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Biomedical subjects

S S Jick

Publications and source records attributed to S S Jick.

52 records · Page 3Linked to original sources

The incidence of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. A population-based study with particular reference to reactions caused by drugs among outpatients.

We carried out a study to estimate the incidence of erythema multiforme (EM), Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) requiring hospitalization and to determine which drug therapies were associated with these reactions. We reviewed the clinical records of all patients who were hospitalized with these discharge diagnoses at Group Health Cooperative (GHC) of Puget Sound, Seattle, Wash, from 1972 through 1986. During this 14-year period, an average of about 260,000 persons, with demographic characteristics similar to those of the general population, received their care from GHC, and there were about 25,000 admissions to hospitals per year at the GHC hospitals. Based on International Classification of Diseases-Adapted coding, a total of 61 suspect cases of EM, SJS, or TEN were identified from the computerized hospital discharge file. Based on record review and the application of a uniform set of diagnostic criteria, a total of 37 patients (61%) were classified as having EM, SJS, or TEN. Of these, 16 cases (43%) were attributed to drugs administered to these patients prior to hospitalization. The overall incidence of hospitalization for EM, SJS, or TEN due to all causes was 4.2 per 10(6) person-years. The incidence of TEN alone due to all causes was 0.5 per 10(6) person-years. The incidence of EM, SJS, or TEN associated with drug use were 7.0, 1.8, and 9.0 per 10(6) person-years, respectively, for persons younger than 20 years of age, 20 to 64 years of age, and 65 years of age and older. Drug therapies with reaction rates in excess of 1 per 100,000 exposed individuals include phenobarbital (20 per 100,000), nitrofurantoin (7 per 100,000), sulfamethoxazole and trimethoprim, and ampicillin (both 3 per 100,000), and amoxicillin (2 per 100,000). Overall, our data suggest that cases of EM, SJS, and TEN sufficiently severe to require hospitalization are infrequent among outpatients using well-established drug therapies. A continuing challenge is the evaluation of these severe cutaneous reactions that are associated with newly marketed or less frequently prescribed drug therapies.

Adolescent↗

Multivitamin/folic acid supplementation in early pregnancy reduces the prevalence of neural tube defects.

We examined the relation of multivitamin intake in general, and folic acid in particular, to the risk of neural tube defects in a cohort of 23,491 women undergoing maternal serum alpha-fetoprotein screening or amniocentesis around 16 weeks of gestation. Complete questionnaires and subsequent pregnancy outcome information was obtained in 22,776 pregnancies, 49 of which ended in a neural tube defect. The prevalence of neural tube defect was 3.5 per 1000 among women who never used multivitamins before or after conception or who used multivitamins before conception only. The prevalence of neural tube defects for women who used folic acid-containing multivitamins during the first 6 weeks of pregnancy was substantially lower--0.9 per 1000 (prevalence ratio, 0.27; 95% confidence interval, 0.12 to 0.59 compared with never users). For women who used multivitamins without folic acid during the first 6 weeks of pregnancy and women who used multivitamins containing folic acid beginning after 7 or more weeks of pregnancy, the prevalences were similar to that of the nonusers and the prevalence ratios were close to 1.0.

Adult↗

Follow-up study of tolmetin users.

A follow-up study of 8370 outpatients who filled over 24,000 prescriptions for tolmetin revealed no hospital admissions for acute allergic, blood, skin, or central nervous system illness within 90 days of filling a prescription or refill for the drug. There were two cases of liver disease and two cases of nephrotic syndrome in which an etiologic relationship to tolmetin seemed unlikely but could not be entirely ruled out. In addition, 11 patients were hospitalized for peptic ulcer disease and its complications. In all but two patients other risk factors were present that could readily explain the illness. The rate of hospitalization for peptic ulcer disease and its complications among tolmetin recipients appears to be of the same magnitude as that in patients who take other nonsteroidal antiinflammatory drugs in this population, and close to that of the population at large.

Adult↗

A comparison of wax matrix and microencapsulated potassium chloride in relation to upper gastrointestinal illness requiring hospitalization.

The frequency of hospitalization for documented upper gastrointestinal illness among recipients of either wax matrix or microencapsulated potassium chloride was similar in a study in which clinics were randomly assigned to dispense one or the other preparation. The results indicate that there is no material difference between the two preparations in relation to serious upper gastrointestinal illness.

Adult↗

Predictive values, relative risks, and overall benefits of high and low maternal serum alpha-fetoprotein screening in singleton pregnancies: new epidemiologic data.

In a prospective study of maternal serum alpha-fetoprotein screening for both high and low values, we assessed the overall predictive value, sensitivity, specificity and relative risks for congenital defects and complications of pregnancy. Among 13,486 women with singleton pregnancies interviewed at the time of screening (15 to 20 weeks of gestation), 3.9% had high and 3.4% had low values. A high maternal serum alpha-fetoprotein value was associated with the following adverse outcomes: neural tube defects (relative risk = 224), other major congenital defects (relative risk = 4.7), fetal deaths (relative risk = 8.1), neonatal death (relative risk = 4.7), low birth weight (relative risk = 4.0), newborn complications (relative risk = 3.6), oligohydramnios (relative risk = 3.4), abruptio placentae (relative risk = 3.0) and preeclamptic toxemia (relative risk = 2.3). A low maternal serum alpha-fetoprotein value was associated with chromosomal defects (relative risk = 11.6) for fetal death (relative risk = 3.3). Either high or low maternal serum alpha-fetoprotein values were associated with 34.2% of all major congenital defects, 19.1% of all stillbirths and fetal-neonatal deaths, 11.0% of major pregnancy complications, and 15.9% of serious newborn complications. Maternal serum alpha-fetoprotein screening provides an important adjunctive tool for the identification of high-risk pregnancy and adverse neonatal outcome.

