doxylamine/pyridoxine / Generic mfg. - LARVOL DELTA

The Therapeutic Landscape of Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum: Five Decades of Evolving Treatment and Supportive Care. (PubMed, Med Sci (Basel)) - "Keyword and thematic analyses showed a transition from early vomiting, Bendectin, exposure, and pregnancy-safety concerns toward pharmacological treatment, complementary interventions, controlled clinical evaluation, maternal-fetal outcomes, and supportive management. Metadata-completeness analysis identified a major pre-1991 indexing discontinuity, requiring caution when interpreting long-range keyword-based trends. These findings outline the trajectory of the field and highlight priorities for future research, including stronger comparative evidence for pharmacological, complementary, and supportive-care strategies, broader international collaboration, and prospective studies to strengthen the evidence base for managing NVP and HG."

Journal • Review • Gynecology • Obstetrics • Rare Diseases

Comparative Effectiveness of Pharmacological and Non-Pharmacological Interventions for Nausea and Vomiting in Pregnancy: A Systematic Review and Network Meta-Analysis. (PubMed, Nutrients) - "Network analysis ranked quince, vitamin B6 with pomegranate and mint, acupressure P6, dimenhydrinate, and acupuncture combined with doxylamine-pyridoxine as the most effective interventions for reducing symptoms of nausea and vomiting in pregnancy, with considerable uncertainty and low-to-moderate quality of evidence. However, high heterogeneity and sparse reporting of adverse effects warrant caution when translating these results into clinical practice. This study indicates that both pharmacological (vitamin B6, metoclopramide, dimenhydrinate) and non-pharmacological (ginger, quince, acupressure, acupuncture) interventions might be effective in reducing symptoms of nausea and vomiting in pregnancy."

Clinical • HEOR • Journal • Retrospective data • Review • Rare Diseases

Hyperemesis gravidarum revisited: from GDF15 biology to precision multimodal therapy. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "First-line pharmacotherapy includes doxylamine-pyridoxine, followed by dopamine antagonists or 5-HT3 receptor antagonists such as metoclopramide and ondansetron, which demonstrate reassuring safety profiles in large cohort studies. Nutritional support, preferably through enteral tube feeding rather than parenteral nutrition, should be prioritized when oral intake is inadequate. Integrating biological insights with standardized, compassionate, and multidisciplinary care may improve clinical outcomes and reduce the substantial physical and psychological burden associated with HG."

Journal • Review • CNS Disorders • Rare Diseases • GDF15

Nausea and Vomiting in Pregnancy: Prevalence, Clinical Characteristics, and Management Findings from a Prospective Italian Multicenter Cohort Study. (PubMed, Life (Basel)) - "NVP is a common disorder in pregnancy, with a predominance of mild and moderate symptoms. Prior NVP increases the recurrence risk threefold. Despite the high prevalence of NVP, the therapy remains inconsistent and delayed."

Journal • Gynecology • Obstetrics • Rare Diseases

Date Fruit Benefits to Treat Morning Sickness in First Trimester of Pregnancy (clinicaltrials.gov) - P=N/A | N=40 | Active, not recruiting | Sponsor: Bahria University

New trial

Clinical characteristics, management and outcomes of hyperemesis gravidarum: a retrospective study in an Irish maternity hospital. (PubMed, Ir J Med Sci) - "HG significantly impacts maternal health and places demands on hospital resources. While birthweight centiles were generally normal, HG's potential long-term effects on child health warrant further investigation."

Journal • Retrospective data • Obstetrics • Rare Diseases • Small for Gestational Age

Antiemetic use during pregnancy and child neurodevelopment: population-based birth cohort study. (PubMed, BMC Med) - "This large-scale study found no association between antiemetic exposure during pregnancy and the risk of neurodevelopmental disorders or delays in children, providing reassurance for the use of antiemetics in pregnancy to treat nausea and vomiting. However, the slightly elevated risks observed in certain subgroups warrant further investigation. Meanwhile, these findings may assist in guiding decisions when considering antiemetic treatment during pregnancy."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • Cerebral Palsy • CNS Disorders • Developmental Disorders • Epilepsy • Genetic Disorders • Movement Disorders • Pediatrics • Psychiatry

Extrapyramidal Side Effects of Metoclopramide in Pregnancy: A Case of Isolated Lingual Dystonia (EUSEM 2025) - "The patient received intramuscular diphenhydramine 50 mg in the ED, resulting in complete symptom resolution within 30 minutes.She was discharged with instructions to stop metoclopramide and was prescribed Diclectin (pyridoxine with doxylamine) as a safer alternative. This case highlights the importance of recognising atypical presentations of EPSE, such as isolated lingual dystonia. Although metoclopramide is commonly used for nausea and vomiting in pregnancy, clinicians must remain vigilant for medication-induced neurological side effects and prioritise safer alternatives when managing vulnerable populations."

Adverse events • Clinical • CNS Disorders • Dystonia • Endocrine Disorders • Movement Disorders • Myasthenia Gravis • Obstetrics • Psychiatry

Assessing the burden of severe nausea and vomiting of pregnancy or hyperemesis gravidarum and the associated use and experiences of medication treatments: An Australian consumer survey. (PubMed, PLoS One) - "The study findings demonstrate large variability in antiemetic use and outcomes, highlighting the need for individualised care and treatment approaches during pregnancy."

