxinA most frequently for cosmetic indications (50.5%), movement disorders (16.8%), and pain disorders (14.2%). Of the 137 with dose information, 40.1% received <50U, 14.6% 50U to <100U, 27.7% 100U to <200U, and 17.5% ≥200U. Among 146 cases with known maternal age, 47.9% were ≥35 years. Most (96.0%) fetal exposures occurred during/before the first trimester. Of the 137 prospective cases (139 fetuses), 110 (79.1%) were live births; 29 (20.9%; 95% CI, 14.0–30.0%) ended in fetal loss (21 spontaneous, 8 induced abortions). Among live births, 106 (96.4%) were normal, with four abnormal birth outcomes (1 major fetal defect, 2 minor fetal malformations, 1 birth complication), giving a 2.7% (3/110; 95% CI, 0.6–8.0%) prevalence rate for overall fetal defects.ConclusionsA 24‐year retrospective review of the Allergan safety database shows that the prevalence of fetal defects in onabotulinumtoxinA‐exposed mothers before/during pregnancy (2.7%) is comparable with background rates in the general population. Pregnancy outcome monitoring in onabotulinumtoxinA‐exposed women continues. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

Pharmacists' knowledge of the safety of antibiotics for systemic use.

Pharmacists' knowledge of the safety of antibiotics for systemic use.

Abstract 16466: Total Number of Pregnancies and Atrial Fibrillation Risk: The Women’s Health Study

Introduction: Parity has been associated with an increased risk of cardiovascular disease (CVD), which is thought to be mediated by obesity and insulin resistance. However, the relationship between parity and atrial fibrillation (AF) remains unclear. Methods: We examined 34,636 female health professionals aged ≥45 years and free of AF or CVD at baseline within the Women’s Health Study. Women were prospectively followed for development of new-onset AF, which was confirmed by medical record review. Cox proportional hazards models were used to evaluate the relationship between total number of pregnancies ≥6 months in duration (0-1 [referent], 2-3, 4-5, 6) and incident AF risk. Results: During a median follow-up of 19.2 years, 1467 women developed incident AF. Median baseline age was 52.9 [IQR 48.9, 58.8] years. In multivariable analyses (Table), after adjustment for multiple confounders, including measures of socioeconomic status, hazard ratios (HR) and 95% confidence intervals (95%CI) for incident AF across categories of increasing total number of pregnancies were 1.0, 1.12 (0.94 - 1.33), 1.26 (1.04 - 1.53), and 1.37 (1.06 - 1.76). Further adjustment for time-updated changes in body mass index (BMI), hypertension, diabetes, hypercholesterolemia and other variables did not have a significant impact on these associations. Adjustment for CVD events occurring during follow-up did not significantly alter these results (fully adjusted HRs and 95%CIs across pregnancy categories: 1.0, 1.11 (0.93 - 1.32), 1.25 (1.03 - 1.52), 1.35 (1.05- 1.74); p for linear trend=0.005). Conclusions: In this large prospective cohort, number of prior pregnancies was directly associated with subsequent AF risk among women over age 45. This risk was not mediated by non-fatal CVD events, obesity, and/or diabetes. Repeated exposure to metabolic, physiological and/or hormonal changes during pregnancy may predispose to AF in later life and requires further investigation.

Teratogenic medications and concurrent contraceptive use in women of childbearing ability with epilepsy.

