Just as with other commercial products, drugs
marketed to the public may be defectively designed, manufactured or marketed
to the public in a manner that exposes consumers to unreasonable risks.
If you have reason to believe that you have been injured by the use of
any drug, you should consult with your doctor immediately and consider
contacting an attorney. Some of the more noteworthy drugs that have been
the subject of serious safety concerns are the following:
Accutane®
(isotretinoin) – Accutane® is a drug indicated
for the treatment of a specific type of severe acne (severe recalcitrant
nodular acne) that is not responsive to other therapies. On November
23, 2004, the FDA announced that The Food and Drug Administration (FDA)
the strengthening of the risk minimization action plan for Accutane®
and its generic equivalents with the goal of reducing the risk of birth
defects associated with fetal exposure to the drug. On November 18,
2004, FDA researcher Dr. David Graham testified before Congress that
Accutane® should be scrutinized to determine whether the drug should
continue to be marketed in the United States.
Arava®
(leflunomide) – Arava® is used to treat rheumatoid
arthritis. In October of 2003, the manufacturer issued a warning to
health care professionals that there have been reports of liver injuries,
some resulting in death, during treatment with Arava®. There have
also been reports of severe infections, including sepsis, contracted
by patients using Arava®.
Baycol®
(certivastatin) – Baycol® is a drug that was used to
lower cholesterol. In 2001, Bayer Pharmaceutical Division voluntarily
withdrew Baycol® from the U.S. market because of reports of sometimes
fatal rhabdomyolysis, a severe muscle adverse reaction. Symptoms of
rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever,
dark urine, nausea, and vomiting. The pain may involve specific groups
of muscles or may be generalized throughout the body.
Bextra®
(valdecoxib) – Bextra® is a pain reliever
that is typically used to relieve symptoms of osteoarthritis and rheumatoid
arthritis and painful menstrual cycles. Bextra® was approved by
the FDA for the U.S. market on November 16, 2001. Recent studies have
suggested that patients taking Bextra® are at higher risk for heart
attack and stroke. There is also a known risk for a condition called
Stevens-Johnson syndrome, which causes blistering of the skin, eyes
and mouth. On November 18, 2004, FDA researcher Dr. David Graham testified
before Congress that Bextra® should be scrutinized to determine
whether the drug should continue to be marketed in the United States.
Crestor®
(rosuvastatin) – Crestor® is a cholesterol
lowering drug that was approved by the FDA for the U.S. market on August
13, 2003 in the face of strong opposition from the consumer action group
Public Citizen, which cited the alleged risk of kidney toxicity. On
November 18, 2004, FDA researcher Dr. David Graham testified before
Congress that Crestor® should be scrutinized to determine whether
the drug should continue to be marketed in the United States.
Ephedra®
(ephedrine alkaloids) – Ephedra®, also
called Ma huang, is a plant that is a source of ephedrine alkaloids,
including ephedrine and pseudoephedrine. Ephedrine alkaloids have in
recent years been included in a variety of dietary supplements to enhance
weight loss and boost sports performance and energy. Ephedrine alkaloids
are considered to cause stress to the circulatory system and have been
linked to heart attack and stroke. On February 11, 2004, the Food and
Drug Administration (FDA) issued a final rule prohibiting the sale of
dietary supplements containing ephedrine alkaloids because such supplements
present an unreasonable risk of illness or injury.
Fen-Phen
(fenfluramine and phentermine) – Fenfluramine
and phentermine are drugs that that were used for short-term obesity
therapy, and began being widely prescribed "off-label" in
combination (“Fen-Phen”) for long-term management of obesity.
Use of the drugs in combination, and use of fenfluramine individually,
was determined to have a likely link to cardiac valvular disease. In
1997, the FDA requested that that fenfluramine (marketed under the brand
name Pondimin®) be withdrawn from the U.S. market.
Lamictal®
(lamotrigine) – Lamictal® is an antiepileptic drug. In
March 1997, the manufacturer issued new warnings as a result of reports
of severe, potentially life-threatening rashes, including Stevens-Johnson
syndrome, as well as toxic epidermal necrolysis, in some patients who
were using the drug. The revised labeling now includes a boxed warning
that emphasizes that Lamictal® is not indicated for use in patients
below the age of 16 years.
Lamisil®
(terbinafine hydrochloride) – Lamisil®
is used to treat nail infections (onychomycosis). Lamisil® has been
associated with serious hepatic toxicity, including liver failure and
death, including some cases involving patients who had neither pre-existing
liver disease nor a serious underlying medical condition. As of April
2001, the FDA was aware of 16 cases of liver failure in association
with Lamisil® Tablet use (including 11 deaths and two liver transplantations).
