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Biomedical subjects

F W Rosa

Publications and source records attributed to F W Rosa.

At least 19 recordsLinked to original sources
PubMed1992

Effects of exposure to benzodiazepine during fetal life.

Dysmorphism and mental retardation have been reported in 7 Swedish children born of mothers who had taken high doses of benzodiazepines regularly during pregnancy. To explore this association further, we examined benzodiazepine use during pregnancy in 104,000 women whose deliveries were registered by the US public health insurance system, Medicaid, during 1980-83. Fetal outcomes were assessed from the health claims profiles of their offspring, up to 6-9 years after delivery. 80 pregnant women had received 10 or more benzodiazepine prescriptions during the 4 years. Their records showed heavy general use of health care and frequent alcohol and substance abuse, and other disorders that could confound any effect of the benzodiazepines. For the 80 pregnancies, 3 intrauterine deaths were identified as well as 2 infants with congenital abnormalities whose curtailed records suggested neonatal death. Records of 64 surviving children could be linked to these 80 pregnancies whilst records for 11 apparent survivors could not be located. 6 of the 64 survivors had diagnoses consistent with teratogenic abnormalities. The high rate of teratogenicity after heavy maternal benzodiazepine use occurs with multiple alcohol and substance exposure and thus may not be due to benzodiazepine exposure.

Abnormalities, Drug-Induced↗
PubMed1992

Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors.

OBJECTIVE: Case reports of suspected adverse pregnancy outcomes associated with prenatal exposure to angiotensin-converting enzyme inhibitors, particularly oligohydramnios, prolonged neonatal anuria, and defects of ossification of the skull dome, prompted us to examine pregnancy outcome in a large cohort of pregnant women for whom complete drug exposure information was known. METHODS: We studied the prescribed drug exposure histories and pregnancy outcomes of all women aged 15-44 years enrolled in Tennessee Medicaid who delivered a live-born or stillborn infant between January 1, 1983 and December 31, 1988. RESULTS: Of the 106,813 women enrolled in Tennessee Medicaid who delivered either a live-born or stillborn infant during the study period, 19 were exposed to an angiotensin-converting enzyme inhibitor during pregnancy. All 19 women delivered live infants. Among the 19 newborns, one preterm infant had prolonged anuria necessitating dialysis and a second preterm infant had microcephaly and a large occipital encephalocele. CONCLUSIONS: These outcomes represent a systematic follow-up of all angiotensin-converting enzyme inhibitor-exposed pregnancies. Despite the small number of exposures, there were two outcomes previously linked to prenatal use of these drugs, suggesting that the absolute risk may be high. In light of these findings and the case reports of others, it is prudent to avoid the use of angiotensin-converting enzyme inhibitors in pregnancy.

Abnormalities, Drug-Induced↗
PubMed1989

Morbidity and mortality among low birth weight infants exposed to an intravenous vitamin E product, E-Ferol.

In April 1984, the US FDA was notified of an unusual clinical syndrome consisting of ascites, liver and renal failure, thrombocytopenia, and death among low birth weight infants exposed to an intravenous vitamin E preparation, E-Ferol. The product, which had not been tested for safety prior to marketing, was voluntarily withdrawn from the market in early April. To further investigate the reported associations, the FDA conducted a retrospective cohort study among seven neonatal intensive care units where the product had been used. Standardized abstraction forms were completed for infants admitted to a unit between Nov 1, 1983, and April 30, 1984. Included in the study were 379 infants weighing 2,000 g or less and surviving at least two days; 148 (39%) had been exposed to E-Ferol. Compared with the unexposed infants, the exposed infants were more likely to die and to have ascites, hepatomegaly, thrombocytopenia, and a combination of clinical events similar to the syndrome initially reported. We conclude that the use of E-Ferol in these neonatal intensive care units was associated with increased morbidity and mortality among exposed infants.

