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Obstetric Medicine Mar 2016Nausea and vomiting of pregnancy (NVP) is a common condition affecting 75% of pregnant women. NVP generally commences early in the first trimester, peaking in severity... (Review)
Review
Nausea and vomiting of pregnancy (NVP) is a common condition affecting 75% of pregnant women. NVP generally commences early in the first trimester, peaking in severity between 7 and 12 weeks and in over 90% symptoms will have abated by week 20. Thus, the time when women are most likely to have NVP and require treatment coincides with the embryonic period when there is maximum susceptibility to any teratogenic risk. Following the thalidomide tragedy of 55 years ago there is a particular awareness and sensitivity about these potential risks, especially in relation to any medication used to treat NVP. Despite several studies showing no clear benefits of ondansetron over other NVP treatments such as doxylamine, and the paucity of safety data, the off-label prescribing and use of ondansetron to treat NVP has increased significantly worldwide. Albeit based on limited human pregnancy data, ondansetron has not been associated with a significantly increased risk of birth defects or other adverse pregnancy outcomes. This review attempts to highlight some of the difficulties in interpreting the available data and the need to follow practical guidelines regarding treatment of NVP.
PubMed: 27512487
DOI: 10.1177/1753495X15621154 -
International Journal of Women's Health 2014Nausea and vomiting in pregnancy (NVP) is common and often undertreated, in part due to fears of adverse effects of medications on the fetus during early pregnancy. In... (Review)
Review
Nausea and vomiting in pregnancy (NVP) is common and often undertreated, in part due to fears of adverse effects of medications on the fetus during early pregnancy. In April 2013, the US Food and Drug Administration (FDA) approved doxylamine succinate 10 mg and pyridoxine hydrochloride (a vitamin B6 analog) 10 mg as a delayed-release combination pill called Diclegis for the treatment of NVP. Diclegis is currently the only medication that is FDA-approved for the indication of NVP. This review addresses the historical context, safety, efficacy, pharmacology, and practical role of doxylamine and pyridoxine for the management of NVP. The reintroduction of this doxylamine-pyridoxine combination pill into the American market fills a therapeutic gap in the management of NVP left by the removal of the same active drugs marketed over 30 years ago in the form of Bendectin. The substantial amount of safety data accumulated over the years makes it one of the few drugs that qualify for FDA Pregnancy Category A status. In the hierarchical approach to pharmacological treatment of NVP, the combination of doxylamine and pyridoxine should thus be first-tier.
PubMed: 24748822
DOI: 10.2147/IJWH.S46653 -
PloS One 2018Doxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed. We re-analysed the findings of a... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Doxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed. We re-analysed the findings of a previously reported superiority trial of doxylamine-pyridoxine for the treatment of nausea and vomiting during pregnancy using the clinical study report obtained from Health Canada.
METHODS AND FINDINGS
We re-analysed individual level data for a parallel arm randomized controlled trial that was conducted in six outpatient obstetrical practices in the United States. Pregnant women between 7 and 14 weeks of gestation with moderate nausea and vomiting of pregnancy symptoms. The active treatment was a tablet containing both doxylamine 10 mg and pyridoxine 10 mg taken between 2 and 4 times per day for 14 days depending on symptoms. The control was an identical placebo tablet taken using the same instructions. The primary outcome measure was improvement in nausea and vomiting of symptoms scores using the 13-point pregnancy unique quantification of emesis scale between baseline and 14 days using an ANCOVA. 140 participants were randomized into each group. Data for 131 active treatment participants and 125 control participants were analysed. On the final day of the trial, 101 active treatment participants and 86 control participants provided primary outcome measures. There was greater improvement in symptoms scores with doxylamine-pyridoxine compared with placebo (0.73 points; 95% CI 0.21 to 1.25) when last observation carried forward imputation was used for missing data but the difference is not statistically significant using other approaches to missing data (e.g. 0.38; 95% CI -0.08 to 0.84 using complete data).
CONCLUSIONS
There is a trend towards efficacy for nausea and vomiting symptoms with doxylamine-pyridoxine compared with placebo but the statistical significance of the difference depends on the method of handling missing data and the magnitude of the difference suggests that there is no clinically important benefit employing the prespecified minimal clinically important difference or "expected difference" of 3 points.
TRIAL REGISTRATION
Clinical Trial NCT00614445.
