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Actos Bladder Cancer Lawsuit, Actos Cancer Death Lawsuit, Diabetes Drug
Bladder Cancer Lawsuit, Actos Heart Attack Lawsuit,
Actos Cancer Lawsuit, and Actos Diabetes Drug Injury Lawsuit
Information
by Texas Actos Bladder Cancer Lawyer and Actos Cancer
Death Lawyer
Scientific research has shown that
the Diabetes Drug Actos may
cause an increased risk of bladder cancer.
Bladder Cancer is a form of cancer that begins in the lining
of the bladder as a superficial tumor. Bladder cancer
can spread and metastasize into the lungs, liver, or bones
resulting in serious health issues and even death. The
most common symptom of bladder cancer is blood in the urine. If you
or a loved one have been taking Actos and have experienced
blood in your urine, please contact your doctor immediately.
If you suffer a from
bladder cancer or
have lost a person that you love
from a bladder cancer and you or your loved one was taking Actos,
please feel free to e-mail Texas Actos
Bladder Cancer Lawyer and Actos Cancer Death Jason Coomer with your name & contact
information or use our online
form for a free case evaluation.
Actos Bladder Cancer Lawyer, Actos Cancer Death Lawyer, Diabetes Drug
Bladder Cancer Lawyer, Actos Heart Attack Lawyer, Actos
Cancer Lawyer, and Actos Diabetes Drug Injury Lawyer
Most bladder cancers begin in the
transitional cells as transitional cell carcinoma, but can
spread into nearby organs. When bladder cancer spreads
beyond the bladder, the malignant cells are frequently found
in nearby lymph nodes and may have spread to other lymph
nodes or other places including the lungs, liver, or bones.
The most common warning sign is blood in the urine. If there
is enough blood to color the urine it may range from
slightly rusty to deep red. Other symptoms may be pain
during urination and frequent urination or feeling the need
to urinate without results.
Bladder cancer can be diagnosed into
several different stages. Stage 0 Bladder Cancer
patients have noninvasive tumors that are
only in the bladder lining; Stage I Bladder Cancer Patients
have tumor(s) through the bladder
lining, but the tumor(s) do not reach the muscle layer of the bladder; Stage II
Cancer Patients have tumor(s) that go into the muscle
layer of the bladder; Stage III Cancer Patients have tumor(s)
that go past the muscle
layer into tissue surrounding the bladder; and Stage IV
Bladder Cancer Patients have tumor(s) that have spread to
neighboring lymph nodes or to distant sites (metastatic
disease) including the lungs, liver, bones, prostate,
stomach, rectum, ureters, uterus, and vagina.
Primary malignant bladder cancer can be
classified by health care providers in several different
categories depending on where it is found including the dome
of urinary bladder; lateral wall of urinary bladder;
anterior wall of urinary bladder; posterior wall of urinary
bladder; bladder neck; ureteric orifice; urachus; and
malignant neoplasm of contiguous or overlapping sites of
bladder whose point of origin cannot be determined.
Carcinoma in situ is cancer that remains
confined to the bladder lining. Bladder cancer may grow into
or through the bladder wall and eventually into lymph nodes,
lungs, liver, bones, or other nearby areas.
Actos Bladder Cancer Lawyers, Actos Lawyers, Diabetes Drug
Lawyers, Actos Cancer Lawyers, Actos Heart Attack Lawyers, Actos Broken Bones Lawyers, and Actos Diabetes Drug Lawyers
Actos has been prescribed
to more than 10 million Americans since its approval for the
treatment of type 2 diabetes. The popular diabetes drug,
Actos,
manufactured by Takeda Pharmaceutical Co, has been linked to
increased
risk of bladder cancer and has been pulled off the market in
some European countries. Actos is now under review by
the FDA to determine if it will be pulled from the market or
additional black box warnings will be added to the drug.
Actos is a diabetes drug with
that had multibillion dollar annual
global sales. Recent
scientific evidence has recently shown
that the Diabetes Drug Actos may cause an increased risk of
bladder cancer. If left untreated bladder cancer can
metastasize into lung cancer lymphatic
cancer, liver cancer, bone cancer, prostate cancer, rectum
cancer, uterine cancer, and vaginal cancer.
FDA Drug Safety Communication: Ongoing Safety
Review of Actos (pioglitazone) and Potential Increased Risk
of Bladder Cancer After Two Years Exposure
On September 17, 2010, the U.S. Food and
Drug Administration (FDA) announced that they are reviewing
data from an ongoing, ten-year epidemiological study
designed to evaluate whether Actos (pioglitazone), is
associated with an increased risk of bladder cancer.
Findings from studies in animals and humans suggest this is
a potential safety risk that needs further study.