Many antiepileptic drugs (AEDs) have the potential to cause teratogenicity. We evaluated eight antiepileptic drugs (AEDs) classified as Federal Drug Administration (FDA) pregnancy category D, X, or N designations and having documented teratogenic effects. These include carbamazepine, ethosuximide, fosphenytoin, phenobarbital, phenytoin, primidone, topiramate, and valproate. Women with epilepsy (WWE) may need one or more of these AEDs for seizure control but may be unaware of the potential teratogenicity associated with their use. In utero exposure to AEDs increases the risks for both congenital malformations and other teratogenic defects. Given that approximately 50% of pregnancies are unintended, it is likely that women with epilepsy taking these medications could unknowingly put a growing fetus at risk. For women using contraception while taking these medications, many choose combined hormonal contraceptives (CHCs). Drug-drug interactions exist between AEDs and CHCs that may decrease contraceptive efficacy. The aim of this study was to evaluate prescribing patterns for potentially teratogenic AEDs and contraceptive use in WWE of childbearing ability, including those with potential drug-drug interactions. This study also determined the number of WWE of childbearing ability prescribed potentially teratogenic AEDs and documentation of a pregnancy or contraception plan. This was a retrospective, observational study of WWE age 15-44 years, of childbearing ability, prescribed an AED from July 1, 2011 to June 30, 2012, and who had an appointment at the University of Colorado Hospital Outpatient Neurology Clinic (Anschutz Medical Campus). One hundred fifteen women with an average age of 30.7 years and various types of seizures were evaluated. The majority of patients were prescribed topiramate (34/115, 30%) or carbamazepine (27/115, 23%). Of the women, 30/115 (26%) had a documented contraception method when taking a potentially teratogenic AED. Of these women prescribed contraception, most (18/30, 60%) used an oral combined hormonal contraceptive or progestin-only pill, a majority of which had a potential for a drug-drug interaction with their AEDs (16/18, 89%). Less than 7% of women received counseling on a contraception plan, and 18% of subjects received counseling on a pregnancy plan. Most WWE of childbearing ability taking potentially teratogenic AEDs were not using contraception. Those using contraception frequently had a method that has a significant drug-drug interaction which reduces the effectiveness of contraception. Women with epilepsy of childbearing ability prescribed an AED should be using effective contraception or participating in active discussions about pregnancy planning to avoid unplanned pregnancies and possible teratogenic effects of these AEDs. Documentation about pregnancy planning or contraceptive use in WWE of childbearing ability is minimal and should be discussed at least annually. It is critical for providers to discuss with WWE of childbearing ability the benefits and risks of various AED treatments; the need to select appropriate, effective contraception when pregnancy is not desired; and the importance of counseling regarding contraceptive or pregnancy planning.

Drug prescribing pattern in pregnancy in a secondary care hospital in south India: a retrospective study.

In pregnancy drug treatment presents a special concern due potential teratogenic effects and physiologic alterations in mother. This retrospective study was performed to evaluate the drug prescribing pattern in pregnancy among pregnant women in a secondary care hospital in India. This cross-sectional retrospective study was done for 3 months using pre-formatted forms and patient's records. A total of 326 drugs, including 46 different types of drugs, were prescribed to 606 gravid women. Eight different types of medications were started before being seen at the antenatal clinic. Most of these drugs fall under US FDA pregnancy categories B and C and few under categories A, X and N. This study reflects a good, safe and rational medication practice during pregnancy in various common disorders in a secondary care hospital and can be cited as an example to similar primary and secondary care hospitals.

Frequency and type of medications and vaccines used during pregnancy.

Providing safe pharmacotherapy for pregnant women is challenging. Nearly all pregnant women are prescribed or inadvertently receive medication during their pregnancy. We reviewed the scientific literature to identify the specific medications and vaccines that are most often used during pregnancy and described them by category and indication. Our interest was to update the research before the implementation of the recently released FDA labeling rule for pregnancy and lactation that eliminates the use of pregnancy categories in product labels. Our results confirm that most products taken during pregnancy are over-the-counter or in the former FDA pregnancy categories A or B. However, medications taken prior to pregnancy recognition (inadvertent exposures) and those prescribed for chronic illness such as allergies, depression, and pain are of concern. A better understanding of medication and vaccine utilization during pregnancy may help clinicians reduce inadvertent first trimester exposures and improve the safe and effective treatment of pregnant women.

Target-specific oral anticoagulants: should we switch from warfarin?

Target-specific oral anticoagulants: should we switch from warfarin?

Women's Neurology

This review details some of the features important to consider in women with neurologic disease, including medication and disease effects on both reproductive health and pregnancy/fetal development, as well as hormonal effects on neurologic disease. A case-based approach is used to discuss diseases that affect women throughout their life cycle (multiple sclerosis [MS] and epilepsy), disorders that affect only women (eclampsia), and those that affect women preferentially (migraine, cerebral venous thrombosis, reversible cerebral vasospasm, and Alzheimer disease). The epidemiology, differential diagnosis, pathophysiology, management, and prognosis are reviewed for each disorder. Tables include US Food and Drug Administration pharmaceutical pregnancy categories, learning objectives, migraine with aura, alternative diagnostic criteria for migraine without aura, migraine aura versus transient ischemic attacks, red flags to secondary headache, abortive headache therapy in pregnancy, migraine preventive medications and pregnancy, MS therapies in pregnancy, pregnancy consulting points for MS patients on a disease-modifying therapy, and general recommendations for women with epilepsy and pregnancy. Figures show fluid-attenuated inversion recovery and gradient echo magnetic resonance images of the right anterior parietal region; a magnetic resonance venogram demonstrating occlusion in the superior sagittal sinus; posterior reversible encephalopathy syndrome; and computed tomographic (CT) images of a hemorrhage in the left parietal region, left frontal subarachnoid bleeding, and left middle cerebral beading. This review contains 5 highly rendered figures, 11 tables, and 29 references.