Journal • Anesthesia • CNS Disorders • Constipation • Depression • Gastroenterology • Gastrointestinal Disorder • Mood Disorders • Pain • Psychiatry • Rare Diseases

Hyperemesis in Pregnancy: Complications and Treatment. (PubMed, Med Sci (Basel)) - "HG requires a comprehensive and individualized management approach. While doxylamine-pyridoxine remains the cornerstone of therapy, other pharmacologic and supportive measures may offer additional benefit. Continued research is essential to clarify the underlying mechanisms, improve therapeutic efficacy, and develop evidence-based guidelines that integrate both medical and psychosocial care for affected women."

Journal • Review • Cardiovascular • CNS Disorders • Rare Diseases

Associations of Nausea and Vomiting of Pregnancy with Maternal and Fetal Outcomes. (PubMed, J Clin Med) - "Patients with NVP received pharmacological treatment with doxylamine succinate/pyridoxine hydrochloride...Early pharmacological treatment improves maternal well-being and may reduce hospitalization rates. Larger multicenter studies are needed to confirm these findings."

Journal • Cardiovascular • Diabetes • Gestational Diabetes • Hypertension • Metabolic Disorders • Rare Diseases

The Pharmacological and Clinical Roles of Antiemetics: A Narrative Review. (PubMed, Cureus) - "The present investigation reviews different classes of antiemetics and specific clinical uses for each based on pharmacological action. In addition, a few emerging treatment options are discussed, including cannabinoids, vitamin B6 (pyridoxine), and combination formulations such as Diclegis (doxylamine-pyridoxine), prompting avenues for future roles in the management of emesis."

Journal • Review • Gastroenterology • Gastrointestinal Disorder

Assessing the approaches to nausea and vomiting in pregnancy: insights from a nationwide survey of Italian gynecologists (PURITY light). (PubMed, Front Med (Lausanne)) - "54.78% prescribed medication in mild cases, mainly the doxylamine/pyridoxine combination (64.97%)...Many physicians treat only severe cases of NVP, perceiving it as a transient discomfort, which may lead to poor management. Balanced care is needed to improve the quality of life for pregnant women with NVP."

Journal • Rare Diseases

Changes in doxylamine-pyridoxine dispensation in Ontario following media attention: Time-series analysis. (PubMed, Can Fam Physician) - "Despite nationwide media attention questioning the efficacy of doxylamine-pyridoxine in early 2018, trends in dispensation rates of doxylamine-pyridoxine were only modestly affected and only in Ontario. Within Ontario, a small but significant reduction in doxylamine-pyridoxine dispensations was noted based on prescriptions from family physicians or general practitioners but not based on those written by obstetrician-gynecologists. Factors associated with the ongoing use of doxylamine-pyridoxine despite evidence of lack of benefit require further research."

Journal • Obstetrics

AGA Clinical Practice Update on Pregnancy-Related Gastrointestinal and Liver Disease: Expert Review. (PubMed, Gastroenterology) - "In addition to standard diet and lifestyle measures, stepwise treatment consists of symptom control with vitamin B6 and doxylamine, hydration, and adequate nutrition; ondansetron, metoclopramide, promethazine, and intravenous glucocorticoids may be required in moderate to severe cases...Treatment options include dietary fiber, lactulose, and polyethylene glycol-based laxatives...Biologic agents should be continued throughout pregnancy and the postpartum period; use of methotrexate, thalidomide, and ozanimod must be stopped at least 6 months before conception...Treatment should be offered with oral ursodeoxycholic acid in a total daily dose of 10-15 mg/kg...Daily aspirin prophylaxis for patients at risk for pre-eclampsia or hemolysis, elevated liver enzymes, and low platelets syndrome is advised beginning at week 12 of gestation...Patients not on treatment but with a serum hepatitis B virus DNA level >200,000 IU/mL during the third trimester of pregnancy should be..."

Clinical guideline • Journal • Review • Cholestasis • Constipation • Dermatology • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Gynecology • Hematological Disorders • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Liver Cirrhosis • Pancreatitis • Pruritus • Rare Diseases • Transplantation

Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Valenta Pharm JSC | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ May 2024 | Trial primary completion date: Dec 2024 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date

Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Valenta Pharm JSC

New P1 trial

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy. (PubMed, Ann Intern Med) - No abstract available

Journal

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy. (PubMed, Ann Intern Med) - No abstract available

Journal

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy. (PubMed, Ann Intern Med) - No abstract available

Journal

Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy (clinicaltrials.gov) - P=N/A | N=27 | Completed | Sponsor: Kafrelsheikh University

New trial

Nausea and Vomiting of Pregnancy and its Management with the Dual-Release Formulation of Doxylamine and Pyridoxine. (PubMed, Geburtshilfe Frauenheilkd) - "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."

Journal

The Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum (Green-top Guideline No. 69). (PubMed, BJOG) - "[Grade A] There are safety and efficacy data for first line antiemetics such as anti (H1) histamines, phenothiazines and doxylamine/pyridoxine (Xonvea®) and they should be prescribed initially when required for NVP and HG (Appendix III). [Grade A] There is evidence that ondansetron is safe and effective...[Grade B] Metoclopramide is safe and effective and can be used alone or in combination with other antiemetics...[Grade D] All therapeutic measures should have been tried before considering termination of pregnancy. [Grade C]."

Journal • Rare Diseases

Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers (clinicaltrials.gov) - P=N/A | N=28 | Completed | Sponsor: Valenta Pharm JSC | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Sep 2022 | Trial primary completion date: Dec 2022 ➔ Sep 2022

Trial completion • Trial completion date • Trial primary completion date

"However, in 2019, @CFPJournal published a rather 'interesting' review of Xonvea https://t.co/XQHhBo0HIQ" (,@pash22)

Review