By Independent Staff WriterDetermining Whether You Have an Actos CaseHundreds
of thousands of patients who have taken the drug Actos over the past
few years—believing the drug to be safe—have been very disillusioned to
find that the drug can have some potentially very serious side effects.
Actos is a drug which was developed for the treatment of Type 2 diabetes
and works by helping the body restore its normal response to insulin,
effectively lowering blood sugar. When high blood sugar is not
consistently controlled, kidney damage, blindness, nerve problems and
even the loss of limbs become possible medical issues. The control of
Type 2 diabetes is also necessary to avoid a debilitating heart attack
or stroke. Therefore, when a drug such as Actos seems to do a good job
of lowering blood sugar, it becomes a very popular prescription drug. So
popular that in spite of the recent rash of lawsuits against Takeda—the
manufacturers of Actos—profits have only been dampened by approximately
13%. The pharmaceutical giant is still enjoys some $2.2 billion dollars
in annual profits, down from an all-time high of over 4 billion dollars
in annual profits. If you have taken Actos you may be wondering whether
you might have an Actos case and be entitled to damages. The
FDA issued a warning which cautions patients with a history, diagnosis
or heightened risk of bladder cancer to consider an alternative diabetes
treatment to Actos. Although this warning sounds fairly mild, drug
safety watchdogs are urging anyone who is currently taking Actos to
speak to their doctor about an alternative drug with less risk factor
and are strongly urging those who have taken the drug in the past to ask
their doctor to set up a bladder cancer screening. The common side effects of Actos generally include upper respiratory infections,
headache, sinus infection, muscle pain, tooth problems, sore throat and
swelling or water weight gain. Anyone who has had symptoms which can
suggest bladder cancer such as blood in the urine, pain upon urination,
back or stomach pain, or an urgent need to urinate should immediately
seek medical attention. Because Actos has also been tied to an increased
risk of heart failure, any patient who notices swelling of the feet, a
sudden increase in weight and shortness of breath should also seek
immediate medical attention. In conjunction these symptoms can suggest
congestive heart failure and a buildup of fluid in the lungs. In short,
if you took Actos for a period of more than twelve months, or in very
high dosages, you may be eligible to file an Actos lawsuit.
By Independent Staff WriterCould Your Heart Failure Be Linked to Actos?Links
to higher heart disease rates have been associated with the use of
Actos, and, in fact, Actos may cause as many heart problems as
GlaxoSmithKline’s drug, Avandia. The American Heart Association reported
that studies showed patients taking either diabetes drug were at least
four times as likely to experience heart attacks, heart failure or even
death. When a 2007 study on Avandia showed a 43 percent higher chance of
heart attack, Actos quickly became the market leader. A subsequent
study on both drugs showed that 602 Avandia users and 599 Actos users in
the study suffered either a heart attack, heart failure or both, with
217 deaths in each group. The latest study regarding Actos in the
journal Lancet found the risk for heart failure greatest among those
patients with a prior history of heart disease and heart failure,
however overall the relative risk when taking Actos was as much as 72
percent higher than those not taking the drug. Both Glaxo and Takeda
dispute the results of these negative studies, citing a study published
in the Journal of the American Medical Association which suggests Actos
might actually cut the risk of heart attack, stroke and death. Link between Actos and Heart FailureActos
is in a class of drugs known as thiazolidinediones, whose use has long
been attributed to certain liver and cardiovascular health issues. A
listed side effect of Actos includes the threat of congestive heart
failure with the link between Actos and congestive heart failure being
so undeniable that in 2007 the FDA escalated warnings regarding heart
disease when taking the drug. Actos causes the body to retain excess
fluid, leading to swelling and weight gain. This extra body fluid can
worsen some heart problems, leading to heart failure or can actually
cause heart problems. When
Actos causes swelling in the body, this swelling also occurs around the
heart, rendering it unable to effectively pump blood throughout the
body. As fluid builds up around the heart and lungs, it becomes more
difficult for the heart to pump, causing it to become less and less
efficient. This can lead to shortness of breath, trouble breathing when
lying down, a feeling of excessive tiredness or an unusually rapid
increase in weight. After an intense debate over the cardiovascular
risks of Actos, the FDA agreed to surround the heart risk warnings on
Actos with an emphatic black outline commonly known as a black box
warning. This black box warning is the strongest FDA label change which
can be added to any drug on the market. Link Between Actos and Bladder CancerThe
FDA issued its safety announcement regarding the connection between
using Actos for more than one year and the risk of bladder cancer on
June 15, 2011. The bladder lies in the center of the lower part of the
abdomen, and its primary purpose is to store urine prior to excreting it
from the body. When cells in the bladder become cancerous, a tumor can
form. Actos helps diabetics use their own insulin better by hitting at
least two of the three main PPAR receptors known as the Gamma and Alpha
receptors. The Gamma receptor works on glucose while the Alpha receptor
affects cholesterol. Actos appears to have a higher affinity with the
Alpha receptor which is why it does a good job on raising good
cholesterol and lowering triglycerides.
Actos® and Bladder CancerRecent
studies have shown that patients taking the drug Actos for longer than
one year may suffer significantly increased risks of developing bladder
cancer. The FDA warnings are being issued on the heels of France and
Germany banning the use of Actos, and New Zealand also beginning the
process of removing Actos from patient use. Takeda Pharmaceuticals, the
Japanese corporation who began manufacturing Actos in 1999, is at the
midway point in a ten-year study of the drug’s potentially serious side
effects. While the five-year data shows no clear evidence of an overall
increased risk of bladder cancer, patients who have taken the drug in
the highest dosages or for the longest period of time appeared to be at a
much greater risk of developing bladder cancer. Actos
is in a class of drugs known as thiazolidinediones, and is the second
medication of its class to be associated with serious side effects.
