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® 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® 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® and Myocardial InfarctionAfter a Journal of American Medical Association publication of a meta-analysis suggested that long-term use of the diabetes drug Avandia was associated with an increased risk of myocardial infarction, the maker of Avandia, GlaxoSmithKline, declared there was little difference in the safety profile of their drug, Avandia and the “other” drug for Type 2 diabetes, Takeda Pharmaceutical’s Actos. Further studies however have not completely backed up that declaration. In nineteen separate controlled trials, involving over 16,000 patients, the end results demonstrated that while 4.4 percent of the patients who received Actos underwent myocardial infarction or stroke 5.7 percent of patients receiving control therapy suffered a myocardial infarction. In the same studies, serious heart failure was reported in 2.3 percent of those taking Actos, while only occurring in 1.8 percent of those in the control group. The author of the results of the studies, Michael Lincoff, stated that not only does Actos—also known as pioglitazone—not appear to have the same level of detrimental effects as Avandia, but it could potentially have a protective effect on the heart. Takeda Pharmaceuticals, currently struggling under the rash of lawsuits filed against them due to evidence that Actos may significantly increase the risk of bladder cancer, does not believe their drug is responsible for episodes of myocardial infarction, or heart attack.
Actos® European Recall and FDA StanceA wave of recent studies which definitively link the prescription drug Actos—prescribed for Type 2 diabetes—to bladder cancer gives a fairly clear indication that Takeda Pharmaceuticals may soon be flooded with Actos lawsuits. August, 2011, saw the first Actos lawsuit filed by a 54-year old woman from Pennsylvania who had taken Actos for over a decade, then was diagnosed with bladder cancer. It is likely this particular victim may end up having her bladder removed and be subject to chemotherapy treatments due to the unexpected and severe side effects of Actos. Although the FDA has made substantial changes in labeling for Actos, they have refused to go as far out on the limb as other countries who have issued recalls of the drug. France’s Medical Regulatory Agency made the decision to recall Actos once the serious side effects became known. Some 230,000 people regularly take Actos in France, and the possibility of an increase in bladder cancer was felt to be too great to allow patients to continue to take the drug. Soon after, Germany’s health regulators advised physicians to stop prescribing Actos for their patients with Type 2 diabetes due to the potentially dangerous side effects of the drug. These recalls and prohibitions were made after the European Medicines Agency conducted its own study of drugs which contained pioglitazone.
FDA Approves Cancer Warning for Diabetic Drug ActosThe
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 PioglitazoneOther
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 InJust
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.
Pioglitazone Receives New Warnings Due to Slight Increase in Bladder Cancer RiskThe
health review of the Type 2 diabetic drug, pioglitazone, performed by
the European Medicines Agency, confirmed the drug remains a valid
treatment option for certain patients while acknowledging a minimal
increase in bladder cancer risk. The caveat in the conclusions of the
health review centered upon advising physicians to use care and caution
when prescribing the drug. The results further stated that those who are
prescribed pioglitazone—especially those who take relatively high doses
or have taken the drug for longer than a year—must have their overall
health monitored closely. Exclusion of certain higher risk groups, such
as the elderly is also recommended. Assessing Risk Factors in Potential PatientsPhysicians
are warned to screen patients carefully, and avoid prescribing
pioglitazone to those who have a history of bladder cancer or who
currently have bladder cancer. Patients with uninvestigated macroscopic
haematuria are also advised against taking pioglitazone. As stated, age
carries a specific risk, as the elderly are already more likely to
develop bladder cancer based solely on age. Because of this an
alternative diabetes medication with less risk in this area should be
prescribed. Patients taking Actos should undergo regular 3-6 month
reviews to assess and monitor benefit vs. risk. Sources of InformationIn
making its safety recommendations, the Committee for Medicinal Products
for Human Use considered results of pre-clinical and clinical studies
as well as spontaneous reports and epidemiological studies. The
Scientific Advisory Group on Diabetes also weighed in with advice
regarding pioglitazone. The CHMP concluded from this array of evidence
that while there is a slight increase in bladder cancer among those
taking pioglitazone, this risk exists primarily in those who take the drug for long periods of time or in relatively high doses. That being
said, those who take the drug for a short amount of time cannot be
excluded from the risks.
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.
Benefit-Risk Balance Deemed Positive for Type 2 Diabetics Taking PioglitazoneFollowing
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.
FDA Issues Sterner Warnings to Manufacturers of Diabetic Drug ActosAlthough
the FDA issued recommendations regarding labeling cautions for the drug
Actos to manufacturer Takeda Pharmaceuticals in 2006, following further
safety reviews of the drug they have recently issued more stringent
instructions to the Japanese company. Actos, also known as pioglitazone
is used in the treatment of Type 2 diabetes to help control the levels
of sugar in the blood. Drugs Included, Safety Updates RequiredI
n
a letter to Takeda Pharmaceuticals the FDA states that supplemental new
drug applications for Actos, Actoplus Met, Actoplus Met XR and Duetact
were duly received and processed, and noted receipt of certain
amendments and risk evaluation assessments relating to Actos. Takeda was
notified of new safety information which the FDA deemed to be a
necessary inclusion of any future labeling of Actos. Further, the FDA
stated the safety updates must specifically address the potential risk
in increase of bladder cancer in those taking higher dosages or taking
the drug for extended periods of time. Specific Changes to Labeling of ActosThe
FDA asked that Takeda include under the warnings and precautions area
of the Actos label a statement that preclinical and clinical trials had
shown pioglitazone users experienced an increase in incidence of bladder
cancer. The Actos labels must state that those who have bladder cancer
or a prior history of bladder cancer should be extremely cautious when
using the drug. The label must additionally state that statistical
significance in bladder cancer risk is reached in those patients taking
Actos for longer than two years. More specifically, the wording that
taking Actos longer than twelve months increases the risk of developing
bladder cancer to a 40% statistical probability is to be included.Patient Counseling InformationThe
FDA’s advice to patients taking the drug includes immediately reporting
any signs or symptoms of urinary urgency, dysuria or macroscopic
hematuria to their treating physician, as these can be signs of bladder
cancer. Blood or red color in the urine or pain while urinating are all
serious side effects and should be relayed immediately to the patient’s
doctor. Actoplus Met, Actoplus Met XR and Duetact must all be labeled in
the same manner as Actos according to FDA findings.
No Recall Yet for Type 2 Diabetes Drug, Actos
The FDA has joined forces with France and
Germany regarding a warning about the Type 2 diabetes drug,
pioglitazone, however no recall is expected at this time. Pioglitazone,
also known as Actos, is manufactured by Takeda Pharmaceuticals, a
Japanese drug company. The drug currently accounts for some 27% of
Takeda’s annual revenues. 2008 saw this powerhouse diabetes medication
become the tenth best-selling prescription medication in the United
States. Over the past year, Takeda has accrued nearly $4.8 billion
dollars in revenues through worldwide sales of Actos. Clinical Studies of PioglitazonePre-clinical
studies—in which male rats were given body-weight equivalent doses of
Actos—showed an increase in the incidence of bladder cancer while two
subsequent clinical studies using human subjects also revealed an
elevated risk of bladder cancer. Due to these findings, the FDA mandated
that the potential risks be revealed on the label of the drug, ordering
a safety review in September, 2010. Takeda additionally agreed to
carry out a ten-year observational study in those diabetic patients
currently taking Actos, to be conducted on patients from Kaiser
Permanente Northern California Health Plan.