Acute Kidney Injury↗
PubMed1989

Neonatal anuria with maternal angiotensin-converting enzyme inhibition.

The use of angiotensin-converting enzyme inhibitors as antihypertensives has increased rapidly since the introduction of captopril in 1981. Seven cases of neonatal renal failure have been reported in patients with exposure to angiotensin-converting enzyme inhibitors that continued to the time of delivery. Two cases resulted in death of the newborn; the other five patients recovered after peritoneal dialysis. Because the relative frequency of normal outcomes is unknown, these data are insufficient for incidence-rate estimates or risk/benefit analyses. However, given the potential neonatal morbidity and mortality associated with late-pregnancy exposure to angiotensin-converting enzyme inhibitors, alternative therapies in the third trimester should be given consideration. If these drugs must be used in this context, the clinician should be prepared to deal with renal failure and hypotension in the newborn. The Food and Drug Administration invites reports of adverse pregnancy outcomes associated with such exposure.

Acute Kidney Injury↗
PubMed1987

Pregnancy outcomes after first-trimester vaginitis drug therapy.

Prescription frequencies in the first trimester were compared for miconazole, clotrimazole, nystatin, candicidin, aminacrine compounds, and metronidazole before deliveries involving congenital anomalies versus those not linked to congenital anomalies. Prescriptions before spontaneous abortions were compared with those in the first trimester of deliveries and with those before legal abortions. No statistically significant association was observed with any of these agents for the overall frequency of birth defects or for specific birth defects analyzed (cardiovascular defects, oral clefts, and spina bifida). Two hundred fifty miconazole exposures among 4264 spontaneous abortions, compared with 2236 in the first trimester of 55,736 deliveries, provided an estimated relative risk of 1.4 (95% confidence limits 1.2-1.5). One hundred twelve treatments with clotrimazole among the spontaneous abortions, compared with 1086 among the deliveries, provided a relative risk of 1.4 (95% confidence limits 1.1-1.6). In contrast, large numbers of exposures to nystatin and aminacrine compounds did not show this association, suggesting that spontaneous abortions are caused by the imidazole agents miconazole and clotrimazole rather than the condition being treated. Because many associations were examined without previous hypotheses, and because the data were inadequate to show an elevated risk for clotrimazole when comparing spontaneous with legal abortion exposures, these findings are considered to be a signal for further studies rather than definitive in themselves.

Abnormalities, Drug-Induced↗
PubMed1986

Teratogen update: vitamin A congeners.

Despite animal vitamin A congener teratogenicity in animal studies since 1954, striking human findings only arose in 1983 following isotretinoin (ITR) marketing for oral treatment of severe acne. By November 1985, 44 outcomes with central nervous system (CNS), cardioaortic (CV), microtia, facial palsy, micrognathia, cleft palate, and/or thymic aplasia defects, and 33 spontaneous abortions have been reported. The critical period for exposure appears to be two to five weeks postconception, although this is clinically inexact. ITR half life is less than a day, although a teratogenic metabolite, 4-oxo-isoretinoin, has a half life of several days. Seven defect outcomes and one stillbirth have been reported with another congener, etretinate (ETR), used for psoriasis. Three of these had meningomyeloceles. Half life of several months makes levels cumulative. Only one additional defect, which may have occurred by chance, is reported with use stopped before conception (4 months). Other discontinuations 1 to 6 months before conception had 11 normal outcomes and two spontaneous abortions. ITR and ETR dose ranged from 0.5 to 1.5 mg/kg. Normal outcomes are reported both with ITR and ETR, but some of these appear not to have been exposed during the critical period. Less striking defects, abortions, and normal outcomes are less well reported. Because vitamin A analogs are therapeutically important and unplanned outcome not always avoidable, further animal research is needed for better risk/benefits. Megadose vitamin A (retinol) use is widespread, but experience poorly observed. Eighteen suspicious birth defect outcomes have been reported from pregnancies with high dose exposure. Twelve had findings similar to those seen in animals and in human retinoid syndromes, e.g., CNS, CV, microtia, and clefts. Epidemiological controls are lacking to establish human teratogenicity, but based on animal studies and experience with ITR and ETR, avoiding long term megadose Vitamin A use in fertile women is warranted.