Women's Neurology

This chapter reviews some of the features important to consider in women with neurologic disease, including medication and disease effects on both reproductive health and pregnancy/fetal development, as well as hormonal effects on neurologic disease. A case-based approach is used to discuss diseases that affect women throughout their life cycle (multiple sclerosis [MS] and epilepsy), disorders that affect only women (eclampsia), and those that affect women preferentially (migraine, cerebral venous thrombosis, reversible cerebral vasospasm, and Alzheimer disease). The epidemiology, differential diagnosis, pathophysiology, management, and prognosis are reviewed for each disorder. Tables include US Food and Drug Administration pharmaceutical pregnancy categories, learning objectives, migraine with aura, alternative diagnostic criteria for migraine without aura, migraine aura versus transient ischemic attacks, red flags to secondary headache, abortive headache therapy in pregnancy, migraine preventive medications and pregnancy, MS therapies in pregnancy, pregnancy consulting points for MS patients on a disease-modifying therapy, and general recommendations for women with epilepsy and pregnancy. Figures show fluid-attenuated inversion recovery and gradient echo magnetic resonance images of the right anterior parietal region; a magnetic resonance venogram demonstrating occlusion in the superior sagittal sinus; posterior reversible encephalopathy syndrome; and computed tomographic (CT) images of a hemorrhage in the left parietal region, left frontal subarachnoid bleeding, and left middle cerebral beading. This chapter contains 5 highly rendered figures, 11 tables, 29 references, and 5 MCQs.

Abstract OT3-1-07: MotHER: A US registry for women with breast cancer who have received trastuzumab, pertuzumab in combination with trastuzumab, or trastuzumab emtansine (T-DM1) during pregnancy or within 7 months prior to conception

Abstract Background: Trastuzumab (Herceptin) and pertuzumab (Perjeta) are HER2-targeted monoclonal antibodies, and T-DM1 (Kadcyla) is a HER2-targeted antibody–drug conjugate. These molecules are classified as FDA Pregnancy Category D, indicating evidence of fetal harm; there have been postmarketing reports of oligohydramnios in women who received trastuzumab during pregnancy; in non-clinical studies of pertuzumab, oligohydramnios, delayed renal development, and embryo-fetal death occurred in pregnant cynomolgus monkeys. Furthermore, maytansine, the parent molecule of DM1, has demonstrated embryotoxicity in mice. The MotHER pregnancy registry was established in 2008 as an FDA postmarketing commitment to evaluate the effects of trastuzumab on pregnancy outcome. Pertuzumab and T-DM1 were included in the registry following their respective FDA approvals in 2012 and 2013. Study design: MotHER is a US pregnancy registry and uses a prospective, observational cohort design. Enrollment is voluntary and can be initiated by the patient or her healthcare provider. Women are followed up until pregnancy outcome; infants are followed up through the first year of life. Eligibility criteria: Pregnant women ≥18 years of age and resident in the US are eligible if they have received at least one dose of trastuzumab, pertuzumab in combination with trastuzumab, or T-DM1 for breast cancer during pregnancy or within 7 months prior to conception. Enrollment must be initiated before pregnancy outcome is known. Specific aims: The primary outcome measures are pregnancy outcomes and the incidence of pregnancy complications, such as oligohydramnios, congenital anomalies, and fetal/infant functional deficits. Information on potential birth defects, noted either at birth or during pediatric follow-up, is evaluated and classified by a birth defect evaluator/clinical geneticist. Statistical methods: The study is descriptive and not designed for formal hypothesis testing; event rates with 95% confidence intervals will be calculated. Accrual: There is no pre-specified sample size. Data collection is ongoing, from 2009 to 2019 for trastuzumab, from 2012 to 2022 for pertuzumab plus trastuzumab, and from 2013 to 2023 for T-DM1. Fourteen women have enrolled as of January 31, 2014. Citation Format: Vikki Brown, Richard K Miller, Laura Chu, Cheryl Chow, Caroline Trudeau, Elizabeth B Andrews. MotHER: A US registry for women with breast cancer who have received trastuzumab, pertuzumab in combination with trastuzumab, or trastuzumab emtansine (T-DM1) during pregnancy or within 7 months prior to conception [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr OT3-1-07.

