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Glossary of Prescription Drug Terms
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Click on the first letter of the word from the list above to
go to the appropriate section of the glossary. Contact us if you would like a
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Legal Glossaries Main Page
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Cardura: A U.S. advisory panel recommended
that regulators require changes to the label for
Pfizer Inc.'s blood pressure drug Cardura. U.S.
researchers determined last year that Cardura was
less effective than an older medicine for treating
certain types of heart disease. "The committee
concluded that something should be communicated to
physicians so they know the results of this trial,"
said Dr. Jeffrey Borer, the panel's acting chairman.
Pfizer Inc.’s Cardura drug is marketed as a class of
blood-pressure medicines known as alpha-blockers.
Researchers said the results of the study suggest
the drugs might not be the best choice as first-line
therapy for high blood pressure and patients now
using them as first-line treatment should talk to
their doctors about whether to change therapy. Last
year, a National Institutes of Health study found
that Cardura users had experienced congestive heart
failure more frequently than those who used a
cheaper diuretic. The FDA advisory panel heard a
petition from a Cardura user who also has filed suit
against Pfizer. The user sought to compel the FDA
and Pfizer to change the drug's labeling and
officially notify users and doctors of the findings
from the NIH study. The lawsuit claims that Pfizer
officials intentionally maneuvered around negative
reports on Cardura, because sales of the drug were
approximately $800 million in 2000. Internal Pfizer
documents and e-mails have surfaced demonstrating
that company officials were less than truthful about
Cardura while avoiding drawing attention to the NIH
study. For example, a company e-mail said that
Pfizer decided at one point not to issue a statement
on the NIH study, which Pfizer paid $30 million to
help fund, and a related announcement from the
American College of Cardiology because "a
Pfizer-issued statement in defense of Cardura would
likely draw more media attention to the situation.
To date, there has been limited media coverage."
Casualty: A loss of property due to fire,
storm shipwreck or other casualty, which is
allowable as a deduction in computing taxable
income.
Cause of Action: The plaintiff’s legal claim
against the defendant. There is often more than one
cause of action in a lawsuit.
Celebrex: Celebrex is a non-steroidal,
anti-inflammatory COX-2 inhibitor drug intended to
treat joint inflammation and arthritis pain, but
like Vioxx it has been deemed dangerous. Celebrex
has been linked to at least 10 deaths, 11 cases of
gastrointestinal bleeding that required
hospitalization, and an increased risk of stomach
ulcers. There is also some evidence that taking
Celebrex can increase or double users' risk of blood
clots, heart attack, and stroke. Despite this
evidence, the makers of Celebrex asked the FDA to
remove label warnings about stomach ulcers, claiming
that medical reviewers did not find any evidence to
suggest that Celebrex was associated with a lower
rate of stomach ulcers than traditional NSAIDs. The
FDA denied the request, as it found that taking
low-dose aspirin (to prevent heart attack) in
combination with Celebrex increased the risk of
developing ulcers.
Cipro: Cipro (Generic name: Ciprofloxacin
hydrochloride) has been linked to side effects
including ruptured tendons and neurological damage
resulting from seizures. Cipro, a member of the
quinolone group of antibiotics is used to treat
bacterial infections of the abdomen, skin, bones,
urinary tract, and lower respiratory system. A
number of side effects have been linked to the use
of Cipro. Side effects may include rashes, fever,
jaundice, shortness of breath, tingling, itching and
hives. Cipro has been linked to tendon ruptures. The
incidences of tendon rupture is more common in the
elderly and individuals on steroid therapy, however,
younger users are at risk too. In 2001, the Epilepsy
Foundation warned that fluoroquinolone antibiotics
such as Cipro can induce seizures in people with
epilepsy.
Civil Law: That part of the law which governs
relationships between people where there is no
criminal activity involved
Civil Liability: In a civil lawsuit, if a
party is found to be at fault, that party is liable.
This is equivalent to a guilty verdict in the
criminal system, except that civil liability usually
means that the party at fault pays money damages to
the other party, whereas the guilty party in a
criminal suit may have to go to prison.
Clinical Trial: A controlled study involving
human subjects, designed to evaluate prospectively
the safety and effectiveness of new drugs or devices
or of behavioral interventions.
Clozaril/ Clozapine: Clozapine is an
anti-psychotic drug used to treat only patients who
have failed to respond to alternative treatment. New
research links Zyprexia (Olanzapine) and Clozaril (Clozapine)
with causing serious side effects including:
Diabetes, Myocarditis, Tachycardia, Tardive
Dyskinesia. Clozaril is manufactured by Novartis.
