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Nausea and Vomiting of Pregnancy (NVP)

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Nausea and Vomiting of Pregnancy (NVP) Management of Nausea and Vomiting of Pregnancy after Discharge from the Emergency Department Cathy Yeulet/Thinkstock.com ausea and vomiting of pregnancy (NVP) is a common condition that affects N almost 70% of women in the US and globally.1,2 Patients with NVP present with nausea and vomiting with or without retching, usually before 9 weeks of gestation.3,4 Secondary symptoms of NVP can include excessive salivation or a bitter/metallic taste in the mouth. Abdominal pain, fever, and headache are not usually seen. Pa- tients who present to the emergency department (ED) will likely have more severe symptoms and may have already sought treatment as an outpatient from their pri- mary care provider or obstetrician. The most severe form of NVP is hyperemesis gravidarum (HG), which affects approximately 1.2% of women and often leads to hospitalization.1 Those who have progressed to HG may additionally present with signs of acute starvation, weight loss, ketonuria, electrolyte imbalance, and liver, kidney, and thyroid abnormalities. Publication of this supplement is made possible through a restricted grant from Duchesnay USA. This supplement is also available on www.EM-News.com. LWW-EMN_May 2016_Supplement_Sample.indd 1 07/04/16 3:55 PM The total cost of treating NVP in the US was more or vomiting in hospitalized patients with HG.7 In the than $1.7 billion in 2012, including the direct cost of absence of evidence-based guidelines or evidence of healthcare and indirect costs associated with lost work superior efficacy, the choice of antiemetic medication or the need for additional caregivers in the home.5 The in the ED for acute treatment of NVP should take more than 240,000 ED visits for NVP and HG in 2012 into account the severity of symptoms, patient status, were estimated to cost approximately $250 million.5 and the safety of each medication, carefully weighed Total medical care costs increased with the severity of against the potential benefits.3 NVP symptoms and the use of second- and third-line Hospital admission is reserved for the most severe medications such as metoclopramide and ondanse- forms of NVP. Hospitalization for treatment and obser- tron.5 Effective treatment of NVP in the ED and at vation is recommended for patients who cannot tolerate discharge is critical to reduce symptom progression oral liquids without vomiting, do not respond to anti- and the number of repeat ED visits or hospitalization emetic medication, and continue to lose weight.3 for severe NVP or HG, thereby reducing the cost of care.3 Discharge Therapy for NVP Once a patient’s symptoms have been stabilized in the Treatment of NVP in the ED ED, a decision must be made about post-discharge in- Overall, the goals of NVP treatment are to reduce the structions to control NVP symptoms at home. These severity and impact of symptoms, and to reduce the instructions may include dietary and lifestyle recom- risk of progression to more severe NVP or HG while mendations, non-pharmacologic approaches, and phar- minimizing any adverse effects of treatment on the macologic therapies. fetus. The immediate priorities for a woman present- Patients may have already attempted to reduce NVP ing to the ED with NVP are to replace fluids if the symptoms with dietary or lifestyle changes prior to their patient is dehydrated, using intravenous (IV) hydra- ED visit, and they should be encouraged to continue tion, and to correct ketosis and vitamin deficiency.3 these practices to help keep symptoms under control.3,8 Thiamine may be needed to prevent Wernicke en- Non-pharmacologic options include pyridoxine (vita- cephalopathy. It is also important to determine which min B6) and ginger,9-11 though these may not be suitable therapies the patient has already tried to control her for women who initially presented to the ED with mod- NVP symptoms, including dietary or lifestyle changes, erate to severe symptoms. herbal remedies, or over-the-counter treatments, as Women may be cautious about taking medication for well as any prescription medications. NVP out of concern for the potential effects on the Intravenous (IV) or oral pharmacotherapy may be fetus.8,12 As with acute treatment in the ED, the choice used to reduce nausea and vomiting in the ED. It is of antiemetic to prescribe at discharge should take into important to note that no studies have compared the account all available data on maternal and fetal safety, efficacy of antiemetic medications used for treatment weighed against the benefits of treatment. Decisions of acute symptoms of NVP in the ED, and there are about antiemetic medications for NVP prescribed at no evidence-based guidelines for the emergency treat- discharge can be guided by evidence-based