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Actos Bladder Cancer
Lawsuit, Actos Cancer Lawsuit, Actos Heart Attack Lawsuit, Actos
Stroke Lawsuit, and Actos Cancer Death Lawsuit Information
by Texas Actos Bladder Cancer Lawyer, Actos Heart Attack
Lawyer, Actos Cancer Attorney, and Actos Cancer Death Lawyer
Scientific evidence has shown that the Diabetes Drug Actos may cause an
increased risk of bladder cancer as well as heart problems in
patients that are prescribed the drug. As these dangers
were not disclosed by the drug manufacturer as soon as they were
discovered, several Actos Bladder Cancer Lawsuits, Actos Stroke
Lawsuits, and Actos Heart Attack Lawsuits have been filed and
are being filed. For more information regarding Actos Bladder Cancer Lawsuits, Actos
Heart Attack Lawsuits, Actos Stroke Lawsuits, and Actos Cancer
Death Lawsuits,
please feel free to e-mail Texas Actos Bladder Cancer Lawyer
Jason Coomer with your name & contact information or
use
our online form for a free case evaluation.
Actos Bladder Cancer
Lawsuit, Actos Cancer Lawsuit, Actos Heart Attack Lawsuit, Actos
Stroke Lawsuit, and Actos Cancer Death Lawsuit Information
Actos has been prescribed to more than 10
million Americans since its approval for the treatment of type 2
diabetes. The widespread use and multi-billion dollar
annual sale of the drug mean that 10 of millions of people have
been exposed to an increased risk of
bladder cancer, while the drug company reaped huge rewards from
the drug.
Where drug manufacturers are aware of fatal
risks of a drug, but continue to sell and promote the drug
lawsuits are needed. Consumers that were sold a defective
product without warning of potentially fatal risks and suffered
the loss of a loved one or serious health problems from the drug
have a right to seek compensation for the wrongful acts of the
drug company.
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.
References
Seer Stat Fact Sheets: Urinary Bladder.
National Cancer Institute Web site. Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html.
Accessed September 16, 2010. Dormandy JA, Charbonnel B, Eckland
DJ, Erdmann E, Massi-Benedetti M, Moules IK, et al. Secondary
prevention of macrovascular events in patients with type 2
diabetes in the PROactive Study (PROspective pioglitAzone
Clinical Trial In macroVascular Events): a randomised controlled
trial. Lancet. 2005;366:1279-89. Lewis JD, Ferrara A, Strom BL,
Selby JV, Bilker W, Peng T, et al. The risk of bladder cancer
among diabetic patients treated with pioglitazone: analysis
through April 30, 2008. University of Pennsylvania and Kaiser
Permanente Northern California Division of Research. Submitted
to FDA, unpublished results.
- Related Information
FDA Drug Safety Podcast for Healthcare
Professionals: Ongoing Safety Review of Actos (pioglitazone) and
Potential Increased Risk of Bladder Cancer After Two Years
Exposure Actos (pioglitazone): Ongoing Safety Review - Potential
Increased Risk of Bladder Cancer MedWatch - 9/17/2010 FDA
reviewing preliminary safety information on Actos (pioglitazone)
FDA Note to Correspondents - 9/17/2010 SEER Stat Fact Sheets:
Urinary Bladder Pioglitazone HCl (marketed as Actos, Actoplus
Met, and Duetact) Information
Actos Bladder Cancer Lawsuit, Actos
Cancer Lawsuit, Actos Heart Attack Lawsuit, Actos Stroke
Lawsuit, Actos Bladder Cancer Lawyer, Actos
Lawyer, Diabetes Drug Lawyer, Actos Cancer Death Lawyer, Actos
Heart Attack Lawyer, and Actos Cancer Lawyer Information
Texas Dangerous Drug 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 Actors Lawers, 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.
If you or a loved one has taken Actos and is
suffering from bladder cancer, a stroke, heart attack, or other health
problems, it is important to discuss the health issue with your
doctor and make sure they understand the potential health issues
that Actos can cause. For more information regarding Actos Bladder Cancer Lawsuits, Actos
Heart Attack Lawsuits, Actos Stroke Lawsuits, and Actos Cancer
Death Lawsuits,
please feel free to e-mail Texas Actos Bladder Cancer Lawyer
Jason Coomer with your name & contact information or
use
our online form for a free case evaluation. |
