Samuel Shapiro

Antenatal exposure to the phenothiazines in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score

In a prospective cohort study of 50,282 gravidas and their offspring, over-all rates of congenital malformations were similar in 1,309 children of women exposed to phenothiazine drugs during the first four lunar months of pregnancy and in 48,973 children of women who were not exposed. There was a suspicion of association between phenothiazine exposure and cardiovascular malformations. In a cohort reduced to 41,337 mother-child pairs for technical reasons, perinatal mortality rates and mean birth weight were similar according to phenothiazine exposure or nonexposure, as were intelligence quotient scores measured at four years of age in 28,358 of the children. Control of potential confounding factors with a variety of multivariate techniques did not materially alter the findings.

Evidence for an Increased Risk of Crohn's Disease in Oral Contraceptive Users

The risk of Crohns disease in relation to oral contraceptive use was evaluated in a hospital-based, case-control study of 57 women with Crohns disease and 2189 controls with other conditions. The relative risk for oral contraceptive users compared with women who had never used these drugs was 1.9 (95% confidence interval 1.0-3.5). The magnitude of the relative risk estimate was related to the timing and duration of oral contraceptive use. For use within the year before admission to a hospital (recent use), the relative risk estimate was 4.3 (2.1-8.7); the estimate dropped to 1.2 (0.5-2.6) 4 yr after discontinuation of oral contraceptive use. The relative risk estimate for recent use that lasted greater than or equal to 5 yr was 8.0 (3.1-21). The findings are in accordance with earlier reports of an increased risk of Crohns disease in oral contraceptive users.

Intrauterine contraceptive device use and pelvic inflammatory disease

We examined the relationship between use of IUDs and PID, based on 44 women who were admitted to hospitals with first episodes of PID and 259 hospital control subjects. All the women used either IUDs or oral contraceptives. The age-adjusted relative risk for those using IUDs at the time of admission was 6.5 (95% confidence interval, 3.2 to 13.0). The association remained when several variables, and particularly parity, were taken into account. There was a suggestion that users who had had an IUD in place for at least 5 years had a higher risk of PID than did users of shorter duration. The data also suggest that copper-containing IUDs may be safer than other devices.

Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Bendectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score

In a prospective cohort study of 20, 282 gravidas and their offspring, congenital malformation rates were similar in the children of over 1,000 women exposed and those not exposed to two components of Bendectin (doxylamine succinate and dicyclomine hydrochloride) during the first four lunar months of pregnancy. In a cohort reduced to 41,337 mother-child pairs for technical reasons, mean birth weight and perinatal mortality rates were similar according to exposure or nonexposure to either drug, as were intelligence quotient scores measured at four years of age in 28,358 of the children. Control of potential confounding factors with a variety of multivariate techniques did not materially alter these findings.

Risk of ovarian cancer according to use of antidepressants, phenothiazines, and benzodiazepines (United States)

AbstractObjectives:An association of increased risk of ovarian cancer with use of antidepressants or benzodiazepine tranquilizers has been reported from a case–control study. We assessed the association between ovarian cancer risk and the use of tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), phenothiazine antipsychotics, and benzodiazepines, in data from the Case–Control Surveillance Study. Methods:From 1976 through 1998, data were collected from hospital patients in Boston, New York, Philadelphia, and Baltimore based on demographic factors, reproductive and medical history, and medication use. In the present analyses, cases of epithelial ovarian cancer (n = 748) were compared with cancer controls (n = 1496) and noncancer controls admitted for trauma and acute infection (n = 1496). We estimated Mantel–Haenszel odds ratios adjusted for age, study center, and year of interview. Results:Odds ratios for regular use (at least 4 days/week for at least 1 month) were compatible with 1.0 for every drug class. For tricyclics and benzodiazepines the upper 95% confidence limits were less than 1.6. For phenothiazines the upper limit was 2.6 with cancer controls and 1.4 with noncancer controls. Only five cases used SSRIs, yielding unstable results. Odds ratios were not increased among women who had used any drug class for at least 5 years, nor among women who had first used them 10 or more years previously. Conclusions:These data do not support an association between regular use of any of the drugs under study with ovarian cancer risk.

Birth defects in relation to Bendectin use in pregnancy. II. Pyloric stenosis.

To test the hypothesis that the use of Bendectin in pregnancy increases the risk of pyloric stenosis, we determined rates of antenatal Bendectin exposure among 325 infants with pyloric stenosis and among two control groups comprising infants with other defects; one consisted of 3,153 infants with other conditions, and the other, a subset of that group, consisted of 724 infants with defects that may have had their origins at any time in pregnancy. Comparisons between the cases and the two control series yielded estimated relative risks of 0.9 (95% confidence interval, 0.6 to 1.2) and 1.0 (0.7 to 1.4), respectively. The findings from this large case-control study suggest that Bendectin does not increase the risk of pyloric stenosis.

Maternal drug exposure and fetal abnormalities. Material and methods.

Data derived from a cohort of 50,897 pregnancies that occurred between 1959 and 1965 are currently being evaluated to determine whether any associations between maternal drug exposure and abnormalities in the offspring exist. In this report, the cohort being studied is briefly described, and the methods used to identify associations, together with factors that confound them, are outlined. Also presented are the techniques used to control for these factors in evaluating the associations. Issues concerning causal interpretation of associations that remain after confounding factors have been controlled are discussed.

Oral Contraceptive Use and Reproductive Risk Factors for Breast Cancer: A Comparison of Results among Black and White Women

Studies of breast cancer have yielded conflicting results on the effects of age at first term birth, parity, and oral contraceptive (OC) use. We assessed these relations separately in black and in white US women aged 25–59 years in a hospital-based case-control study; 524 black cases were compared with 1021 black controls, and 3540 white cases were compared with 4488 white controls. In both racial groups, the risk of breast cancer increased with increasing age at first birth. Multiparity was associated with an increased risk before age 35 in both groups, and a reduced risk in black women aged 35–59 and in white women aged 35–44. OC use was associated with an increased risk among black women under age 45 and among white women under age 35.

Drug Surveillance by Case-Control Methods as Means for Detecting Side-Effects of Oral Contraceptives

In July, 1976, the Drug Epidemiology Unit commenced a large scale system of case-control surveillance designed to provide a data base that among other things could fulfil the following objectives: firstly, the detection of previously unsuspected relationships between specific illnesses and specific drugs; and secondly, the evaluation of existing hypotheses concerning drug/illness relationships. The second objective applies both to hypotheses generated from within the data base itself, and to hypotheses proposed elsewhere.

Medikamenteüberwachung mit Fall-Kontroll-Ansätzen ALS Ein Weg zum Entdecken von Nebenwirkungen Oraler Kontrazeptiva

Die Drug-Epidemiology-Unit begann im Juli 1976 ein grosangelegtes System von Fall-Kontroll-Uberwachung. Dieses System soll die Datenbasis zur Verfugung stellen, um u.a. folgende Ziele zu verfolgen: 1. Die Entdeckung von bis dahin unvermuteten Beziehungen zwischen bestimmten Krankheiten und bestimmten Medikamenten; und 2. die Auswertung bestehender Hypothesen bezuglich Medikament — Krankheit-Beziehungen.