Safety of oral contraceptives related to steroid content: a critical review.

In 1980, an FDA advisory committee found inconclusive the evidence that the safety of oral contraceptives was related to their steroid content. In 1988, another FDA advisory committee examining the same evidence concluded that there is a trend to suggest such a relationship. The present review critically examines the published evidence and concludes that there is no scientific support for the suggestion that higher-dose oral contraceptives are less safe.

Use of aspartame in pregnancy.

The low-calorie sweetening agent, aspartame, is broken down in the small intestine into three moieties: aspartic acid, methanol and phenylalanine. Acute loading studies have been performed in human beings who received up to six times the 99th percentile of the projected daily intake (6 X 34 = 200 mg/kg). No evidence of risk to the fetus was developed.

Haemostatic mechanisms of the newborn foal: reduced platelet responsiveness.

Whole blood platelet counts, coagulation profiles and in vitro platelet function tests were monitored in newborn foals during the first week of life. Platelet counts, mean platelet volumes and thrombin-induced malondialdehyde production were not different from adult mares. Prothrombin and partial thromboplastin times were slightly, but not significantly, longer for neonatal blood samples than for mare samples.

Breast cancer and oral contraceptives: critique of the proposition that high potency progestogen products confer excess risk.

A recent report by Pike et al. from the U. S.

Incidence of pelvic inflammatory disease in clinical trials with Cu-7 (intrauterine copper contraceptive): a statistical analysis.

Pelvic inflammatory disease (PID) was recorded for 365 of 10,760 women using the Cu-7 for up to 48 months during clinical investigations in the United States. This involved a total exposure of 242,169 woman-months, or some 20,000 woman-years. The overall incidence of PID was 18 cases/1000 woman-years.

Chronobiologic aspects of blood cortisol levels and decay slopes following ethanol administration to adult human subjects.

When single oral doses of ethanol were given to human subjects at different circadian stages on different days, the blood cortisol levels displayed the expected circadian variation and were not significantly affected by the ethanol challenges. When the ethanol was administered repeatedly in a single 24-h experiment, the cortisol levels were variably elevated by these challenges, primarily in the afternoon hours; however, the circadian excursions did not appear to be blocked or markedly phase-shifted. The phase relationships of circadian blood cortisol levels and previously reported blood ethanol decay rates showed individual subject variation.

Zinc deficiency, acrodermatitis enteropathica, optic atrophy, subacute myelo-optic neuropathy, and 5,7-dihalo-8-quinolinols.

Acrodermatitis enteropathica, a heritable disease of zinc deficiency, was formerly amenable to treatment only with dihaloquinolinol drugs. A few cases of optic atrophy were reported in surviving patients and were proposed as examples of ocular drug toxicity, principally because of the association between iodochlorhydroxyquin and subacute myelo-optic neuropathy (SMON) in Japan. An alternate hypothesis is now offered: that the optic atrophy was secondary to the zinc deficiency, which is consistent with diverse evidence cited from the literature.

Chronopharmacokinetics of ethanol. III. Variation in rate of ethanolemia decay in human subjects.

Five male human subjects were administered repeated oral doses of ethanol approximately four hours apart and were examined for venous ethanol levels during the third and fourth hours after each dose. Estimates of the slopes of the apparently linear ethanol disappearance curves exhibited statistically significant variation along a 24-hour time scale within 4 of the 5 subjects, as well as among individuals. Prior findings on one of the subjects were confirmed.

Potencies of oral contraceptives.

Oral contraceptives are combinations of estrogens and progestogens or, in the case of the mini-pills, progestogens alone. With specific test procedures in laboratory animals or human subjects, it is possible to assign potency evaluations to the components relative to the progestational, estrogenic, or antiestrogenic activities of the progestogen or to the estrogenic potencies of the estrogenic component. It might even be possible to quantify the synergistic effects of the estrogen on the progestational agent.

Chronopharmacokinetics of ethanol. I. Review of the literature and theoretical considerations.

Pharmacokinetic parameters are generally assumed to be invariate with the time of day, although circadian variation of drug metabolism and drug response is known. As proposed, chronopharmacokinetics considers the implications of the chronovariability of pharmacokinetic parameters. In order to investigate chronovariation in the rate of disappearance of a substance from the approximate a linear course until very low blood levels are attained.

Chronopharmacokinetics of ethanol. II. Circadian rhythm in rate of blood level decline in a single subject.

A male human subject administered single, oral doses of ethanol was examined repeatedly for venous ethanol levels. Four separate trials, begun at 03.00, 09.