recommen- ment of NVP. A recent retrospective study of 439 dations from the American College of Obstetricians women with NVP who were treated in the ED over a and Gynecologists (ACOG).3,13 The use of ACOG period of two years evaluated the time from treatment guidelines for treatment decision-making at ED dis- administration to ED discharge as a proxy for treat- charge will facilitate continuity of care with the patient’s ment efficacy.6 Patients were given ondansetron (48%), obstetrician or primary care provider, and may produce metoclopramide (38%), prochlorperazine (1%), or better outcomes for women with NVP and reduce the promethazine (13%), and 9% of patients were given risk of repeat ED visits or hospitalization. more than one medication. Each medication had a similar mean time from administration to discharge, Delayed-Release Doxylamine/Pyridoxine as suggesting no difference in efficacy for acute manage- First-Line Pharmacotherapy at Discharge ment of NVP in the ED. Another recent randomized ACOG recommends that pyridoxine alone or in combi- controlled trial also found no difference between on- nation with doxylamine (an histamine 1 [H1] receptor dansetron and metoclopramide in reducing nausea blocker) be considered as first-line pharmacotherapy for 2 MAY 2016 LWW-EMN_May 2016_Supplement_Sample.indd 2 07/04/16 3:55 PM the treatment of NVP (Figure).3 A recent matched co- Emergency Department hort study of 160 women with NVP found a greater Acute Management of NVP effect of the combination of doxylamine and pyridox- ine compared with pyridoxine alone for reducing the Discharge symptoms of NVP, particularly in women with moder- ate to severe symptoms.14 In the US, a delayed-release Doxylamine 10 mg/pyridoxine 10 mg delayed-release tabletsa formulation of doxylamine 10 mg and pyridoxine (Pregnancy Category A) 10 mg (marketed as Diclegis®) is currently the only medication approved for use for the treatment of NVP in patients who have not responded to conservative treatment, including dietary and lifestyle changes.15,16 ADD The combination of doxylamine 10 mg/pyridox- Dimenhydrinate (Pregnancy Category B) 50-100 mg every 4-6 hoursb ine 10 mg was available in the US from 1958 to 1983, marketed as Bendectin®. During that time pe- riod, up to 30% of all pregnant women (an estimated 33 million women) received Bendectin for NVP.17 ADD Case reports of teratogenic effects of Bendectin Metoclopramide (Pregnancy Category B) eventually led to its voluntary removal from the US 5-10 mg every 8 hours before breakfast, lunch, dinner, bedtimec market in 1983, despite evidence from several large OR cohort studies and meta-analyses demonstrating the Promethazine (Pregnancy Category C) maternal and fetal safety of doxylamine/pyridox- 12.5-25 mg every 4 hours, orally or rectally ine.18-20 While the removal of Bendectin from the market did not result in a change in the overall num- ber of reported birth defects in the US, as would be Ondansetron (Pregnancy Category B) expected for a teratogen, the number of severe NVP 4-8 mg orally, every 6-8 hours cases resulting in hospitalization doubled.17 In Can- ada, a delayed-release combination of doxylamine 10 mg/pyridoxine 10 mg (Diclectin®) remained on the market and no increases in birth defects have been Methylprednisolone noted. These epidemiological and ecological data pro- (Pregnancy Category C)d vided strong support for the safety and efficacy of 16 mg every 8 hours for 3 days delayed-release doxylamine/pyridoxine for treatment Figure. Pharmacotherapeutic Approach to NVP of NVP, and its return to the US market as Diclegis after Discharge from the Emergency Department: in 2013. Application of American College of Obstetricians 3,34 A phase 3 placebo-controlled study was conducted and Gynecologists (ACOG) Guidelines a If 2 tablets/day, take 2 at bedtime; if 3 tablets/day, take 1 in the in the US as part of the Diclegis New Drug Applica- morning and 2 at bedtime; if 4 tablets/day, take 1 in the morning, tion to the FDA.21 The study included 131 women 1 mid-afternoon, and 2 at bedtime. b Not to exceed 400 mg per day. Not to exceed 200 mg per day if randomized to Diclegis and 125 randomized to pla- patient also is taking doxylamine to reduce sedation effect. cebo who were in weeks 7-14 of pregnancy and were c If frequent vomiting, take 30-45 minutes prior to doxylamine/ pyridoxine. experiencing symptoms of NVP that were not respon- d Corticosteroids are associated with an increased risk of oral clefts sive to dietary or lifestyle changes. Delayed-release when used during the first 10 weeks of gestation, and should be used as a last resort in patients with severe NVP or HG that is not respon- doxylamine/pyridoxine was found to be superior to sive to other medications. After 3 days, taper over 2 weeks to lowest placebo in reducing NVP symptoms, with improve- effective dose.
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