Topics: Doxylamine; Drug Therapy, Combination; Female; Humans; Morning Sickness; Placebos; Pregnancy; Pyridoxine
PubMed: 29342163
DOI: 10.1371/journal.pone.0189978 -
P & T : a Peer-reviewed Journal For... Jan 2017Olaratumab (Lartruvo) for the treatment of soft tissue sarcoma; bezlotoxumab (Zinplava) for use with an antibiotic to reduce recurrence of infection; and doxylamine...
Olaratumab (Lartruvo) for the treatment of soft tissue sarcoma; bezlotoxumab (Zinplava) for use with an antibiotic to reduce recurrence of infection; and doxylamine succinate/pyridoxine hydrochloride (Bonjesta) for the treatment of nausea and vomiting during pregnancy.
PubMed: 28090157
DOI: No ID Found -
Paediatric Drugs Jun 2014Nausea and vomiting of pregnancy (NVP) affects up to 85 % of all pregnancies. Effective treatment can greatly improve a woman's quality of life, reduce the risk for... (Review)
Review
Nausea and vomiting of pregnancy (NVP) affects up to 85 % of all pregnancies. Effective treatment can greatly improve a woman's quality of life, reduce the risk for maternal and fetal complications, and reduce healthcare costs. Unfortunately, many women receive either no pharmacological treatment or are recommended therapies for which fetal safety and efficacy have not been established. First-line treatment of NVP, as recommended by several leading healthcare and professional organizations, is the combination of doxylamine and pyridoxine. This combination, formulated as a 10 mg/10 mg delayed-release tablet, was approved by the US Food and Drug Administration (FDA) for the treatment of NVP in April 2013 under the brand name Diclegis(®), and has been on the Canadian market since 1979, currently under the brand name Diclectin(®). The efficacy of Diclegis(®)/Diclectin(®) has been demonstrated in several clinical trials, and, more importantly, studies on more than 200,000 women exposed to doxylamine and pyridoxine in the first trimester of pregnancy have demonstrated no increased fetal risk for congenital malformations and other adverse pregnancy outcomes. The present review aims to present the scientific evidence on the effectiveness and fetal safety of Diclegis(®)/Diclectin(®) for the treatment of NVP to justify its use as first-line treatment for NVP.
Topics: Antiemetics; Delayed-Action Preparations; Dicyclomine; Doxylamine; Drug Combinations; Female; Humans; Nausea; Pregnancy; Pregnancy Complications; Pyridoxine; Treatment Outcome; Vomiting
PubMed: 24574047
DOI: 10.1007/s40272-014-0065-5 -
Hospital Pharmacy Jul 2013Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The...
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The July 2013 monograph topics are prothrombin complex concentrate (human), cysteamine bitartrate delayed-release capsules, doxylamine succinate/pyridoxine hydrochloride, tedizolid phosphate, and sofosbuvir. The DUE/MUE is on canaglifozin.
PubMed: 24421524
DOI: 10.1310/hpj4807-580 -
Geburtshilfe Und Frauenheilkunde Feb 2024Nausea and vomiting of pregnancy (NVP) is among the most common conditions that pregnant women encounter in the early stages of pregnancy. It can affect up to 85% of...
Nausea and vomiting of pregnancy (NVP) is among the most common conditions that pregnant women encounter in the early stages of pregnancy. It can affect up to 85% of pregnant women, thus representing a significant public health concern. NVP results in substantial negative physical, emotional, and financial consequences. Despite its prevalence, the pathogenesis remains elusive. Few guidelines have been published; however, several interventions exist for the symptomatic treatment of NVP. The aim of this review is to provide an overview of modern treatment strategies of NVP with a special focus on the recently approved dual-release formulation of the doxylamine and pyridoxine combination. This combination was approved by the Food and Drug Administration (FDA) in November 2016 for the treatment of NVP when conservative management fails, and it has been introduced to the American market in April 2018. The maximum plasma concentration (T ) of doxylamine and pyridoxal-5-phosphate is reached 3.5 h and 15 h, respectively, after administration of one tablet twice daily, or 4.5 h and 0.5 h, respectively, when one tablet is administered just once daily. In addition, the delayed-release combination allows sufficient levels of doxylamine and the active metabolite pyridoxal-5-phosphate in the systemic circulation, providing symptoms relief in the subsequent morning. Hence, the dual-release formulation can improve the quality of life of pregnant women suffering from NVP. Additionally, large epidemiological trials have shown no increased risk of adverse effects to newborns, demonstrating that its use is not teratogenic.
