| "Taking an expensive breast cancer drug on a full stomach � as opposed to an empty one as prescribed � could save a patient or their health authority $1700 (�835) a month or more, according to an analysis of data from clinical trials." "The approach, which might also work for other drugs, is based on the fact that certain foods can delay the breakdown of medications in the body. Doctors stress, however, that people should not yet attempt this cost-cutting method until studies demonstrate its safety." "In general, taking pills with food against the label's advice can lead to an overdose. For example, drinking " "For this reason, pharmaceutical companies must provide the US Food and Drug Administration (FDA) with information on how eating a meal can influence the absorption of their products." "Pharmaceutical companies generally tell patients in early drug trials to take the medication on an empty stomach, as this helps reduce the variables between patients." "In this instance, when researchers later conducted the food-interaction experiments involving lapatinib, they found that taking it at mealtime raised blood levels of the drug far above those shown as safe in previous trials. This meant that the drug label would have to advise patients to take the pill on an empty stomach." "The FDA approved lapatinib in March 2007 to treat breast cancers that have not responded to other medications. Specifically, the drug fights breast cancers that contain an excess of a protein called "human epidermal growth factor receptor 2" (HER2), and have spread through the body." "This subtype of breast cancer claims the lives about 8000 to 10,000 US women each year, according to the American Cancer Society. But this help does not come cheap. Lapatinib costs a patient roughly $2900 a month, a large sum, particularly for those who lack health insurance." "Ezra Cohen and Mark Ratain at the University of Chicago, Illinois, US wondered if taking advantage of changes in lapatinib absorption after eating could reduce this cost." "Based on clinical trial data submitted to the FDA, they calculated that taking the medication with a low-fat meal or high-fat meal could increase the amount of lapatinib circulating in the blood by 1.7 and 3.3 times, respectively. Adding grapefruit juice to the mix would reduce costs further still." ""We expect that one 250 milligram lapatinib pill accompanied by food and washed down with a glass of grapefruit juice may yield plasma concentrations ... read the whole article |