Actos is used along with diet and
exercise to control blood sugar or improve control of blood
sugar in adults with type 2 diabetes mellitus. Bladder
cancer is estimated to occur in 20 per 100,000 persons per
year in the United States and is thought to be higher in
diabetics.1
The drug manufacturer, Takeda, has
conducted a planned analysis of the study data at the
five-year mark, and submitted their results to FDA. Overall,
there was no statistically significant association between
Actos exposure and bladder cancer risk. However, further
analyses were also performed looking at how long patients
were on Actos and the total amount of the drug they received
during that time. An increased risk of bladder cancer was
observed among patients with the longest exposure to Actos,
as well as in those exposed to the highest cumulative dose
of Actos.
At this time, FDA has not concluded that
Actos increases the risk of bladder cancer. Its review is
ongoing, and the Agency will update the public when it has
additional information. Healthcare professionals should
continue to follow the recommendations in the drug label
when prescribing Actos. Patients should continue taking
Actos unless told otherwise by their healthcare
professional. Patients who are concerned about the possible
risks associated with using Actos should talk to their
healthcare professional.
This communication is in keeping with
FDA's commitment to inform the public about its ongoing
safety review of drugs.
The FDA recommends to patients that they
do not stop taking Actos unless told to do so by your
healthcare professional. FDA has not concluded that Actos
increases the risk of bladder cancer. The Agency is
reviewing this safety concern and will update the public
when additional information is available. Talk to your
healthcare professional if you have concerns about Actos.
Report any side effects from the use of Actos to the FDA
MedWatch program, using the information in the "Contact Us"
box at the bottom of the page.
The FDA provided the following notice to
Healthcare Professionals. The FDA has not concluded
that Actos increases the risk of bladder cancer. The Agency
is reviewing information related to the safety concern and
will update the public when additional information is
available. Follow the recommendations in the drug label when
prescribing Actos. Continue to report adverse events
involving Actos to the FDA MedWatch program.
Data Summary
Actos was approved July 15, 1999 as an
adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus. Across the approved
doses Actos reduced HbA1c compared to placebo by an average
of 1.5%.
In preclinical carcinogenicity studies of
pioglitazone, bladder tumors were observed in male rats
receiving doses of pioglitazone that produced blood drug
levels equivalent to those resulting from a clinical dose.
Additionally, results from two, three-year controlled
clinical studies of Actos (the PROactive study2 and a liver
safety study) demonstrated a higher percentage of bladder
cancer cases in patients receiving Actos versus comparators.
These findings are currently included in the
Precautions--Carcinogenesis, Mutagenesis, Impairment of
Fertility section of the Actos drug label.
To further address the long-term risk of
bladder cancer associated with Actos use the drug
manufacturer, Takeda, is conducting a ten-year,
observational cohort study as well as a nested case-control
study in patients with diabetes who are members of Kaiser
Permanente Northern California (KPNC) health plan.3 Patients
selected in this study had diabetes mellitus and were >40
years of age at study entry. Patients with bladder cancer
prior to study entry or within six months of joining KPNC
were excluded from this study. The cohort included 193,099
patients with diabetes.
The primary outcome of the cohort study
is an incident (new) diagnosis of bladder cancer identified
from the KPNC cancer registry. The primary exposure of
interest is treatment with Actos. Data on drug dose,
duration of exposure and potential confounding factors are
also obtained in the study.
A planned five-year interim analysis was
performed with data collected from January 1, 1997 through
April 30, 2008. The median duration of therapy among Actos-treated
patients was 2 years (range 0.2-8.5 years). The study
investigators did not observe a statistically significant
association between any Actos exposure and increased bladder
cancer risk in the study (Hazard ratio = 1.2, 95% Confidence
Interval: 0.9-1.5). However, the risk of bladder cancer
increased with increasing dose and duration of Actos use,
reaching statistical significance after 24 months of
exposure.
FDA is reviewing the data from this
observational cohort study and a case control study that is
nested within it, and will update the public in several
months when the review is complete or earlier should
additional data become available.
Bladder Cancer Stages, Bladder Cancer Symptoms, and
Bladder Cancer Treatments
Bladder cancers are classified, or
staged, based on their aggressiveness and how much they
differ from the surrounding bladder tissue. There are
several different ways to stage tumors. Recently, the TNM
(Tumor, Nodes, Metastasis) staging system has become common.
Stage 0 Bladder Cancer patients have noninvasive tumors that are
only in the bladder lining; Stage I Bladder Cancer Patients
have tumor(s) through the bladder
lining, but the tumor(s) do not reach the muscle layer of the bladder; Stage II
Cancer Patients have tumor(s) that go into the muscle
layer of the bladder; Stage III Cancer Patients have tumor(s)
that go past the muscle
layer into tissue surrounding the bladder; and Stage IV
Bladder Cancer Patients have tumor(s) that have spread to
neighboring lymph nodes or to distant sites (metastatic
disease) including the lungs, liver, bones, prostate,
stomach, rectum, ureters, uterus, and vagina. Bladder cancer can metastasize or spread
by extending into the nearby organs or through the lymph
nodes. It can spread into the Prostate, Rectum,
Ureters, Uterus, Vagina, Bones, Liver, and Lungs.
