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. It
has been hypothesized that the way in which Actos reacts with these
receptors may also be the reason it contributes to the risk of bladder
cancer. Potential symptoms of bladder cancer include bloody urine,
chronic and persistent infections of the bladder, a strong urge to
urinate or pain and burning during urination. X-rays may reveal an
abnormality in the bladder walls, or red blood cells found in the urine
during lab tests. If the bladder is swelling, a biopsy may be done or a
growth in the bladder could be discovered through a CT or MRI scan.
Bladder cancer is typically treated with removal of the tumor, surgical
removal of all or part of the bladder or with drugs which help the
immune system fight the cancer. Could Actos Damage Your Liver or Kidneys?In
addition to potentially damaging the heart and bladder, Actos may also
be linked to rhabdomyolysis which occurs when muscle fibers rapidly
bread down releasing proteins and myoglobin into the blood stream.
Myoglobin can be toxic to the kidneys, leading to the development of
rhabdomyolysis. Symptoms of this serious kidney disease include muscle
pain or tenderness, stiffness or weakness in the joints and dark-colored
urine. Actos has also been documented to cause elevated liver enzymes, a
precursor to liver damage. Anyone who is considering taking Actos
should have their liver enzymes tested before they start taking the
drug, and should periodically monitor the liver enzymes while on Actos.
Actos® Adverse EffectsMany of us would be very surprised to find that a drug can be approved by the FDA yet still have serious—and undisclosed—side effects. The drug Actos, used in the treatment of Type 2 diabetes, is one such drug. Actos works by decreasing the body’s resistance to insulin as a way of controlling blood sugar levels. Actos is currently being used by millions of people across the globe, with sales jumping from around $2.9 billion in 2006 to over $4.3 billion in 2010. Actos has often been prescribed in place of the drug Avandia, which was found to carry significant risks of heart disease and possibly even death in 2007. Actos, which is manufactured by the Japanese pharmaceutical giant Takeda Pharmaceuticals, has recently fallen under scrutiny as well as studies have linked it to an increased risk of bladder cancer as well as correlating it to other serious diseases such as heart attack, stroke and liver failure. “Minor” Side Effects of ActosThe truth is, all prescription medicines as well as most over-the-counter medications, carry some risk of adverse effects. Fortunately the incidence of serious side effects is rare and for the most part the majority of people have either no side effects or relatively minor ones. Minor side effects associated with Actos include flu-like symptoms, headaches, toothache, sore throat or sinus pain and weight gain. More serious side effects which should prompt the user to seek medical attention include an allergic reaction which includes difficulty breathing or chest tightness, blurry vision, symptoms of heart or liver failure including breathing difficulties, a sudden gain in weight, stomach pains, dark urine, jaundice or vomiting, low blood sugar symptoms such as tremors, anxiety or chills, severe and unusual bone pain and total exhaustion along with feeling weak and shaky.
Actos® FDA Safety Review/WarningOn 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.
Takeda Pharmaceuticals Received FDA Instructions for Diabetic Drug Actos The
drug Actos, also known as pioglitazone, has recently come under fire
due to studies showing a slight increased risk of bladder cancer in
those taking high doses of the drug or those who have taken Actos for
longer than two years. Manufactured by Takeda Pharmaceuticals of Japan,
the drug has shown huge gains in popularity in the past few years as it
quickly replaced the drug Avandia which suffered under claims of
increased risk of heart attack and death. Actos is Takeda’s tenth
best-selling drug, making over $3.4 billion dollars in the past year
alone. While the recent safety reviews have alarmed many who are
currently taking the drug, in fact there have been safety concerns
regarding Actos for several years. Warnings are Not NewAs
far back as 2006, the FDA issued instructions to Takeda regarding Actos
and ActoPlus Met, advising the company to make specific label changes
to the drug’s precautionary statements. These label changes were to
specifically include information regarding reports of bladder cancer in
those taking Actos. Takeda’s supplemental drug applications regarding
Actos were approved conditionally, so long as the agreed-upon text was
included in the drug’s labeling. The
FDA stipulated that the final printed label be identical to the
proposed labeling changes, and required Takeda to submit an electronic
version of the proposed label as well as 20 paper copies and fifteen
copies mounted on heavy-weight paper, however final approval was not
mandated prior to using the labels. Although these FDA instructions took
place nearly five years ago, it was only recently that more stringent
warnings regarding Actos were issued.
