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Home , Doxylamine, Prokinetic agent

March 1, 2008 • www.obgynnews.com 33

Continued from previous page come or congenital anomalies; the only dence-based review of the safety and ef- difference was that the women taking gin- fectiveness of available . They Treatments for tablets were recommended at night, so ger reported more and belching concluded that many medications, partic- one full tablet of Unisom can be taken at (Obstet. Gynecol. 2004;103:639-45). ularly the and pheno- / night, along with a half tablet in the morn- In a literature review, a group of Italian thiazines, are safe and effective for the ing and a half-tablet in the afternoon if investigators identified six double-blind, treatment of varying degrees of nausea Vitamin B6 some nausea persists and, of course, 25 randomized, controlled trials with a total and vomiting (Am. J. Obstet. Gynecol. PremesisRx mg of vitamin B6 at each of these times of 675 participants that met criteria for 2002:186;S256-61). of the day. methodological quality for the evaluation In the same supplement, Dr. Gideon Ko- Antihistamines The combination of vitamin B6 and of efficacy. Of these six trials, four demon- ren addressed the issue of perceived ver- Doxylamine (Unisom) doxylamine can bring fast and dramatic re- strated the superiority of ginger over sus true risk of medications for nausea and (Dramamine) lief for many patients, leading to signifi- placebo, and two demonstrated the equiv- vomiting, and presents an algorithm for (Benadryl) cant improvements in the quality of their alence of ginger with vitamin B6. management that includes a hierarchical (Antivert) lives. There is always concern for obste- To review safety, the investigators use of based on the (Vistaril, Atarax) tricians that a mother will claim that a looked at an observational cohort study in- strength of evidence of fetal safety (Am. (Zyrtec) child’s birth defect was caused by a volving 187 women as well as at the ran- J. Obstet. Gynecol. 2002:186;S248-52). prescribed during the first trimester, but domized trials. The studies showed no sig- Although few studies have compared this is unlikely to happen with the combi- nificant side effects and no adverse effects the antihistamines for nausea and vomit- (Phenergan) nation of vitamin B6 and doxylamine be- on outcome (Obstet. Gynecol. ing in pregnancy, sedation seems to be a (Compazine) cause legal precedents already hold that 2005;105:849). main difference among the various drugs, (Thorazine) the drug does not cause birth defects. Acupuncture is another therapy worthy with some—such as diphenhydramine Interestingly, some studies have sug- of consideration and one that can be (Benadryl)—sedating more than others. In gested that women who have taken mul- added to the treatment regimen at any addition to doxylamine and diphenhy- (Reglan) tivitamins containing vitamin B6 before time. It has now been studied in two ran- dramine, we can consider using dimen- pregnancy have less nausea and vomiting. domized trials in pregnant women who hydrinate (Dramamine), meclizine (An- 5-HT3 Receptor Antagonists had nausea and vomiting, and although tivert), hydroxyzine (Vistaril, Atarax), and (Zofran) Nonpharmacologic Approaches the results do not demonstrate broad ef- cetirizine (Zyrtec). (Anzemet) Ginger ale has been a traditional remedy ficacy, the findings together suggest that If the antihistamines as a class are not (Kytril) for nausea in various populations, and the therapy can be worth a try (Obstet. effective, the phenothiazines are a good among pregnant women with nausea and Gynecol. 2001:97;184-8; J. Symptom choice. Promethazine (Phenergan) is Corticosteroids vomiting, ginger is the alternative thera- Manage. 2000:20;273-9). widely used for nausea and vomiting in py with the strongest evidence base. The Nerve stimulation of the P6 acupunc- pregnancy, and prochlorperazine (Com- Acupuncture data on ginger have accumulated to the ture point also appears to decrease the pazine) and chlorpromazine (Thorazine) point at which concerns about its possible nausea and vomiting of pregnancy for are other options. Ginger adverse effects have largely dissipated, some women, whereas acupressure with Possible adverse side effects of the phe- which makes it worthy of consideration as devices like the Sea-Band or the Bioband nothiazines include sedation, hypotension, a second-line agent. appears to be less effective. dry mouth, and