Abnormalities, Drug-Induced↗
PubMed1984

The effect of immune globulin on the response to trivalent oral poliovirus and yellow fever vaccinations.

To assess whether immune globulin may be administered concurrently with trivalent oral poliovirus vaccine (OPV) or yellow fever vaccine, antibody responses were studied in Peace Corps volunteers embarking for overseas duty in 1978. Of 200 volunteers who received OPV, 192 (96%) had pre-existing neutralizing antibody to at least 2 poliovirus types; of 160 yellow fever vaccinees, 24 (15%) had pre-existing 17D yellow fever antibody. Each volunteer received 5 ml of immune globulin, 0-7 days before, 3-5 days after, or 28-32 days after vaccination. This last group was designated the control group. Of the volunteers who received immune globulin 0-7 days before vaccination, 71% 72%, 49%, and 82% responded to poliovirus types 1, 2, and 3, and yellow fever, respectively (response was defined as a 4-fold or greater rise in serum neutralizing antibody titre between baseline (0-7 days before vaccination) and follow-up (15-40 days after vaccination)). These rates did not differ significantly from those in persons who received immune globulin 28-32 days after vaccination (61%, 60%, 51%, and 83%, respectively). Thus, among individuals who, for the most part, were immune to poliomyelitis but not to yellow fever, immune globulin did not decrease the antibody response to OPV or to yellow fever vaccine when given 0-7 days before vaccination.

Administration, Oral↗
PubMed1983

Relationship of oral contraceptive estrogen dose to age.

The authors analyzed extracts of the computerized Medicaid records of 81,968 patients with prescription billing claims for oral contraceptives from the states of Michigan and Minnesota in 1980. It was found that women aged 35-39 years were more than twice as likely to be recipients of high dose (over 50 micrograms) estrogen oral contraceptive preparations than women aged 15-19. There was an increase in the proportion of high dose estrogen recipients among oral contraceptive recipients for each successive five-year age group from 15-19 to 35-39 years in both states. These findings were similar to those from National Disease and Therapeutic Index data for the United States for 1980, and appear to indicate changing patterns of use in the past decade. The independent contributions of age and estrogen dose or their combined effect with respect to the risk for venous thrombosis, pulmonary embolism, or related diseases has not been assessed in prior studies. To the extent that current use of oral contraceptives with higher estrogen doses contributes to the age-related trend of morbidity and mortality rates among women aged 15-44 years, an opportunity for prevention exists by altering this pattern of use.

Adolescent↗
PubMed1983

Pre-exposure prophylaxis in Peace Corps volunteers with intradermal human diploid cell rabies vaccine.

The Peace Corps has had approximately 60 000 person/years of experience with rabies pre-exposure duck embryo vaccine (DEV) immunizations, which are required in 80% of volunteer assignments. Rabies exposure treatment rate is much higher in these areas than in the United States. One death from rabies has occurred despite pre-exposure injections. One death also occurred from serum hepatitis contracted in local emergency management of an anaphylactic reaction to duck embryo vaccine. A query to the Peace Corps field medical offices obtained reports of 21 serious reactions in approximately 8000 duck embryo immunizations. Two thirds of the reactions occurred with the first injection. Only a third of titres measured after four injections of DEV achieved a protective level of greater than or equal to 1:16. Because of these problems human diploid intracellular vaccine (HDCV) was studied in areas where it was available. Because of the high cost and initial short supply, intradermal injections of 0.1 ml HDCV were given. 567 of 570 persons achieved adequate titres. No systemic reactions were reported with intradermal HDCV.

Developing Countries↗