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L J Miwa

Publications and source records attributed to L J Miwa.

13 recordsLinked to original sources
PubMed1997

Value of epidemiologic studies in determining the true incidence of adverse events. The nonsteroidal anti-inflammatory drug story.

BACKGROUND: Evidence supporting differential toxic effects of nonsteroidal anti-inflammatory drugs (NSAIDs) often is derived from spontaneous reports of adverse events to the US Food and Drug Administration (FDA). These reports represent observations from an undefined, exposed population that are not collected in a standardized manner and therefore are subject to reporting biases. Epidemiologic studies, in which the numbers of patients experiencing an adverse event and exposed to the drug are known, provide more reliable measures of risk and can place spontaneous reports in perspective. OBJECTIVE: To compare both data sources with regard to NSAID-associated gastrointestinal, liver, and skin events. METHODS: We obtained spontaneous reports of these adverse events for diclofenac, nabumetone, naproxen, and piroxicam. Published epidemiologic studies of these events were reviewed. RESULTS: Spontaneous reports did not mirror reliably the results of epidemiologic studies. Spontaneous reports showed higher associations of gastrointestinal and skin events with nabumetone and piroxicam and hepatic events with diclofenac. Epidemiologic studies generally did not show differential risk among these NSAIDs. CONCLUSIONS: When the 4 NSAIDs are compared in epidemiologic studies, there is no quantitative basis for identifying 1 as more or less toxic than the others, underlining the hazard of deriving quantitative conclusions from spontaneous reports. Spontaneous reports are an unreliable measure of risk; rather, they may provide evidence of the relative awareness of specific toxic effects among physicians.

Adult↗
PubMed1992

Propafenone associated agranulocytosis.

Propafenone hydrochloride was approved for marketing by the United States (U.S.) Food and Drug Administration (FDA) in November 1989. During U.S. clinical trials of propafenone, one case of agranulocytosis was seen. Seven additional cases have been reported outside the U.S. One German report of profound but reversible granulocytopenia appeared in 1982. In January 1991, the FDA reviewed adverse events reported with propafenone. Four reports of agranulocytosis were identified and are described. The reporting rate of approximately one case of agranulocytosis per 10,000 propafenone prescriptions per year likely underestimates the true incidence of this adverse event.

Aged↗
PubMed1990

Drug-induced hypertrichosis: case report and review of the literature.

Hypertrichosis is a well-recognized adverse effect of therapy with either cyclosporine or minoxidil. We present a case of extreme hypertrichosis in an eight-year-old male liver transplant recipient who received concurrent cyclosporine and minoxidil therapy. A review of drug-induced hypertrichosis is presented.

Child↗
PubMed1990

Sensory/mixability preference evaluation of cholestyramine powder formulations.

This double-blind, crossover trial compared the sensory and product preparation characteristics of two cholestyramine powder preparations. The study involved 100 healthy volunteers, aged 22-65 (mean 42 years). Questran, a currently marketed product containing sucrose as a sweetener, was compared with Questran Light, a new formulation substituting aspartame for 90 percent of the sucrose. Comparisons were conducted with the two products mixed in water and orange juice. The subjects expressed a significant overall preference for the new formulation mixed in either water (77 percent) or orange juice (80 percent) (p less than 0.01 in both comparisons). Subjects expressed an overwhelming preference for the old product (99 percent) with respect to ease of preparation, although the ratings of the new product were generally neutral rather than negative. The new product is somewhat more difficult to prepare compared with the old cholestyramine preparation, but offers significantly increased patient acceptance based on sensory evaluations.

Adult↗
PubMed1989

Prolonged paralysis associated with long-term pancuronium use.

We cared for a 4-year-old patient who had undergone orthotopic liver transplantation and was placed on a ventilator for respiratory distress associated with Pneumocystis carinii pneumonia. The neuromuscular blocking agent pancuronium bromide 1.0-1.2 mg every hour as needed was used to facilitate artificial ventilation for 40 days. On discontinuation of pancuronium, the patient experienced severe, generalized neuromuscular dysfunction. Because no improvement was seen for 2 weeks, the acetylcholinesterase inhibitors edrophonium and pyridostigmine were instituted. Shortly thereafter the patient's condition began to improve. Gradual improvement occurred over 3-4 months and the patient has since returned to baseline neurologic function. We suggest that long-term pancuronium use was the cause of the patient's prolonged paralysis. The improvement experienced after the initiation of antidotal therapy strongly supports our proposal.

Child, Preschool↗
PubMed1989

Idiopathic thromboembolism associated with triphasic oral contraceptives.

Oral contraceptives are one of the most effective and widely used of the reversible contraceptive methods. Thromboembolic disease associated with the use of oral contraceptives has been widely reported. In recent years, attempts to understand the pathogenesis of oral contraceptive-induced thromboembolic disease have found a correlation between larger estrogen doses and increased risk for a thrombotic event. Because the newer triphasic oral contraceptives provide effective contraception with a method of administration that mimics normal hormonal fluctuations during the menstrual cycle, some prescribers may infer that these products are associated with a decreased incidence of adverse effects over alternative oral contraceptives. We present two cases of idiopathic thromboembolism associated with the use of a triphasic oral contraceptive with a discussion of the proposed pathogenic mechanisms for these events.

Adult↗
PubMed1989

A drug information service quality assurance audit.

In this quality assurance audit, 197 drug information requests received over a 10-day period were evaluated for completeness, legibility, and appropriate documentation according to standards set by the ASHP's Special Interest Group on Drug and Poison Information Practice. Deficiencies in documentation of the caller's telephone number (lacking in 21% of forms), time a response was needed (58%), background information (18%), references searched (16%), and staff review (31%) were noted. Corrective action included emphasis on quality control via improved documentation and daily review of completed consultations by senior staff. Three months later, a reaudit of 240 drug information requests found marked improvement in documentation (information regarding the above-mentioned variables was lacking in 1.7%, 2.5%, 2%, 1.3%, and 3.3%, respectively, of request forms). However, increased documentation resulted in increased response times--30% of questions were not answered the same day as asked, and 12% were not answered in the time frame requested.

California↗
PubMed1986

Adverse drug reaction program using pharmacist and nurse monitors.

The feasibility of instituting an adverse drug reaction (ADR) monitoring program was examined. Nurses and pharmacists were requested to fill out an ADR report form whenever a change in a patient's condition or a medication order raised suspicion of a possible ADR. The reports were investigated by the clinical pharmacy resident and evaluated for probable causal relationship, severity, and mechanism. The process used for reporting ADRs is described, and the parameters used to define an ADR are defined. The success of this program in increasing the number of ADR reports is evaluated, and the amount of time required by the various monitors is estimated. This voluntary ADR reporting system did increase ADR documentation in the study institution and may be adopted by P & T Committees in other hospitals.

Documentation↗