Clozapine is the generic version of the Novartis
drug Clozaril. Clozaril has been linked to diabetes.
A recent study found 384 diabetes cases, 25 fatal,
have been report to the FDA by Clozaril users. In
February 2001, the FDA and Novartis strengthened the
boxed warning and warning sections as follows: “The
previously existing boxed warning has been relocated
to the beginning of the patient instructions and
revised to advise health care providers of the
association of myocarditis with Clozapine therapy.”
A subsection has been added to the warnings section
entitled "Myocarditis" to provide data and Clozapine
treatment guidelines related to this issue.
Co-Defendant: A defendant joined together
with one or more other defendants in the same case.
Cognitively Impaired: Having either a
psychiatric disorder (psychosis, neurosis,
personality or behavior disorders, or dementia) or a
developmental disorder (mental retardation) that
affects cognitive or emotional functions to the
extent that capacity for judgment and reasoning is
significantly diminished. Others, including persons
under the influence of or dependent on drugs or
alcohol, those suffering from degenerative diseases
affecting the brain, terminally ill patients, and
persons with severely disabling physical handicaps,
may also be compromised in their ability to make
decisions in their best interests.
Comfrey: On Friday July 6, 2001, The US Food
and Drug Administration asked makers of dietary
supplements containing the herb comfrey to withdraw
their products due to the danger of liver damage and
its possible role as a cancer-causing agent. Comfrey
is an herbal medicine that has been marketed to
bruises, wounds, muscle aches and sprains, broken
bones, and ulcers. Comfrey products are made from
the leaves or other parts of the plant grown above
the ground. They can also be made from the roots,
but root preparations are more likely to cause
poisoning. Comfrey contains allantoin, rosmarinic
acid, and pyrrolizidine-type alkaloids. Some believe
that comfrey is a beneficial herb, but scientific
studies show that this herb can be very toxic. If
you drink comfrey preparations or take it internally
in other forms you run the risk of being poisoned.
The FDA stated that "In addition to being toxic to
the liver, there is also evidence that implicates
these substances as carcinogens." Some people have
even died from eating or drinking comfrey remedies.
In a letter to industry groups representing herbal
product makers, the FDA said it was aware of dietary
supplements derived from three types of comfrey that
contain toxic alkaloids. ``The agency strongly
recommends that firms marketing a product containing
comfrey, or another source of pyrrolizidine
alkaloids, remove the product from the market and
alert its customers to immediately stop using the
product,'' FDA said. The following companies have
products that my contain comfrey: Nature's Way, Dr.
Christophers, Herb Farm, Naturade, Bioforce of
America, Solaray and GNC.
Common Law: Body of law that has grown based
on the decisions of courts long ago. It originated
in England and has since passed to the United
States. It is always changing to reflect the current
needs society.
Comparative Negligence: A defense to
negligence used when it is believed that the
plaintiff’s negligence contributed to his or her
injuries. Based on the amount of negligence by each
party, the amount of damages is adjusted
accordingly.
Compensation: Monetary award transferred from
defendant to plaintiff to make up for some wrong,
damage or injury caused by the defendant's actions
or inaction.
Compensatory Damages: Damages awarded to
plaintiffs in order to restore them to the position
they were in prior to being wronged.
Competence: A legal term used to denote
capacity to act on one's own behalf; the ability to
understand information presented, to appreciate the
consequences of acting on that information and to
make a choice.
Complaint: A pretrial document filed in a
court by one party against another that states a
grievance, called a “cause of action.”
Contingency Fee Agreement: An agreement
between an attorney and their client, which allows
the attorney to be paid only if the client prevails
in a lawsuit and collects monetary damages. The
lawyer then receives a percentage of the damages,
generally 1/3 of the award.
Contributory Negligence: A defense to
negligence, which points out that the plaintiff’s
negligence contributed to his or her injuries.
Contributory negligence is an absolute bar to the
plaintiff’s recovery against the defendant.
Counterclaim: A demand by the defendant
against the plaintiff asserting an independent cause
of action in the same lawsuit.
Cox-2 Inhibitor: A drug designed to treat
chronic pain without irritating the stomach and
stomach lining.
Crestor: Crestor is an HMG-CoA reductase
inhibitor drug designed to lower cholesterol levels
by halting production of a certain enzyme in the
liver. The drug has been linked to a slew of serious
health problems, ranging from muscle weakness and
asthenia to kidney damage and total renal failure.
This possibly defective drug is particularly
dangerous to pregnant or nursing mothers, although
it is not currently on the list of drug recalls.
Cross Examination: Questioning the witness
who has been presented by the opposition at trail or
a deposition.
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