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Biomedical subjects

Thomas J Moore

Publications and source records attributed to Thomas J Moore.

7 recordsLinked to original sources
PubMed2004

Reported medication errors associated with methotrexate.

PURPOSE: Medication errors reported to FDA as adverse events in which methotrexate was identified as a possible contributor were studied. METHODS: All adverse-event reports submitted to FDA between November 1997 and December 2001 indicating potential medication errors involving methotrexate were analyzed to determine the indication for use, the type of error, and the point in the medication-use process where the error occurred. RESULTS: A total of 106 cases of reported medication errors associated with methotrexate were identified, including errors resuiting in 25 deaths (24%) and 48 other serious outcomes (45%). The most common types of errors involved confusion about the once-weekly dosage schedule (30%) and other dosage errors (22%). The most frequently involved indication for use was rheumatoid arthritis (42%). Of the errors, 39 (37%) were attributable to the prescriber, 21 (20%) to the patient, 20 (19%) to dispensing, and 18 (17%) to administration by a health care professional. CONCLUSION: A review of medication errors involving methotrexate revealed that errors occurred during all phases of use, often resulted from confusion about dosage, and often caused death or other serious adverse effects.

Adult↗
PubMed2004

Reported adverse event cases of methemoglobinemia associated with benzocaine products.

BACKGROUND: Methemoglobinemia (MHb) is characterized by abnormal levels of oxidized hemoglobin that cannot bind and transport oxygen. When induced by benzocaine anesthetic spray and other chemicals, it can result in cyanosis and life-threatening complications. METHODS: From 818 439 adverse event reports received by the US Food and Drug Administration from November 1997 through March 2002, we extracted every report for use of a benzocaine product. We classified each case by product type (eg, spray, gel, or solution), by whether MHb was involved, and by the dose given. RESULTS: Among 198 reported adverse events of all types associated with benzocaine, 132 cases (66.7%) involved definite or probable MHb. The MHb cases included 107 serious adverse events (81.1%) and 2 deaths (1.5%). In 123 cases (93.2%), the product was a spray; in 2 cases (1.5%), a benzocaine-containing lozenge; and 1 case, a gel. In the 69 cases that specified a dose, 37 (53.6%) indicated that a single spray was applied (approximately the recommended amount). CONCLUSIONS: Health professionals involved in endoscopy, intubation, bronchoscopy, or similar invasive procedures using benzocaine-containing sprays should know that (1) administration may cause MHb with potentially serious consequences, (2) identifying the reaction to benzocaine usually requires cooximetry (although it can be implied by symptoms), and (3) treatment involves immediate intravenous administration of 1 to 2 mg/kg of methylene blue.

Adult↗
PubMed2004

Effect of the dietary approaches to stop hypertension diet and reduced sodium intake on blood pressure control.

The authors hypothesized that the Dietary Approaches to Stop Hypertension (DASH) diet and reduced sodium intake would control stage 1 hypertension and reduce high-normal blood pressure (BP) to optimal levels. Adults with systolic BP 120-159 mm Hg and diastolic BP 80-95 mm Hg were randomly assigned to receive the DASH diet or a typical American (control) diet, consuming three different sodium intakes (higher=142 mmol/d, intermediate=107 mmol/d, and lower=65 mmol/d) for 30 days each. BP control was defined as systolic BP <140 mm Hg and diastolic BP <90 mm Hg. Among subjects with hypertension at baseline, at higher sodium intake the DASH diet increased BP control two-fold over control (63% vs. 32%; 95% confidence interval, 1.4-2.9). Reducing sodium intake in the control diet group increased BP control 2.3-fold (74% vs. 32%; 95% confidence interval, 1.7-3.2). The maximum BP control rate (84%) was achieved with the DASH/lower sodium diet. BP became normal or optimal in 71% of persons consuming the control/lower sodium diet and 77% of persons consuming the DASH/lower sodium diet. Both the DASH diet and reduced sodium intake improved BP control.

Adult↗
PubMed2003

Individual blood pressure responses to changes in salt intake: results from the DASH-Sodium trial.