PubMed: 38344043
DOI: 10.1055/a-2225-5883 -
The Journal of the American Board of... 2004Ten percent to 40% of adults have intermittent insomnia, and 15% have long-term sleep difficulties. This article provides a review of the classification, differential... (Review)
Review
Ten percent to 40% of adults have intermittent insomnia, and 15% have long-term sleep difficulties. This article provides a review of the classification, differential diagnosis, and treatment options available for insomnia. We performed a MEDLINE search using OVID and the key words "insomnia," "sleeplessness," "behavior modification," "herbs," "medicinal," and "pharmacologic therapy." Articles were selected based on their relevance to the topic. Evaluation of insomnia includes a careful sleep history, review of medical history, review of medication use (including over-the-counter and herbal medications), family history, and screening for depression, anxiety, and substance abuse. Treatment should be individualized based on the nature and severity of symptoms. Nonpharmacologic treatments are effective and have minimal side effects compared with drug therapies. Medications such as diphenhydramine, doxylamine, and trazodone can be used initially, but patients may not tolerate their side effects. Newer medications such as zolpidem and zaleplon have short half-lives and minimal side effects. Both are approved for short-term use in the insomniac.
Topics: Algorithms; Benzodiazepines; Complementary Therapies; Humans; Hypnotics and Sedatives; Psychotherapy; Sleep Initiation and Maintenance Disorders
PubMed: 15226287
DOI: 10.3122/jabfm.17.3.212 -
American Family Physician Nov 2018Women often see their primary care physicians for common acute conditions during pregnancy. These conditions may be caused by pregnancy (obstetric problems) or worsened... (Review)
Review
Women often see their primary care physicians for common acute conditions during pregnancy. These conditions may be caused by pregnancy (obstetric problems) or worsened by pregnancy (obstetrically aggravated problems), or they may require special consideration during pregnancy because of maternal or fetal risks (nonobstetric problems). Primary care physicians should know the differential diagnosis for common conditions during pregnancy and recognize the important findings of obstetric and urgent nonobstetric problems. The family physician can evaluate and treat most nonobstetric problems, although obstetric problems require referral to a primary maternity care clinician. A tiered approach, including routinely looking for all-cause red flag symptoms and signs, while remaining aware of estimated gestational age, allows for high-quality care and shared decision making between the family physician and the pregnant patient. When treating common causes of nausea and epigastric pain/gastroesophageal reflux, lifestyle modifications are considered the safest and first-choice therapy, followed by well-established low-risk therapies, such as vitamin B6 (pyridoxine) and doxylamine for nausea, and antacids not containing salicylates (found in bismuth combination products) for gastroesophageal reflux. Other common conditions during pregnancy are best treated with low-risk therapies, such as using antihistamines or topical steroids for rashes, first-generation cephalosporins or amoxicillin for cystitis, and physical therapy and acetaminophen for low back pain and headaches.
Topics: Acute Disease; Diagnosis, Differential; Female; Humans; Pregnancy; Pregnancy Complications; Primary Health Care
PubMed: 30325641
DOI: No ID Found -
Maedica Dec 2020Prescribing drugs in pregnancy is a challenging approach for doctors. To evaluate drugs used in pregnancy. A prospective, cross-sectional, descriptive study was carried...
Prescribing drugs in pregnancy is a challenging approach for doctors. To evaluate drugs used in pregnancy. A prospective, cross-sectional, descriptive study was carried out by collecting and evaluating prescriptions on various parameters. More than 50% of antenatal care attendees belonged to the 18-24 age group, and 102 (41.46%) were primigravidae. The main presenting complaints were abdominal pain (25.16%), followed by nausea and vomiting (22.60%) and fever (11.14%); the maximum number of visits to hospital was seen in the first trimester (40.53%), followed by the third trimester (38.42%). It was observed that 25.78% of prescriptions did not contain any medicine. The average number of prescribed medicines was 2.32, with the lowest in the first trimester (1.77) and the highest in the second trimester (2.78). It was noticed that 74.11% and 71.26% of all prescribed medicines were from essential medicine list and generics, respectively. Of all prescribed drugs, 11.52% were antimicrobials, and 4.11% injectable dosage forms. Vitamins and minerals were the preferred prescribed medicines (34.82%), followed by antimicrobial agents (11.52%) and doxylamine plus pyridoxine (10.16%). Also, doctors who made the drug choice during antenatal visits were more confident in evidence-based safety as per New Pregnancy and Lactation Rule (PPLR); 45.37% of drugs were prescribed from category A, followed by 38.25% from category B and none from group X. Doctors were concerned about prescribing safer drugs in pregnancy and were more confident in evidence-based medication.
PubMed: 33603908
DOI: 10.26574/maedica.2020.15.4.503