Lotronex®
(alosetron hydrochloride) – Lotronex® is a drug used
to treat irritable bowel syndrome in women. In November of 2000, the
drug was withdrawn from the U.S. market as a result of reported cases
of intestinal damage resulting from reduced blood flow to the intestine
(ischemic colitis) and severely obstructed or ruptured bowels (complications
of severe constipation) in some patients using Lotronex®.
Meridia®
(sibutramine hydrochloride monohydrate) – Meridia®
is a weight loss drug. Prior to its approval for the public market in
1997, an FDA advisory panel had recommended that it not be marketed
to the general public because of their concerns about the risks of elevated
blood pressure and heart rate in patients taking the drug. Since 1997,
the FDA has received numerous reports of adverse reactions to Meridia®
and the consumer action group Public Citizen has submitted a petition
to the FDA seeking the removal of the drug from the market. On November
18, 2004, FDA researcher Dr. David Graham testified before Congress
that Meridia® should be scrutinized to determine whether the drug
should continue to be marketed in the United States.
Oxycontin®
(oxycodone hydrochloride) – Oxycontin® is used in
the treatment of chronic pain in time-release capsule form. It has an
addiction potential similar to that of morphine. When the tablet is
crushed and its contents are injected intravenously or snorted into
the nostrils, the controlled release mechanism is defeated and a potentially
lethal dose of oxycodone is released immediately. Because of widespread
reports of Oxycontin® abuse, in some cases resulting in death, the
FDA in 2001 strengthened the warnings and precautions required on the
product.
PPA
(phenylpropanolamine) – Phenylpropanolamin, or PPA, is
used in prescription and over-the-counter drug products as a nasal decongestant
to relieve stuffy nose or sinus congestion and in weight control drug
products to control appetite. On May 11, 2000, the FDA received results
of a study conducted by scientists at Yale University School of Medicine
that showed an increased risk of hemorrhagic stroke (bleeding of the
brain) in people who were taking products containing PPA. The FDA has
since requested that all products containing the drug be withdrawn from
the U.S. market.
Propulsid®
(cisapride) – Propulsid® was used as a treatment
for severe nighttime heartburn. In 2000, it was voluntarily withdrawn
from the U.S. market after it was linked to heart rhythm abnormalities.
Redux®
(dexfenfluramine) – Redux® is a drug that was used for
short-term obesity therapy. Use of the drug was determined to have a
likely link to cardiac valvular disease. In 1997, the FDA requested
that that dexfenfluramine be withdrawn from the U.S. market.
Rezulin®
(troglitazone) – Rezulin® is a drug that was used
for the treatment of Type 2 diabetes. The manufacturer voluntarily withdrew
Rezulin® from the U.S. market after studies showed that drug was
more toxic to the liver than other drugs that offered a similar benefit.
Serevent®
(salmetrol xinafoate) -- Serevent® is a long-term asthma control
medicine. Serevent® is also available combined with Flovent®
(an inhaled steroid) under the brand name Advair®. In agreement
with the FDA, the manufacturer of Serevent® conducted a study commencing
in 1996. In 2002, the interim results of that study indicated that there
was a higher number of asthma related deaths among asthma sufferers
taking Serevent® than among the non-Serevent® patients, although
the manufacturer contended that the differences were not significantly
relevant. On November 18, 2004, FDA researcher Dr. David Graham testified
before Congress that Serevent® should be scrutinized to determine
whether the drug should continue to be marketed in the United States.
Sporanox®
(itraconazole) – Sporanox® is used to treat nail
(onychomycosis), skin and other systemic fungal infections. Sporanox®
has been associated with serious liver problems resulting in liver failure
and death in some patients. In addition, studies have revealed a potential
for the drug to weaken the force of the heart muscle's contractions.
The FDA has added additional information to the current "black
box" warning in the Sporanox® labeling that states that Sporanox®
should not be administered for the treatment of fungal nail infections
in patients with evidence of cardiac dysfunction, such as CHF, or a
history of CHF. The advisory also alerts healthcare professionals to
rare cases of serious liver problems including liver failure and death
associated with the use of Sporanox® products.
Vioxx®
– Vioxx® was recently been removed from the U.S. market by
its manufacturer after an internal study reflected an increased risk
of heart attack and stroke for users of the drug. The drug had been
marketed in the U.S. since 1999 as a treatment for arthritis and other
types of pain. It is one of a new class of drugs called Cox-2 inhibitors.
Previous clinical studies had found a higher cumulative rate of serious
cardiovascular thromboembolic adverse events (such as heart attacks,
angina pectoris, and peripheral vascular events) in patients using Vioxx®
compared to patients using naproxin.
