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Re: Echinococcal cyst in pregnancyFrom: Elrod, Darryl G MAJ 48 MDOS/SGOBO (Darryl.elrod@LAKENHEATH.AF.MIL)Tue Feb 28 15:43:18 2006
She is native of K...stan (sorry to offend, but its one of the former Soviet Union coutries). Per the radiologist these cysts can be present for years and grow at a rate of about 1cm per year. I wouldn't be hell bent to treat her except that she ruptured the thing and proceeded to move down the road to being septic. From what I've read, surgery isn't often a total cure for the disease. The Reprotox info on both of these drugs does list is included here to review. For both drugs, at least this source is saying that there is no substantial risk for congenital anomalies especially out of the first trimester. Am I reading this data right then? I can't figure, assuming what we saw was truly Echinococcal cysts in the liver that had indeed ruptured, what our other options are for her. Glen REPROTOX(r) MEBENDAZOLE Quick take: In spite of concern generated from experimental animal studies, human reports do not suggest that mebendazole increases the risk of congenital anomalies. * * * Mebendazole is an anthelminthic agent, often used in the treatment of pinworms. The addition of mebendazole to the food of a mouse breeding colony caused a high incidence of kinky tails (1). Single 10 mg/kg doses of mebendazole caused teratogenic and embryotoxic effects in pregnant rats (1,2). At higher doses, 100% of the fetal rats exposed to this drug developed abnormally (2,3). The p- fluoroderivative of mebendazole, flubendazole, was also associated with a variety of congenital malformations when it was tested in rats (4). There is a case report of a child born with malformations involving the heart, brain, and face following first trimester exposure to mebendazole (5). In four women with trichinosis, two, who received first trimester treatment with mebendazole and corticosteroids, had miscarriages, but the role the disease may have played in these abortions was not known (6). This and other reports have also described healthy births after mebendazole administration (6,7). In a collection of reports by a British manufacturer of 347 exposed pregnancies, of which 165 cases were evaluated in detail, 7 children were born with anomalies. These included 1 case each of cleft palate, esophageal atresia with imperforate anus, clubfoot, and hypospadias. There were also 3 cases of hemangiomas, one of which was associated with absence of three fingers (P McElhatton, personal communication). The random nature of the reported defects does not suggest an association with mebendazole exposure. A retrospective cross-sectional study in Sri Lanka did not uncover a significant increase in congenital defects in the offspring of women who took mebendazole during pregnancy (in comparison with the incidence of defects in an unexposed, control population) (11). Although not significantly elevated, the incidence of congenital defects among the 407 women who used mebendazole during the first trimester was numerically higher than that found among unexposed women, leading the authors to suggest that the use of mebendazole is best limited to the 2nd and 3rd trimesters of gestation. Follow-up of 192 pregnant women who called a teratology information service with concerns about having taking mebendazole in pregnancy showed 5 of 150 continuing pregnancies to give rise to fetuses or children with malformations (12). This rate was not different from that in a comparison group of women who called with concerns about exposures not believed to be harmful. The malformations included one case each of lung hypoplasia, unilateral renal aplasia, and ventricular septal defect, and two cases of hydronephrosis. Information on outcome was obtained from the mother; systematic evaluation of all children was apparently not performed. In clinical commentaries, the use of mebendazole during the second and third trimesters of pregnancy has been recommended for the elimination of chronic helminth infections that cause maternal anemia (13,14). Mebendazole is poorly absorbed from gut and excreted in extremely small amounts in breast milk (8,9). The oral dose to a baby has been estimated at 1 ng/mL (8). One investigator has suggested that mebendazole administration during lactation may inhibit milk production (10). This observation was based on only one case report. Subsequent reports have questioned this observation and recommend that breastfeeding can continue during mebendazole therapy (8,9 REPROTOX(r) ALBENDAZOLE Albendazole is an anthelminthic marketed as Valbazen and Zental. Albendazole and its metabolites are also formed after administration of the prodrug, netobimin (1). According to one manufacturer (SmithKline Beecham Pharmaceuticals) administration of albendazole with a fatty meal will markedly increase the bioavailability of this drug. Albendazole was teratogenic in rats at a maternal dose of 8.8 mg/kg/d (2) and 10 mg/kg/d (4). In the latter study, teratogenic effects were only detected with histopathologic analysis. Most abnormalities were found in neuroectodermal tissue (4). In the study that utilized netobimin to generate albendazole and its metabolites the defects reported were described only as "external and skeletal" (1). Oral netobimin doses of 50 to 70 mg/kg in the rat on day 10 increased resorptions and defects of the vascular and skeletal systems (7). When administered to pregnant rats only on gestational days 9 to 11, 10 mg/kg/d doses of albendazole did not increase the incidence of fetal defects, but they did decrease crown-rump length in the offspring (8). In this study, reported in abstract, 20 mg/kg/d increased craniofacial and skeletal malformations and produced severe fetotoxicity. In a more detailed report by the same group, albendazole doses of 10 to 30 mg/kg/d were administered to rats on gestational days 10 to 12 (9). Dose-related increases in resorptions and fetal growth retardation were observed. At 20 and 30 mg/kg/d limb bud development was delayed and head and limb defects were increased. The investigators noted distinct interlitter differences in the adverse effects produced by albendazole and suggested that differences in maternal metabolism of this agent may occur (8,9). There were no adverse effects of albendazole at a dosage of 10 or 15 mg/kg on developing embryos or fetuses when administered to pregnant cows at various times in early gestation (5). When tested to detect indications of developmental toxicity using the micromass cell culture method, the presence of albendazole was associated with mitotic arrest in exposed cells (3). Albendazole was believed to produce this effect by interfering with intracellular tubulin organization (3). A brief report described ten cases in which a "high", but unspecified, dose of albendazole had been given to 10 women during their first trimester to treat systemic infections (10). All women went on to deliver normal infants. Because of the reported limb defects in some animal studies and the scarcity of human pregnancy data, one reviewer recommended that albendazole be avoided in the first trimester of pregnancy (11). However, available information is not sufficient to justify termination of a pregnancy if such an exposure does occur. The excretion of albendazole and its major metabolites in milk has been demonstrated in sheep (6). We have been unable to locate references on possible human reproductive or lactation effects of albendazole. //SIGNED// D. Glen Elrod, Maj., USAF, MC Obstetrician/Gynecologist Chief of Obstetrics 48 MDOS/SGOBO RAF Lakenheath, England Telephone DSN: 314-226-8130 Comm: +44 (0) 1638 52 8130 Notice of Confidentiality Under the Privacy Act of 1974, you must safeguard all information reflected on this e-mail and, if applicable, all attachments. Disclosure of information is IAW AFI 33-119, AFI 33-127, AFI 37-131, AFI 37-132, AFI 33-219, and PL 93-579" This e-mail message including any attachments is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. Any questions pertaining to disclosure should be directed to the privacy officer. ________________________________ From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net] On Behalf Of -- ________________________________ GA12L@aol.com Sent: Tuesday, February 28, 2006 8:01 PM To: Multiple recipients of list OB-GYN-L Subject: Re: Echinococcal cyst in pregnancy
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