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Journal ArticleDOI

Is it really OK to take this with food? Old interactions with a new twist.

Allison W. Wallace, +1 more
- 01 Apr 2002 - 
- Vol. 42, Iss: 4, pp 437-443
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TLDR
Revisions of current regulatory guidelines are necessary to take into account this potentially major source of “new” drug interactions.
Abstract
In response to consumers' increased interest in preventive health care, the food industry is producing a variety of foods fortified with calcium, iron, and other minerals and vitamins. This well-meaning idea of food fortification is troubling in the context of clinical pharmacology. The recommended Food and Drug Administration (FDA) meal used in food-drug interaction studies is a high-fat, high-calorie meal with little nutritive value. While some drugs may appear to be safe when taken with food, this may not be true when fortified foods are considered. The mechanisms causing drug-fortified food interactions are the same well-known mechanisms that cause other drug-mineral interactions. Certain drugs may exhibit decreased absorption due to chelation and adsorption. Other drugs may have decreased absorption or increased excretion due to changes in gastric and/or urinary pH. The results of such interactions may be clinically insignificant or severe, including treatment failure, frequent dose changes, antibiotic resistance, and increased morbidity and mortality. Revisions of current regulatory guidelines are necessary to take into account this potentially major source of “new” drug interactions.

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Citations
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Journal ArticleDOI

Food for thought: formulating away the food effect - a PEARRL review.

TL;DR: Food‐mediated effects on bioavailability can have significant consequences in drug development, regulatory and clinical settings and the ability to mechanistically understand the causes and predict the occurrence of these effects is a primary focus of research.
Journal ArticleDOI

Prevention of food-drug interactions with special emphasis on older adults

TL;DR: Prevention of adverse events from food-herb-drug interactions requires clinical monitoring in high-risk regimens and populations as new foods and drugs emerge and more self-medication is promoted.
Journal ArticleDOI

Effects of extracts of commonly consumed food supplements and food fractions on the permeability of drugs across Caco-2 cell monolayers.

TL;DR: Ingestion of extracts of herbs and berries studied are not expected to markedly change the permeabilities of highly permeable drugs, and Harmful effects at sites of or during absorption are unlikely, however, if high doses of extracts are administered with low permeable drug in vitro, effects on drug permeabilities could not be excluded.
Journal ArticleDOI

Lack of bioequivalence when levofloxacin and calcium-fortified orange juice are coadministered to healthy volunteers

TL;DR: The results further confirm the need to adjust regulatory studies to include bioequivalence/bioavailability studies that contain fortified foods more than high‐calorie/high‐fat foods to better reflect current American consumption habits.
Journal ArticleDOI

A randomized, open-label, 5-period, balanced crossover study to evaluate the relative bioavailability of eltrombopag powder for oral suspension (PfOS) and tablet formulations and the effect of a high-calcium meal on eltrombopag pharmacokinetics when administered with or 2 hours before or after PfOS.

TL;DR: In this paper, a single-dose, open-label, randomized-sequence, crossover study, healthy subjects received 25 mg eltrombopag orally as a tablet fasted and as PfOS fasted or with, 2 hours before, or 2 hours after a high-calcium meal.
References
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Journal ArticleDOI

Flecainide: A New Prototype Antiarrhythmic Agent

TL;DR: In vitro, animal and human studies have shown that the drug markedly prolongs conduction and has minimal effect on repolarization, and flecainide is the first class IC antiarrhythmic agent marketed in the United States.
Journal ArticleDOI

The noninterference of aluminum hydroxide gel with quinidine sulfate absorption: An approach to control quinidine-induced diarrhea

TL;DR: Patients who have required quinidine for the successful control of their arrhythmias, but who could not tolerate the resulting gastrointestinal symptoms, particularly diarrhea, were encountered, andConcomitant administration of aluminum hydroxide gel with their qu inidine dose resulted in reduction of diarrhea, with apparently continued control of the arrh rhythmias.
Journal Article

Prescription drug therapy in the podiatric outpatient population: interactions and precautions.

TL;DR: A survey of 2,000 outpatients at the clinic of the Dr. William M. Scholl College of Podiatric Medicine conducted analyzing both medications reported by the patients at the time of treatment and drugs by the attending podiatrist serves as the basis for a review of drug interactions in the podiatric outpatient population.
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