extrapyramidal symp- iting in pregnancy, despite its high cost and Two small, randomized, double-blind toms. Compazine tablets are placed inside the relative paucity of information on its trials used 250-mg ground ginger capsules Antiemetic Drugs the cheek—a formulation that is helpful use in pregnancy. or placebo four times a day, one in 70 out- Ginger and vitamin B6—alone or in com- for women with moderate and severe nau- Several years of use and studies of sev- patients with nausea and vomiting and bination with doxylamine—do not work sea—and are generally well tolerated, with eral hundred patients have increased the one in women who were hospitalized with for everyone. In unsuccessful cases, we can less drowsiness and sedation than the an- comfort level related to ondansetron use. . Investigators of move on to try other antihistamines and, tihistamines. In general, this drug and the an- both trials reported significantly reduced if necessary, to consider the four other cat- The (Inap- tagonists dolasetron (Anzemet) and nausea and reductions in vomiting among egories of antiemetic drugs: phenoth- sine) was popular for some time, but there granisetron (Kytril) are now felt to be the women in the ginger groups (Obstet. iazines, prokinetic agents, serotonin (5- were reports of cardiac deaths and, in safe. All are FDA category B drugs. Gynecol. 2001;97:577-82; Eur. J. Obstet. HT3) antagonists, and corticosteroids. 2001, the FDA issued a black box warning Zofran comes in an oral disintegrating Gynecol. Reprod. Biol. 1990;38:19-24). With the exception of doxylamine, stating that all patients need a 12-lead tablet that, like Compazine, is useful in pa- Among more recent randomized trials which is a Food and Drug Administration ECG before, during, and after adminis- tients who have difficulty swallowing or was one of approximately 300 women category A drug, none are FDA approved tration. This drug has, consequently, fall- who do not feel they are able to drink. In that compared ginger with vitamin B6. for use in pregnancy. The drugs are un- en out of favor. a randomized trial, Zofran was compared Women who received identical-looking derutilized, however, largely because of Metoclopramide (Reglan) can help some with Phenergan and was found to have capsules three times a day of 25 mg vita- misperceptions of teratogenic risk. women when other drugs have failed. It is similar efficacy, but with less sedation. min B6 or 350 mg ginger had similar lev- In a supplement to the American Jour- a prokinetic agent, increasing upper gas- Corticosteroids may not be as beneficial els of improvement in nausea and vomit- nal of Obstetrics and Gynecology on nau- trointestinal motility and lower esophageal as many first thought—there are now con- ing at 1 week, 2 weeks, and 3 weeks. sea and vomiting in pregnancy, Dr. L.A. sphincter tone. A review of Medicaid data flicting data about their effectiveness— There were no differences in fetal out- Magee and associates reported on an evi- showed no increased risk of birth defects and some studies have suggested an in- in 303 newborns in Michigan born to creased risk of cleft lip and palate when D A T A W A T C H mothers who had ingested this drug. these agents are used before 10 weeks’ ges- The serotonin (5-HT3) antagonist on- tation. The drugs are recommended, Percent Change of Live Births to Mothers Under 20 Years Old dansetron (Zofran) has been one of the therefore, only after 10 weeks’ gestation most heavily marketed drugs for postop- and in cases in which other medications –6.3%-0.0% 0.1%-1.5% 1.6%-3.0% 3.1%-5.0% 5.1%-9.9% erative nausea and vomiting, and from the have failed. start many women and their obstetricians Neither I nor any member of my fami- used the drug as a first-line or near-first- ly has any financial connections with the line antiemetic choice for nausea and vom- pharmaceutical industry. ■ M E E T I N G C O V E R A G E San Antonio Breast Cancer Symposium DC Society for Maternal Fetal American Society of Clinical Oncology Genitourinary Cancers Symposium

EWS CDC Advisory Committee on Immunization Practices N Contemporary Forums: Contraceptive Technology EDICAL

M Society of Gynecologic Oncologists Annual Meeting on Women's Cancer Society of Gynecologic Surgeons LOBAL G Society for Obstetric Anesthesia and Perinatology Note: Based on 2005 and preliminary 2006 data. Source: Centers for Disease Control and Prevention

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