Although group characteristics are known to influence average blood pressure response to changes in salt intake, predictability of individual responses is less clear. We examined variability and consistency of individual systolic blood pressure responses to changes in salt intake in 188 participants who ate the same diet at higher, medium, and lower (140, 104, 62 mmol/d) sodium levels for 30 days each, in random order, after 2 weeks of run-in at the higher sodium level. Regarding variability in systolic blood pressure changes over time, changes from run-in to higher sodium (no sodium level change) ranged from -24 to +25 mm Hg; 8.0% of participants decreased > or =10 mm Hg. Regarding variability in systolic blood pressure response to change in sodium intake, with higher versus lower sodium levels (78-mmol sodium difference), the range of systolic blood pressure change was -32 to +17 mm Hg; 33.5% decreased > or =10 mm Hg. Regarding consistency of response, systolic blood pressure change with run-in versus lower sodium was modestly correlated with systolic blood pressure change with higher versus medium sodium; systolic blood pressure change with higher versus lower sodium was similarly correlated with run-in versus medium sodium (combined Spearman r=0.27, P=0.002). These results show low-order consistency of response and confirm that identifying individuals as sodium responders is difficult. They support current recommendations for lower salt intake directed at the general public rather than "susceptible" individuals as one of several strategies to prevent and control adverse blood pressures widely prevalent in the adult population.

Adult↗
PubMed2003

The DASH diet enhances the blood pressure response to losartan in hypertensive patients.

BACKGROUND: The Dietary Approaches to Stop Hypertension (DASH) diet, which emphasizes fruits, vegetables, and low fat dairy products, significantly lowers blood pressure (BP). We conducted a clinical trial to assess the BP response to the DASH diet with an antihypertensive medication, losartan, in participants with essential hypertension. METHODS: A total of 55 hypertensive participants were randomly assigned to 8 weeks of controlled feeding with either a control diet or the DASH diet. Within each diet arm, participants received losartan 50 mg daily or placebo for 4 weeks each, in double blind, randomized, cross-over fashion. Twenty-four-hour ambulatory BP (ABP) was measured at the end of a 2-week run-in period (baseline) and after each 4-week intervention period. RESULTS: There was no significant change in ABP during the placebo period on the control diet (n = 28) (-2.3 +/- 1.5/-1.6 +/- 1.0 mm Hg), but there was a significant reduction in systolic ABP (-5.3 +/- 1.5 mm Hg, P <.05) and no change in DBP (-2.5 +/- 1.0 mm Hg) on the DASH diet (n = 27). Losartan significantly reduced ABP on the control diet (-6.7 +/- 1.5/-3.7 +/- 1.0 mm Hg, P <.05) and to a greater extent on the DASH diet (-11.7 +/- 1.5/-6.9 +/- 1.0 mm Hg, P <.05 versus basal and control diet) particularly in African Americans. On the DASH diet, DeltaSBP on losartan was inversely related to basal plasma renin activity (n = -0.53, P =.004). CONCLUSIONS: The DASH diet enhances the ABP response to losartan in essential hypertension. This effect is particularly marked in African Americans.

Adult↗
PubMed2002

Reported adverse drug events in infants and children under 2 years of age.

OBJECTIVE: To characterize risks to infants and young children from drugs and biological products that were identified in spontaneous adverse event reports submitted to the US Food and Drug Administration. METHODS: Of >500 000 MedWatch adverse event reports received by the Food and Drug Administration from November 1997 through December 2000, we identified 7111 reports about infants and children younger than age 2. The reports were analyzed for health outcome (eg, death, hospitalization, congenital anomaly), principal suspect drug, and whether the route of drug exposure was direct administration or through the mother in the perinatal period. RESULTS: Drug therapy was associated with an average of 243 reported deaths annually over the 38-month study period, with 100 (41%) occurring during the first month of life and 204 (84%) during the first year. In 1432 (24%) reported adverse event cases of all levels of severity, exposure to the drug was from the mother during pregnancy, delivery, or lactation. Although 1902 different drugs, biological products, and other chemicals were identified in the reports, only 17 drugs or biological products were a suspect in 54% of all serious and fatal adverse events in drugs administered directly. CONCLUSION: Adverse reactions to drug therapy are a significant cause of death and injury in infants and children under 2 years of age. Drugs administered to the mother in the perinatal period constituted a major route of exposure to adverse drug advents. These results underscore the need for additional drug testing in the youngest pediatric patients and for carefully weighing the risks versus benefits of medication.

Adverse Drug Reaction Reporting Systems↗