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Acute liver toxicity and liver cancer are common features of people exposed to aflatoxin-contaminated food, particularly peoples in developing areas where cereal grains are the staple food in the diet.
Among the remaining 11 participants -- whose caffeine tests had suggested a low risk of drug-related toxicity -- seven showed no significant toxicity from the amonafide dose.
The pharmacokinetic (PK) results of the Phase I clinical trial show that 5-FU, in combination with DAVANAT([R]), remained significantly longer in the bloodstream (up to 10 times), without increasing 5-FU's toxicity in these fragile patients.
The authors' recommendation that toxicity of chemical mixtures be directly assessed on a case-by-case basis (Tinwell and Ashby 2004) would provide a Band-Aid but not a cure to the dilemma of characterizing the hazards of chemical mixtures.
He doesn't advocate that fish oil now be taken with cyclosporine, but does expect a two-year clinical trial currently underway to reveal whether administration of fish oil will lead to lower effective doses of cyclosporine and less kidney toxicity.
These efforts include, among others, the EPA's new cancer guidelines, expected to be finalized in the fall of 2004, which emphasize a full examination of data before invoking defaults; the development of new models to support risk assessment; and an upgrading of the agency's Integrated Risk Information System, which is the principle source of toxicity values used to describe chemical hazards.
John Farber, a professor of pathology at Jefferson Medical College in Philadelphia, has been using in vitro liver cell cultures to test the toxicity of the common analgesic, acetaminophen.
Additionally, as noted by Mauderly (2001), diesel exhaust will age in the atmosphere, and this may affect its toxicity.
Fewer than 50 were treated before the trials were suspended, after liver enzymes in some patients became elevated from 6- to 20-fold--a "substantial signal' of liver toxicity, Leber says.
Also, the absence of known active metabolite in the systemic circulation in humans explains both its higher efficacy in portal circulation and lower systemic toxicity.
According to Pennie and coauthors, the committee's experimental programs have in fact shown that toxicogenomics is an inherently valuable tool for assessing toxicity.