Adolescent↗

Oral contraceptives and breast cancer.

A population-based case-control study of oral contraceptive use and breast cancer was carried out among young women (less than 43 years of age) at Group Health Cooperative of Puget Sound, Seattle, Washington. Use of oral contraceptives before first pregnancy did not materially differ between cases or controls. The rate ratio estimate of breast cancer incidence in women who had used oral contraceptives before first pregnancy compared to those who had not was 0.9 (95% CI = 0.4, 2.1). There were no meaningful patterns of association between breast cancer and duration of use or formulation of oral contraceptive used before first pregnancy.

Adult↗

Hospitalizations for pulmonary reactions following nitrofurantoin use.

Acute pulmonary illness compatible with previously described nitrofurantoin toxicity and requiring hospitalization occurred three times among 16,101 first courses of therapy with nitrofurantoin. One case of fatal pulmonary fibrosis was ascribed to long-term use of nitrofurantoin among 742 observed recipients of ten or more prescriptions.

Acute Disease↗

Non-steroidal anti-inflammatory drugs and hospital admission for perforated peptic ulcer.

The frequency of hospital admission for perforated ulcer was not measurably affected by concurrent use of non-steroidal anti-inflammatory drugs (NSAID) during nearly 30 million person-days of NSAID use at Group Health Cooperative of Puget Sound. Whether patients had ever used cimetidine or antacids, drugs which indicate the presence of ulcer disease or symptoms, was strongly predictive of perforation in the same population (rate ratio 5.1; 95% CI 2.6-10.0). Perforation rates increased sharply with age but were similar for men and women.

Adolescent↗

Conjugated estrogens and fibrocystic breast disease.

The association between replacement estrogen use and subsequent development of fibrocystic breast disease was studied at Group Health Cooperative of Puget Sound. Included were 142 women aged 50-64 years diagnosed by biopsy as having fibrocystic breast disease during the years 1978 through 1983. The relative incidence of hospitalization for estrogen users compared with non-users was 1.9 (95% confidence interval 1.3-2.7). The association became stronger with increasing duration of estrogen use.

Estrogens, Conjugated (USP)↗

A follow-up safety study of ciprofloxacin users.

We followed 37,233 outpatients for 45 days after receiving a prescription for ciprofloxacin to identify any newly diagnosed, important illnesses that might have been caused by the drug. For 29 users the role of ciprofloxacin in the etiology of the illness could not be confidently ruled out (7.79/10,000 persons; 95% CI 5.42-11.18). In only seven was a causal relation to ciprofloxacin considered likely: three skin reactions and one case each of thrombocytopenia, "headache, nausea, and shakes," hallucinations, and palpitations. No fatal illnesses occurred, and all patients recovered after discontinuing the drug. In addition, few cases of photosensitivity were associated with the agent. We conclude that important adverse reactions attributable to ciprofloxacin are uncommon.

Central Nervous System Diseases↗

Nonsteroidal antiinflammatory drugs and certain rare, serious adverse events: a cohort study.

We performed a population-based study of over 100,000 users of diclofenac, naproxen, or piroxicam to identify cases of important blood, skin, central nervous system, kidney, pancreas, or pulmonary disorders caused by these drugs. In three cases a causal relation seemed likely; one of hemolytic anemia attributed to diclofenac, one of neutropenia attributed to naproxen, and one of pancreatitis attributed to piroxicam. In 13 additional cases a causal connection seemed unlikely but could not be fully ruled out. We conclude that such illnesses are uncommonly caused by the three agents studied.

Adult↗

A study of danazol's safety.

In a review of medical records of 530 recipients of danazol at Group Health Cooperative of Puget Sound, we identified 154 (29%) people who reported at least one adverse event that occurred within 45 days after receiving the drug. In no patient did the event require hospitalization, and there were no known long-term sequelae.

Adult↗

Anticonvulsants and congenital malformations.

Earlier studies indicated that the prevalence of congenital anomalies is greater in infants of epileptic mothers treated with anticonvulsants than in infants of mothers without epilepsy. We carried out a study of women in the General Practice Research Database who delivered liveborn infants between January 1988 and March 1993 and who were exposed to an anticonvulsant drug during the first trimester of pregnancy, and women with epilepsy not treated with anticonvulsants during pregnancy. We matched two nonexposed women without epilepsy to each exposed woman for age at delivery, date of baby's birth, and general practice. Two hundred ninety-seven women treated for epilepsy had 10 liveborn infants with major anomalies (3.4%) compared with 6 of the 594 nonexposed women (1.0%, RR = 3.3, 95% CI 1.2-9.2). We conclude that the infants of women with epilepsy who are treated with an anticonvulsant during the first trimester of pregnancy have an increased risk of major congenital anomalies.

Abnormalities, Drug-Induced↗