Teratogenic Effect of Carbamazepine Administration in Pregnant Rats

Background: Carbamazepine (Tegretol) is an anticonvulsant and mood stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder, as well as trigeminal neuralgia. It has been assigned to pregnancy category D by the U.S Food and Drug Administration (FDA). CBZ can cause fetal harm when administered to pregnant women. Epidemiological data suggested that there may be an association between the use of CBZ during pregnancy and congenital malformations, specifically spina bifida and developmental disorders. The possible malformation-specific risks with CBZ use during pregnancy need to be considered, so the present work was conducted to evaluate the genotoxicity of two doses of CBZ (3.6 mg and 10.8 mg/ 100g body weight/ day) in pregnant female rats and their fetuses. Chromosomal aberration in bone marrow cells and histopathological examination of liver and kidney of pregnant rats were also determined. Materials and Methods: Fourty five pregnant Sprague Dawley rats were randomly divided into the groups. The first was administered oral doses of distilled water and served as control. The other two groups were administered oral doses of CBZ suspended in distilled water equivalent to 3.6 mg and 10.8 mg/100g body weight/day respectively for 15 day from the 6th day to the 20th day of gestation. Females were sacrificed on the 20th day of gestation. Results: Administration of CBZ 3.6 mg and 10.8 mg /100g body weight to pregnant rats from the 6th till the 20thday of gestation. Decreased fetal body weight, crown-rump length, increased resorbed and dead fetuses were observed compared to the control ones. Moreover, CBZ-high dose group(10.8mg/100g) causedmalformations that could be described as severe growth retardation. At the same time, bone marrow metaphases of CBZ-treated pregnant rats revealed structural chromosomal aberrations. Whereas, histopathological examination of liver and kidney of pregnant rats treated with both doses of CBZshowed cellular alterations.Conclusion:It has been found that usage of antiepileptic CBZ during gestational period may create risk, associated with maternal toxicity, hepato- and nephrotoxicity and chromosomal aberrations in pregnant rats, with intrauterine growth retardation which was manifested by low body weight, length reduction and malformations. These alterations were dose dependent. The benefits of taking CBZ must be weighed against the potential risks to boththe developing fetus and the mother.

Triclabendazole sulfoxide causes stage-dependent embryolethality in zebrafish and mouse in vitro.

BackgroundFascioliasis and paragonimiasis are widespread foodborne trematode diseases, affecting millions of people in more than 75 countries. The treatment of choice for these parasitic diseases is based on triclabendazole, a benzimidazole derivative which has been suggested as a promising drug to treat pregnant women and children. However, at the moment, this drug is not approved for human use in most countries. Its potential adverse effects on embryonic development have been scarcely studied, and it has not been assigned a pregnancy category by the FDA. Thus, to help in the process of risk-benefit decision making upon triclabendazole treatment during pregnancy, a better characterization of its risks during gestation is needed.MethodologyThe zebrafish embryo test, a preimplantation and a postimplantation rodent whole embryo culture were used to investigate the potential embryotoxicity/teratogenicity of triclabendazole and its first metabolite triclabendazole sulfoxide. Albendazole and albendazole sulfoxide were included as positive controls.Principal FindingsTriclabendazole was between 10 and 250 times less potent than albendazole in inducing dysmorphogenic effects in zebrafish or postimplantation rodent embryos, respectively. However, during the preimplantation period, both compounds, triclabendazole and triclabendazole sulfoxide, induced a dose-dependent embryolethal effect after only 24 h of exposure in rodent embryos and zebrafish (lowest observed adverse effect concentrations = 10 μM).Conclusions/SignificanceIn humans, after ingestion of the recommended doses of triclabendazole to treat fascioliasis and paragonimiasis (10 mg/kg), the main compound found in plasma is triclabendazole sulfoxide (maximum concentration 38.6 μM), while triclabendazole concentrations are approximately 30 times lower (1.16 μM). From our results it can be concluded that triclabendazole, at concentrations of the same order of magnitude as the clinically relevant ones, does not entail teratogenic potential in vitro during the organogenesis period, but its first metabolite triclabendazole sulfoxide has a high embryotoxic capacity in vitro during the preimplantation stage.

The FDA Revises Pregnancy Risk Information

* The Food and Drug Administration has finalized revisions to the format and content of pregnancy and lactation information in the labeling of prescription drugs and biological products. * The pregnancy categories A, B, C, D, and X will be eliminated. In their place will be “Risk Summary” narratives concerning both pregnancy and lactation. There will also be a summary of information on pregnancy testing, contraception, and infertility under a subheading “Females and Males of Reproductive Potential.”