FDA Approves Cancer Warning for Diabetic Drug Actos
The
blockbuster drug, Actos, which is prescribed to control Type 2
diabetes, has received new warning language on the label regarding a
potential risk of bladder cancer for those taking the drug. Actos, also
known as pioglitazone, is manufactured by Takeda Pharmaceuticals, a
Japanese-based company, and is currently their best-selling drug, with
sales of $3.4 billion last year alone. Sales of Actos had shown a
significant upswing due to the fact that its primary
competitor—Avandia—has been linked to a higher risk of heart attack and
even death. The updated label warnings came on the heels of an EMA
safety review of the drug as well as a ten-year study conducted by
Takeda. The Takeda study indicated a statistically significant increase
in the risk of bladder cancer for those taking the drug for longer than
two years.
Other Drugs Containing Pioglitazone
Other
than Actos, the drugs ActoPlus Met, ActoPlus Met XR and Duetact will
all carry the same warnings due to containing pioglitazone as an active
ingredient. All of these drugs are used to treat Type 2 diabetes, to
increase sensitivity to insulin and effectively control blood sugar
levels. A combination drug containing metformin and pioglitazone is used
for the same purpose, although all these drugs are expected to be used
in conjunction with a healthy diet and sensible exercise program.
France and Germany Weigh In
Just
this past June, both France and Germany issued recalls of Actos
following a public insurance data review which showed a fairly strong
correlation between pioglitazone and bladder cancer risk. Suggestions
from the EMA study related primarily to including more cautionary
warnings on the labels of the drug as well as a six-month review of each
patient taking Actos.
European Medicines Agency Scientific Studies on Pioglitazone
The
European Medicines Agency released a scientific study on the benefits
and risks of the drug pioglitazone, also known as Actos, in January of
2007. This drug is currently used as a single treatment for Type 2
diabetes or in a dual combination form with metformin or sulphonylurea.
When used alone, pioglitazone is typically used as therapy for the
overweight patient whose Type 2 diabetes is not being controlled through
diet and exercise and for whom the drug metformin is inappropriate. The
combination drug is most often used in those patients who have
insufficient glycemic control despite taking metformin alone or for
those patients who have shown a level of intolerance to metformin. The
results of the study showed that when pioglitazone was prescribed in
conjunction with other anti-diabetic therapies such as insulin, the risk
of macrovascular disease was greatly reduced. Macrovascular disease is
common in those with long-term diabetes and refers to a disease of the
large blood vessels in the body. Clinical Support for Pioglitazone ApplicationEvidence
was submitted which supported the application of pioglitazone,
including four clinical trial reports which studied the safety of the
drug when used in conjunction with insulin therapy. The studies were
conducted according to prevailing ethical standards, and were random,
double-blind, placebo controlled. First Pioglitazone Study—PNFP-014Pioglitazone
was administered both in 15 mg dosages as well as 30 mg dosages in
combination with insulin then compared with using insulin therapy alone.
Participants in the studies were between the ages of 30 and 75, and had
been on a fixed dose of insulin for at least a month prior to beginning
the study. The mean baseline age was 57 years, with an average BMI of
33.6. Nearly 3/4ths of the participants in the study were Caucasian,
with slightly more than half being female. Although the baseline
systolic blood pressure was minimally higher in the group receiving
pioglitazone plus insulin as opposed to the group receiving insulin
alone, there were no other baseline variables involved. The patients who
received both pioglitazone and insulin showed statistical decreases in
the HbA1c levels which measure the average amount of sugar in the blood
over a period of three months, and is different from glucose
measurements. The HbA1c levels essentially give the physician an
indication of how well the diabetes is being controlled.
Benefit-Risk Balance Deemed Positive for Type 2 Diabetics Taking Pioglitazone
Following safety reviews of the drug
pioglitazone—a medicine used in the treatment of Type 2 diabetes—the
European Medicines Agency delivered their decision that while there is a
marginally increased risk of bladder cancer in those taking the drug,
it remains a viable treatment option for some patients. Pioglitazone,
also sold under the brand name Actos, is used along with a sensible diet
and exercise program to increase the body’s sensitivity to insulin,
thereby controlling blood sugar levels.Reducing Potential RisksThe
EMA’s conclusions following extensive study of the drug was that the
slight increased risk of bladder cancer could be alleviated through
implementation of a more stringent screening of potential patients.
Medical professionals are warned against prescribing pioglitazone in any
patients with a history of bladder cancer, and to exercise caution when
prescribing the drug to the elderly as well. Those
patients deemed good candidates for pioglitazone should nonetheless be
monitored closely every three to six months to ensure the benefits
continue to outweigh the risks. High Doses, Significant Duration LinkedThe
results of the controlled epidemiological studies determined that the
small risk associated with pioglitazone was seen primarily in those
patients who took the drug for significant lengths of time and in the
highest doses. Even though the studies showed only a 0.15% increase in
risk of bladder cancer this does not mean that those who are prescribed the drug for short term use have no risk at all of contracting bladder cancer.
