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Side Effects & Adverse Reactions
An adverse drug reaction (abbreviated ADR)
is a term to describe the unwanted, negative
consequences sometimes associated with the use of
medications. ADR is a particular type of adverse effect.
The term is preferred over the colloquial and imprecise
"side effect", as the term "side effect" implies the
potential for beneficial consequences and that the
effects are not explained by the pharmacological actions
of the drug.
While ADR is probably the most precise term to describe
the concept, it is not widely used in the community
since it may be perceived as jargon and because of the
negative-associations with the term "drug". Alternative
terms with equivalent meaning to ADR include: side
effect, adverse event, adverse effect, etc. You
can cross-reference your medication with potential
reported side effects at the National Institute for
Health
Website.
There are many types of ADRs:
Type A, pharmacologically predictable
Type B, bizarre and unpredictable
Type C, arising from chronic use
Type D, delayed reaction
Type E, end of dose reaction
Type F, Failure of therapy
Make sure your doctor explains any and
all associated risks, potential side effects, and
adverse reactions that your prescribed drug may cause.
Keep a watchful eye for these reactions, and report
anything abnormal to your physician as soon as possible.
Adverse effects can occur as a collateral
or side effect of many interventions, but they are
particularly important in pharmacology, due to its
wider, and sometimes uncontrollable, use by way of
self-medication. Thus, responsible drug use becomes an
important issue here.
Adverse effects, like intended effects of drugs, are a
function of dosage or drug levels at the target organs,
so they may be avoided or decreased by means of careful
and precise pharmacodynamics (the change of drug levels
in the organism in function of time after
administration).
Adverse effects may also be caused by drug interaction,
i.e., when physicians fail to check for all medicaments
a patient is taking and prescribe new ones which
interact agonistically or antagonistically (potentiate
or decrease the intended therapeutic effect).
Significant morbidity and mortality is caused around the
world because of this. Drug-drug and food-drug
interactions may occur, and even so-called "natural
drugs" used in alternative medicine may have dangerous
adverse effects. For example, extracts of St. John's
wort (Hypericum perforatum), a phytotherapic used for
treating mild depression are known to cause an increase
in the cytochrome P450 enzymes responsible for the
metabolism and elimination of many drugs, so that
patients taking it are likely to experience a reduction
in blood levels of drugs that they are taking for other
purposes, such as cancer chemotherapeutic drugs,
protease inhibitors for HIV and oral contraceptives.
The scientific field of activity associated with drug
safety is increasingly government-regulated and is of
major concern for the public as well as to drug
manufacturers. The distinction between adverse and
non-adverse effects is a major undertaking when a new
drug is developed and tested before marketing it. This
is done in toxicity studies to determine the non-adverse
effect level (NOAEL). These studies are used to define
the dosage to be used in human testing (phase I) as well
as to calculate the maximum admissible daily intake.
Imperfections in clinical trials, such as insufficient
number of patients or short duration, sometimes lead to
public health disasters such as those of fenfluramine
(the so-called fen-phen episode), thalidomide and, more
recently, of cerivastatin (Baycol®, Lipobay®) and
rofecoxib (Vioxx®), where drastic adverse effects were
observed, like teratogenesis, pulmonary hypertension,
stroke, heart disease, neuropathy, etc., and a
significant number of deaths, causing the forced or
voluntary withdrawal of the drug from the market.
Most drugs have a large list of non-severe or mild
adverse effects which do not rule out the interruption
of usage. These effects have widely variable incidence,
according to individual sensitivity. They comprise
nausea, dizziness, diarrhea, malaise, vomit, headache,
dermatitis, dry mouth, etc.
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