Disease relevance of Diclectin

• Congenital heart disease in relation to maternal use of Bendectin and other drugs in early pregnancy [1].
• Birth defects related to bendectin use in pregnancy. I. Oral clefts and cardiac defects [2].
• Pyloric stenosis and maternal Bendectin exposure [3].
• Automated pharmacy profiles were examined to determine whether an association between maternal Bendectin use in the first trimester and infantile hypertrophic pyloric stenosis existed [3].
• If needed, Diclectin can be given at doses higher than 4 tablets/day to normalize for body weight or optimize efficacy [4].

High impact information on Diclectin

• Public health issues: bendectin, love canal [5].
• Relative risk estimates (with their 95% confidence limits) for first-trimester exposure to Bendectin were as follows: CP, 0.9 (0.5 to 1.5); CL +/- CP, 0.6 (0.4 to 0.8); and HD, 1.0 (0.6 to 1.6) [2].
• We studied the first-trimester exposure to Bendectin for several major categories of birth defects among infants ascertained through the Metropolitan Atlanta Congenital Defects Program from 1968 to 1978 [6].
• Consideration is given to the issue of risk perception and examples given of risk assessment in practice in Canada for Bendectin, isotretinoin, bovine somatropin (somatotrophin) and oral contraceptives [7].
• In a case-control study spanning five years' experience at Group Health Cooperative of Puget Sound, we could demonstrate no plausible association between the use of spermicides, oral contraceptives, Bendectin, or antibiotics prior to conception and the occurrence of 73 nontraumatic stillbirths [8].

Biological context of Diclectin

• Bendectin and fetal development. A study of Boston City Hospital [9].
• Multivariate analyses examining birth weight, length, head circumference, gestational age, and congenital malformations as dependent variables demonstrated no associations between Bendectin exposure and adverse fetal outcome [9].
• Bendectin was administered orally at doses approximately two, five, and 20 times the human dose equivalent from 22 +/- 2 through 50 days of gestation [10].
• The present study examined the maternal and developmental effects of Bendectin (0, 200, 500, or 800 mg/kg/day, po) administered to timed-pregnant CD rats (36-41/group) during organogenesis (gestational days [gd] 6-15) [11].
• Pharmacokinetics of doxylamine given as Bendectin in the pregnant monkey and baboon [12].

Anatomical context of Diclectin

• The Food and Drug Administration has set the stage for the reintroduction of Bendectin by republishing their conclusion that Bendectin does not represent an increase in reproductive risks to the fetuses of pregnant women [13].
• Except for a possible association of Bendectin with heart valve anomalies (odds ratio = 2.99), we were unable to document other significantly increased risks for congenital malformations [14].

Associations of Diclectin with other chemical compounds

• Some antidotes, however, have no teratogenic risk: atropine (cohort/surveillance studies)+, calcium (oral supplement: cohort study)+ and pyridoxine (Bendectin studies) [15].

Gene context of Diclectin

• Two of the three (microcephaly and cataract) had strong positive associations with vomiting in the absence of Bendectin use [16].

Analytical, diagnostic and therapeutic context of Diclectin

• The objective of this study was to determine the incidence of adverse maternal and fetal effects and pregnancy outcome in 225 women taking Diclectin at the recommended (n = 123) or higher than recommended (n = 102) doses [4].
• Therapeutic modalities discussed in this conference that have been used or are being tested are primarily symptomatic treatments (antihistamines, Bendectin (Merrell Dow; Cincinatti, Ohio), phenothiazines, hypnosis, accupressure, relaxation behavioral modification, audiogenic feedback training, newer medications, diet, and nutritional support) [13].
• These are: unbridled discovery during litigation as exemplified by Bendectin, breast implants and cellular telephones; over zealous privacy laws; and the negative impact of managed care on epidemiologic research [17].
• This meta-analysis provides an estimate of the relative risk of malformation at birth in association with Bendectin exposure [18].
• The embryotoxic and teratogenic potential of Bendectin was assessed in this double-blind study in the cynomolgus monkey (Macaca fascicularis) [10].

References