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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
personal injury law glossary or one of other legal glossaries for your website.
Legal Glossaries Main Page
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Radioactive Drug Research Committee: An
institutional committee responsible for the use of
radioactive drugs in human subjects for research
purposes. Research involving human subjects that
proposes to use radioactive drugs must meet various
FDA requirements, including limitations on the
pharmacological dose and the radiation dose.
Furthermore, the exposure to radiation must be
justified by the quality of the study and the
importance of the information it seeks to obtain.
The committee is also responsible for continuing
review of the drug use to ensure that the research
continues to comply with FDA requirements, including
reporting obligations. The committee must include
experts in nuclear medicine and the use of
radioactive drugs, as well as other medical and
scientific members
Radioactive Drug: Any substance/drug that
exhibits spontaneous disintegration of unstable
nuclei with the emission of nuclear particles or
photons. Included are any non-radioactive reagent
kit or nuclide generator that is intended to be used
in the preparation of a radioactive drug and
"radioactive biological products." Drugs such as
carbon-containing compounds or potassium-containing
salts containing trace quantities of naturally
occurring radionuclides are not considered
radioactive drugs.
Raplon: Pharmaceutical maker Organon Inc.
withdrew its anesthetic Raplon from the market after
reports that five patients died while being given
the drug. Organon, a unit of Akzo Nobel NV, notified
regulators that it was voluntarily pulling Raplon
after reports showed it may be linked to breathing
trouble that can lead to permanent injury or death.
The FDA cleared Raplon for sale in the United States
in August 1999. Critics have charged the agency with
approving drugs too quickly and later having them
come off the market for safety reasons. The Raplon
review took more than a year, the FDA said. Raplon
was given by injection in hospitals or other
surgical facilities. It was used as a muscle
relaxant for when doctors placed breathing tubes or
for surgery. Officials knew before they approved
Raplon that some patients had an adverse reaction
known as bronchospasm, an inability to breathe
normally that can be mild to severe. In clinical
trials before its approval, 3.2 percent of patients
given Raplon had bronchospasm, compared with 2.1
percent for a comparison drug. That was "not enough
to be worrisome," Jenkins said. But the numbers seen
after the drug became widely available "indicate
that the risk of injury may be greater than was
suggested," an FDA statement said. All drugs similar
to Raplon have been linked with the same problem,
"but this drug (Raplon) seems to be causing more
severe bronchospasm." The problem occurred "very
rapidly" after the drug was injected, Jenkins said.
Patients who received Raplon during previous
procedures without serious trouble "probably don't
need to worry" about having a complication now, he
said.
Reasonable Care: The standard of care in
negligence cases; the duty to act reasonably so as
to avoid harming others.
Relenza: A medicine used to treat influenza
(the flu). Some patients have had serious breathing
problems while using Relenza, and it is not
recommended for those with chronic respiratory
disease.
Remand: The decision of an appellate court to
send a case back to the trial court with
instructions on how to correctly decide the case;
often used with the term “reversed.”
Remedies: Relief that the plaintiff receives
from the defendant in a lawsuit. Often this will
include monetary damages or equitable relief (i.e.
injunctions).
Respondent: The party that won at trail.
Reversed: Reversed means that the appellate
court overturned the trial court’s decision.
Rezulin: Rezulin is an anti-hyperglycemic
drug used to treat Type II diabetes. While it is not
an insulin substitute, Rezulin helps the body better
use the insulin it does produce. Since its approval
by the FDA in 1997, Rezulin, now believed to be a
defective drug, has consistently been linked to
heart failure, thickening in the left ventricular
wall of the heart, severe liver damage, liver
failure, an increased demand for liver treatments,
and at least 63 deaths. Rezulin was finally pulled
from the shelves in March 2000.
RhoGAM: A medicine which was injected into
pregnant women to avoid specific pregnancy
complications. RhoGAM used to contain Thimerosal,
which some suspect is related to the development of
autism. |
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