Avandia, the sister-drug of Actos, recently had its use severely
restricted due to evidence of increased heart attack risk and even
death. When metformin alone no longer works well for patients suffering
from type 2 diabetes, doctors typically prescribe a drug such as Actos
which increases the body’s insulin sensitivity, controlling blood sugar
levels in the process. Type 2 diabetes, when left untreated, can
potentially lead to serious health effects such as damage to the retina
which can lead to blindness, injury to the kidneys, impairment of the
nerves which could lead to amputations of limbs and an acceleration of
the development of fat plaques on the interior of the arteries which can
potentially lead to blood clots, blockages, cardiovascular disease,
stroke and a lessening of critical circulation.
Actos® and Congestive Heart FailureThe
drug Actos, also known as pioglitazone is marketed by Takeda
Pharmaceuticals and Eli Lilly for the treatment of Type 2 diabetes. The
drug was approved in 1999, and although the manufacturer touts it as a
miracle drug which has reduced the number of diabetes cases by as much
as 70%, the side effects may far outweigh the benefits. A study done in
2003 by the Mayo Clinic definitively linked Actos to swelling in the
feet, lung fluid retention, shortness of breath and congestive heart
failure. The most recent studies have strongly indicated that Actos may
also be responsible for a number of incidences of bladder cancer in
those who have taken the drug in higher dosages or for longer than
twelve months. The American
Diabetes Association presented a research report at a meeting in San
Diego this past June which reported that Actos enhanced the risk of
macular edema by as much as six times, causing thickening and swelling
of the retina and leading to blindness. Another study which was reported
in the American Heart Association Journal in August, 2010, associated
Actos with an increased risk of death due to congestive heart failure.
Although the FDA had mandated a black box warning for Actos regarding
possible heart failure risks in 2007, the warnings became even more
stringent this past June.
Actos® Damages and Typical Settlements
The
Type 2 diabetes drug Actos is one of a class of drugs known as
thiazolidinediones and has recently been linked to an increased risk of
bladder cancer, liver disease and cardiovascular issues. The FDA felt
that the link between heart failure and Actos was serious enough to
require increased warnings on the drug packaging concerning congestive
heart failure. According to the Washington Post on 8/05/11, the first
of what is expected to be literally thousands of lawsuits was filed
alleging the use of Actos resulted in bladder cancer. Takeda
Pharmaceuticals, a Japanese corporation is the manufacturer of Actos
although it was jointly launched with the American company, Eli Lilly.
Actos quickly became a top-seller of the giant pharmaceutical
corporations, becoming the tenth best-selling drug in the United States
in 2008 with sales over 2.5 billion dollars increasing to a staggering
4.3 billion in 2010.
In June of
2011, Takeda halted its sales of Actos in both France and Germany after
receiving considerable pressure from health regulators in both those
countries. New Zealand is currently in the process of pulling the drug
as well. Since June, both the FDA and the European Medicines Agency have
prudently issued warnings regarding the potential risk of bladder
cancer for those taking the drug, but are allowing the continuation of
sales pending further studies. The FDA has, however, warned doctors not
to prescribe the drug for those who have a history of bladder cancer or
who currently have bladder cancer.
Actos® FDA Safety Review/Warning
On
June 15, 2011, the United States Food and Drug Administration informed
the public that using the drug Actos, commonly prescribed in the
treatment of Type 2 diabetes, has been positively associated with an
increased risk of bladder cancer. Actos is manufactured by a Japanese
pharmaceutical company, Takeda Pharmaceuticals, and is typically sold
either as a single-ingredient product or in combination with the drug
metformin. Actos is prescribed, along with diet and exercise, to help
control blood sugar in adults. Initially the FDA’s safety warnings were
based on a five-year interim analysis of an ongoing ten year study
regarding the risks for those taking Actos.
While
the study at the five-year mark noted an increased risk of bladder
cancer among those who had taken Actos in the highest dosages and for
the longest periods of time, it was unclear about the overall increased
bladder cancer risk. Two other countries, France and Germany, have taken
more definitive actions regarding Actos, believing it poses serious
health risks. While France has suspended the use of Actos altogether,
Germany has recommended to physicians that they not start new patients
on the drug. New Zealand is currently in the midst of recalling the
drug, yet the FDA continues to maintain that further study is warranted
before issuing more stringent warnings.
Actos® Side Effects other than Heart Disease and Bladder Cancer
Osteoporosis and Bone Fractures
While
many people are now aware of the association between the Type 2
diabetes drug, Actos, and both bladder cancer and heart disease, there
are several other quite serious side effects also associated with the
drug. For instance, there is strong evidence to suggest that Actos, like
its sister-drug, Avandai, may cause osteoporosis and bone fractures
among those taking it, most especially in female patients. In one
particular randomized trial which studied patients with Type 2 diabetes
who were currently taking Actos, an increased occurrence of bone
fractures was observed in the female patients and in a follow-up study
at nearly three years, almost 5.1% of the females taking Actos had
suffered a bone fracture.
Most
of the bone fractures were seen in arms and legs, and there was no
apparent escalation of fracture occurences among male patients. Because
this drug study lasted less than five years, it is strongly believed
that a much greater frequency of fractures and osteoporosis would be
seen in women taking Actos for longer periods of time. Since men
typically have much stronger bones than women, fractures and
osteoporosis would probably not have been seen in men who were studied
for only a few years. Since broken hipbones happen to be a primary
killer of the elderly, seniors should not take Avandia or Actos as their
benefits do not appear to outweigh the serious side effects.
