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Over the last decade, the Food
& Drug Administration (FDA) has removed from the market
numerous drugs. Generally the manufacturer had made assurances
to get FDA approval that the drugs’ benefits outweighed the
risks. However, after being released to the market, adverse
reactions were reported and, on further investigation, it was
shown that in some situations not all evidence of the drugs’
risks were disclosed. Some of the drugs listed below have been
taken off the market while others are still being used.
Duract
Manufactured by American Home
Products, this was a non-steroidal anti-inflammatory drug that
was widely prescribed for pain in 1997 and 1998. In May 1998,
it was removed from the market because of a large number of
adverse drug reaction reports. In some cases use of this drug
led to elevated liver enzymes and eventually to liver failure
necessitating liver transplant. In some situations it even led
to death. The initial symptoms of liver damage are abdominal
pain, swelling in the stomach and extremities, brown urine,
yellow eyes and jaundice.
Omniscan (MRI Dye)
Omniscan (gadodiamide) is a
gadolinium containing contrast agent (MRI dye) commonly used
by physicians in magnetic resonance imaging (MRI) and/or
magnetic resonance angiography (MRA). In June 2006,
physicians were warned about the use of the
Omniscan contrast medium
(dye) in an MRI or MRA where patients had a pre-existing
renal (kidney) problem over concerns that the patient might
develop a very serious medical condition involving the skin
called Nephrogenic Systemic Fibrosis (NSF). That condition
is characterized by a hardening of the skin and other
serious health problems.
Fen - Phen
This diet drug combination
involved the use of Fenfluramine (known as Pondimin) and
Phentermine (Fastin, Adipex, etc.). In September of 1997, the
FDA ordered the removal of both Pondimin and Redux from the
market. The drugs were manufactured by American Home Products.
These drugs caused Primary Pulmonary Hypertension (PPH) which
is an elevation of blood pressure in the passageway between
the heart and the lungs and damage to the user's mitral and
aortic heart valves.
Trovan
Trovan is a vigorous antibiotic
that is used to combat a wide range of infections.
Manufactured by Pfizer, the drug is highly liver toxic. In
some cases use of this drug led to elevated liver enzymes and
eventually to liver failure necessitating liver transplant. In
some situations it even led to death. The following, initial
symptoms are associated with liver damage: abdominal pain,
swelling in the stomach and extremities, brown urine, yellow
eyes, extreme fatigue and jaundice. In June 1999, Pfizer
restricted the use of this drug to situations in a hospital
environment and under life-threatening conditions.
Ketek
Ketek (Telithromycin) is an
antibiotic used to treat certain respiratory (lung and
sinus) infections, including bronchitis and pneumonia. On
January 20, 2006, researchers reported three cases of severe
liver problems associated with Ketek, including one death,
in patients at a North Carolina hospital.
Posicor
Manufactured by Roche
Laboratories, Posicor was a calcium channel blocker. It was
used to treat blood pressure problems in patients. In June
1998, it was pulled from the market when it was determined
it was dangerous when used in combination with one of more
than 25 other drugs, ranging from antibiotics to allergy
drugs. Problems associated with the drug include heart and
liver problems.
Serentil
This drug has been used to
treat patients with schizophrenia. The drug has been found to
cause heart related problems severe enough to cause death. An
irregular heartbeat is the symptom most commonly associated
with its use.
Enbrel
This drug is used primarily to
treat rheumatoid arthritis. It has been on the market in the
United States since November 1998. Recent studies have shown
Enbrel can cause disorders of the central nervous system. Some
patients using this drug have also developed bleeding
problems.
Raplon
Raplon was a muscle relaxant
prescribed by doctors and anesthesiologists to some patients
by injection before hospital or surgical procedures. In March
of 2001, Organon, Inc., the manufacturer, voluntarily withdrew
the product from the market because it may have been linked to
5 deaths and 90 other problems related to bronchospasm which
is an inability to breath normally. Bronchospasm can range
from mild to severe.
The FDA approved Raplon for
sale in August of 1999. Before it was approved, there were
reports of bronchospasm in the clinical trials but they were
considered to be no different than what would be expected in
the general population. New reports seriously challenge the
pre-clinical findings. Indeed, the FDA noted that the post
market survey of the drug indicates "that the risk of
injury may be greater than what was suggested." Trasylol
Coronary bypass patients that were given the drug Aprotinin, sold under the brand name of Trasylol, should be aware that the product has been linked to kidney failure, heart attacks and strokes -- and implicated in thousands of deaths.
Pharmaceutical Litigation FAQs
Who is liable for harm
suffered from prescription drugs?
I have been taking a drug that
was not prescribed by a physician; do I still have a possible
legal remedy for injuries suffered from these drugs?
What is a class action
lawsuit?
What drugs are most commonly
found in drug litigation claims?
Is anything being done to warn
consumers about the possible dangers of taking prescription
drugs?
What is an “off-label”
drug?
Why would anyone use a drug
for any reason other than what it was intended?
What are the most common uses
of off label drugs?
What should I do if my doctor
prescribes a drug for off label use?
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