Pharmaceutical Legal Glossary
Glossary of Pharmaceutical Terms
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z #
Click on the first letter of the word from the list above to go to the appropriate section of the glossary.
- R -
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.
