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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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F -
FDA: Food and Drug Administration; an
agency of the federal government established by
Congress in 1912 and presently part of the
Department of Health and Human Services.
Fen-Phen: Short for fenfluramine phentermine,
a drug combination used for weight loss purposes.
Fen-Phen has been linked to heart valve disease in
numerous cases, prompting the FDA to request that
manufacturers recall the drug. A combination of
fenfluramine (Podimin), phentermine (Ionamin), and
dexfenfluramine, Fen-Phen, a defective drug, was
used by at least 6 million Americans until it was
recalled in 1997 after reports linked it to heart
valve disease, primary pulmonary hypertension (PHH),
heart failure, lung failure, aortic and mitral heart
valve damage (regurgitation), and other serous
conditions.
Fentanyl: On Friday, July 15, 2005, the FDA
warned that the pain relief patch Duragesic could
cause drug overdoses and said it was looking into
reports of 120 deaths and other serious side effects
from overdoses in patients using the skin patches
for pain control. Johnson & Johnson’s Duragesic
patch contains fentanyl, which is a strong, opioid
narcotic painkiller. Deaths and overdoses have
occurred in patients using both the brand name
product Duragesic and the generic product fentanyl.
The FDA believes that the chief cause of the deaths
and overdoses of patients using fentanyl transdermal
(skin) patches is lack of knowledge: The agency has
stated that some patients and health care providers
may not be fully aware of the dangers of the potent
morphine-like drug. The directions for using the
patch must be followed exactly to prevent death or
other serious side effects. The FDA has proposed
precautions regarding the safe use of the patches,
including patient education regarding signs of
overdose, proper patch application, use of other
medications while using the patch, safeguards for
children, and proper storage and disposal. Duragesic
has been on the market since 1990, and the FDA said
the 120 deaths reported to the agency spanned the
entire period from 1990 to present. Mylan
Laboratories Inc. began marketing a generic version
of the drug this year. The Duragesic patch can
provide up to three days' relief from severe chronic
pain, but an overdose of the morphine-like drug can
put a patient into a coma and shut down breathing.
In addition to trouble breathing or shallow
breathing, the other signs of fentanyl overdose
include:
- Tiredness
- Extreme sleepiness
- Inability to think, talk or walk normally
- Feeling faint, dizzy or confused
People experiencing the symptoms should get
medical attention immediately. The FDA also alerted
doctors that they should prescribe the lowest
effective dose of the medication, and that the
patches should not be used to treat short-term pain
or pain after an operation. Patients should not use
patches that are damaged or broken, the FDA said.
They also should not drink alcoholic beverages or
sit in the sun while taking the drug, because
alcohol and a rise in body temperature can
accentuate the narcotic effects. While the FDA is
primarily targeting patient education, it is not
ruling out the possibility that problems or defects
with the patches may have caused some of the 120
deaths. The fentanyl investigation is in its early
stages, FDA officials said, and the agency has
reached no decision on whether the patches should be
recalled or their use limited.
Final Judgment: The written ruling on a
lawsuit by the judge who presided at trial. This
completes the case unless it is appealed to a higher
court. May also be referred to as a final decree or
final decision.
Fosamax: Manufactured by Merck, gained FDA
approval in 1995. It is a medication used for bone
loss, but has been implicated in the serious
necrosis of the jaw and other bones, a condition
known as “osteonecrosis,” also called “bone death.”
Fosamax is a bisphosphonate medication used to
increase bone mass, reduce bone fractures and
prevent and treat osteoporosis in post-menopausal
women. However, cases of osteonecrosis (involving
the jaw) have been reported in patients treated with
bisphosphonates. The majority of the reported cases
are in cancer patients who are having, or have had,
a dental procedure. With osteonecrosis, the bone
tissue in the jaw fails to heal after minor trauma,
such as a tooth extraction, causing the bone to be
exposed. The exposure can eventually lead to
infection and fracture and may require long-term
antibiotic therapy or surgery to remove the dying
bone tissue. Experts say that prevention and early
treatment of individuals using bisphosphonates such
as Fosamax is extremely important in preserving the
jaw bone. Individuals using Fosamax or other
bisphosphonates should attempt to avoid tooth
extractions and other major dental work while on the
drugs. The discovery of the Fosamax-osteonecrosis
connection was first published in the Journal of
Oral and Maxillofacial Surgeons in May 2004. That
information prompted the U.S. Food and Drug
Administration to require that all bisphosphonate
labels should mention osteonecrosis. Other drug
companies updated their labels to include the
warnings in 2004. To date, Merck has not included
the warning on its Fosamax label. Bisphosphonates
remain in bone indefinitely. Symptoms of bone death
in the jaw include:
- Pain
- Swelling
- Infection of the gums
- Loosening of the teeth
- Poor healing of the gums
- Numbness, or a feeling of heaviness in the
jaw
- Exposed bone
Fosamax can also irritate the esophagus, and care
must be taken in order to avoid such irritation.
Recently, researchers discovered that taking Fosamax
in combination with the popular arthritis drug
Naproxin may increase the risk of developing stomach
ulcers.
Fraud: Occurs when intentional false
statements are made to entice a victim to give up
something of value.
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