Bladder cancer can manifest through many
different symptoms. Most of these symptoms can also
occur with non-cancerous conditions. However, if you have
these symptoms and a suspect bladder cancer, it is important
to get evaluated by a qualified medical doctor to determine,
if you may have bladder cancer. Some of these symptoms
include: 1) Blood in the urine, 2) Painful urination, 3)
Urinary frequency, 4) Urinary urgency, 5) Abdominal pain, 6)
Anemia, 7) Bone pain or tenderness, 8) Lethargy or fatigue,
9) Urinary incontinence, and 10) Weight loss.
Testing for bladder cancer can include
performing 1) a physical examination, including a rectal and
pelvic exam, 2) Abdominal CT scan, 3) Bladder biopsy
(usually performed during cystoscopy), 4) Cystoscopy
(examining the inside of the bladder with a camera), 5)
Intravenous pyelogram - IVP, 6) Urinalysis, and 7) Urine
cytology.
There are several types of treatment for
bladder cancer. The selection of treatment for bladder
cancer will vary depending on the patient, health care
provider, and stage of bladder cancer. In Stages 0 and I,
surgery is usually performed to remove the tumor without
removing the rest of the bladder. Also, chemotherapy
or immunotherapy can be applied directly into the bladder.
People with stage 0 or I bladder cancer can be treated with
transurethral resection of the bladder (TURB). This surgical
procedure is performed under general or spinal anesthesia. A
cutting instrument is inserted through the urethra to remove
the bladder tumor.
In Stages II and III treatment,
chemotherapy can be used to shrink the tumor before surgery,
then surgery can be performed to remove the entire bladder
(radical cystectomy) or surgery can be performed to remove
only part of the bladder, followed by radiation and
chemotherapy. For bladder cancer patients that cannot
have surgery or choose not to have surgery, a combination of
chemotherapy and radiation can be used.
Many people with stage II or III bladder
cancer may need to have their bladder removed (radical
cystectomy). Partial bladder removal may be performed in
some patients. Removal of part of the bladder is usually
followed by radiation therapy and chemotherapy to help
decrease the chances of the cancer returning. Patients who
have the entire bladder removed will receive chemotherapy
after surgery to decrease the risk of the cancer coming
back.
Radical cystectomy in men usually
involves removing the bladder, prostate, and seminal
vesicles. In women, the urethra, uterus, and the front wall
of the vagina are removed along with the bladder. Often, the
pelvic lymph nodes are also removed during the surgery to be
examined in the laboratory.
A urinary diversion surgery (a surgical
procedure to create an alternate method for urine storage)
is usually done with radical cystectomy. Two common types of
urinary diversion are an ileal conduit and a continent
urinary reservoir. An ileal conduit is a small urine
reservoir that is surgically created from a small segment of
bowel. The ureters that drain urine from the kidneys are
attached to one end of the bowel segment. The other end is
brought out through an opening in the skin (a stoma). The
stoma allows the patient to drain the collected urine out of
the reservoir. People who have had an ileal conduit need to
wear a urine collection appliance outside their body at all
times. A continent urinary reservoir is an alternate
method of storing urine. A segment of colon is removed. It
is used to create an internal pouch to store urine.
This surgery is becoming more common in
patients undergoing cystectomy. A segment of bowel is folded
over to make a pouch (a neobladder, which means "new
bladder"). Then it is attached to the place in the urethra
where the urine normally empties from the bladder. This
procedure allows patients to maintain some normal urinary
control. However, there are complications (including urine
leakage at night). Urination is usually not the same as it
was before surgery.
Unfortunately, for most patients with
stage IV tumors, the bladder cancer cannot be cured and
surgery will not appropriate. In these stage IV bladder
cancer patients, chemotherapy is often considered.
Actos Bladder Cancer Lawyers, Actos Lawyers, Diabetes Drug
Cancer
Lawyers, Actos Cancer Lawyers, Actos Heart Attack Lawyers, Actos
Cancer Death Lawyers, and Actos Diabetes Drug Lawyers
Texas Actos Bladder Cancer Attorney Jason Coomer commonly works with other lawyers throughout Texas,
the United States, and the World
including Houston Actos Bladder Cancer Lawyers, San Antonio
Bladder Cancer Lawyers, Dallas Actos Lawyers,
New York Actos Lawyer, Chicago Actos Cancer Lawyers, and other
Texas Actos Bladder Cancer Lawyers. By
sharing information and working together, his law firm and
other firms throughout World are able to provide better
representation for there clients.
Actos Bladder Cancer Lawyer, Actos Cancer Lawyer, Diabetes Drug
Bladder Cancer Lawyer, Actos Heart Attack Lawyer, Actos
Stroke Lawyer, and Actos Diabetes Drug Cancer Death Lawyer
If you or a loved one have been
taking Actos and have experienced blood in your urine,
please contact your doctor immediately. If you suffer a
from
bladder cancer or
have lost a person that you love
from a bladder cancer and you or your loved one was taking Actos,
please feel free to e-mail Texas Actos
Bladder Cancer Lawyer and Actos Cancer Death Jason Coomer with your name & contact
information or use our online
form for a free case evaluation.
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