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Knowledge about drug and intervention side effects is Power
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The number one reason drugs or supplements could be providing more harm than good is LIVER TOXICITY.
Early detection of function changes,
including toxicity, is a logical complement to today’s increasing interest in health and fitness, and should be a part of every health-conscious person’s preventative health care program.
Excerpt from:
FDA-PhRMA-AASLD Hepatotoxicity Steering Committee Meeting, February, 2005
Abstract:
Drug-induced liver injury (DILI) is a serious and growing problem.
It is serious because it now accounts for more United States cases of acute
liver failure than all other causes combined, and is growing because more and
more people are consuming more and more drugs, prescription and
non-prescription, plus so-called “dietary supplements,” “recreational”
substances, special diets, and alcohol. In dealing with this problem in our
population, a first requirement is that we detect it, soon enough that the
offending agent is stopped before irreversible liver injury occurs.
We need to develop methods to be reasonably certain that the
observed liver injury is indeed probably caused by the drug in question, and
that the injury is likely to become worse to produce disabling,
life-threatening, or fatal DILI. Fortunately, drug development safeguards of
animal studies and controlled clinical trials eliminate most of the truly
toxic agents, but these safeguards do not detect the uncommon but serious
DILI that results from human individual idiosyncrasies in genetic or acquired
factors that increase the susceptibility of a few persons to DILI. This
occurs despite that fact that the great majority tolerate the drug without
adverse liver effects, or that most of those who do not initially do so can
successfully adapt to the drug and tolerate it thenceforth.
Excerpt
Clinical Picture and Issues in the Clinical Phases of Drug Development
Neil Kaplowitz, M.D.
University of Southern California, Los Angeles
Drug-induced liver disease can mimic all forms of acute and chronic
hepatic diseases. However, the predominant clinical presentations resemble
acute icteric hepatitis or cholestatic liver disease. The former is of grave
significance as the mortality approximates 10% due to acute liver failure.
What does this mean in simpler terms?
The FDA doesn’t require drugs or supplements to identify your
risk of liver injury, unless they expect it to be life threatening! Their
review process doesn’t try to detect the possibility of liver toxicity
which may be very detrimental to your wellness (but not life threatening)
or sub-clinical changes that produce chronic sub-optimal liver function.
“In brief, liver functions are divided into three basic
categories: regulation, synthesis and secretion of substances important to
bodily homeostasis. This includes storage of nutrients such as glycogen;
vitamins and minerals; and the purification, transformation and clearance
of waste products, drugs and toxins. Disease, injury and toxic insult
greatly reduce the liver’s ability to carry out these activities. Most of
the clinical manifestations of liver dysfunction stem from cell damage and
impairment of liver capacities.”
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